GSK Weight-Loss Drugs Rapped With Warning Label

Image: plastic-fantastic-dolly.blogspot

Quite confusing is this latest announcement from the FDA.

They [FDA] have now added warning labels to GlaxoSmithKline's Alli, the over the counter weight loss pill that was expected to earn the company billions of dollars when it was launched in 2007.

The warnings, writes Katherine Hobson of the Wall Street Journal Health Blog, will advise people taking orlistat — the active ingredient in both drugs to be on the lookout for itching, yellow eyes or skin, dark urine and loss of appetite, all of which are symptoms of liver problems.

Sales of Alli have been less than remarkable which could possibly be down to the number of adverse reports submitted the the regulator of which anal leakage is one of the more popular of the many reported.

The FDA have also added a warning label to what is basically a prescription version of Alli, namely Xenical.

Xenical is manufactured by Roche and sold by GSK.

Wikipedia writes:

Orlistat (marketed as a prescription under the trade name Xenical by Roche in most countries, or over-the-counter as Alli.

Confused?

GSK said in a statement it is "committed to ensuring that consumers and physicians understand the safety profile" of alli.

“GSK is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli," said Howard Marsh, chief medical officer for GSK Consumer Healthcare.

"Although reports of serious liver injury in people taking orlistat are rare, GSK takes all adverse events reports seriously. Reaching and maintaining a healthier weight is one of the most important things people can do for their health. GSK wants people to have the information they need to choose the right weight loss aid for their situation,” he added.

Alli has been the butt [pun intended] of many jokes since its launch in 2007. One such jibe was a video uploaded to youtube. It was created by the makers of Leptopril, AG Waterhouse IP Holdings LLC. Leptopril, also known as Leptoprin, is a dietary supplement.



This latest announcement comes hot on the heels of the MHRA's announcement yesterday where it appeared that they had been instrumental in the prosecution of a 44 year old man who had been selling unlicensed slimming pills.

MHRA Head of Operations, Danny Lee-Frost, said:

"The products being sold by Mr Green have undergone no quality control and he continued selling these products even after he was made aware of the dangers of what he was doing.

"This is yet another example of the danger of buying any type of drug from an unregulated source. You simply don't know what you are taking, the dosage, the conditions it was made in or most importantly, the effect it might have on your health."

Put Danny Lee-Frost comments with this from the FDA:

The FDA has cautioned that there is a potential, rare occurrence of liver failure in people who take the weight-loss medications Xenical or Alli, both of which contain the active ingredient orlistat. At least 12 cases of severe liver injury have been reported in people taking Xenical and one case has been reported with the use of Alli.

Though the cause-and-effect relationship of severe liver injury with orlistat use has not been established, the FDA has revised the drug labels for Xenical and Alli to include new safety information about the rare occurrence of severe liver injury.

In the words of Danny Lee-Frost, the MHRA's Head of Operations:

"...You simply don't know what you are taking, the dosage, the conditions it was made in or most importantly, the effect it might have on your health."

One has to laugh at the irony.

Full story at the WSJ

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Seroxat/Paxil addiction

Image: i.dailymail.co.uk


Seroxat Secrets has an excellent post regarding Seroxat/Paxil addiction.

The author pulls no punches with his message to GlaxoSmithKline, the FDA and the MHRA.

He writes:

You want to stop taking Seroxat, but when you try to stop, you find you can’t – the physical and mental withdrawal symptoms can include akathesia, agitation, mania, psychosis, self harm, suicidal thoughts and actions, violence, fear of loud noises, electric zaps of the head and body, thoughts of homicide, profuse sweating, disturbing nightmares, lack of empathy toward other people, anger, severe memory loss, nausea.

Not everyone who takes Seroxat will be affected – maybe 35%, maybe 40%, maybe 50%… the fact is that no one knows because Glaxo has never bothered to do any research into the level of Seroxat withdrawal problems nor any research into why some people suffer so badly.

The bottom line is Glaxo actually doesn’t care – it takes the line that there is no problem – Seroxat is safe and it’s easy to stop taking it.

He follows this up with evidence which points to GlaxoSmithKline previously concealing evidence regarding Seroxat.

It's an excellent post and finishes with the Seroxat Secrets author writing:

That’s why I’m looking forward to the High Court case in London and seeing all the previously secret documents that will no doubt become public over the course of the trial.

I echo his sentiments.


FULL POST HERE



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Six Month Prison Sentence For Illegal Sale And Supply Of Slimming Pills

Image: exchangesupplies.org


It appears the MHRA are taking its paymasters competition seriously these days.

Medical News Today is reporting that a 44-year old man received a six month prison sentence last friday for the illegal sale and supply of unlicensed slimming pills.

The article goes on to say that the pills contained a substance called ephedrine, an alkaloid derived from various plants in the genus Ephedra.

MHRA Head of Operations, Danny Lee-Frost, said:

"The products being sold by Mr Green have undergone no quality control and he continued selling these products even after he was made aware of the dangers of what he was doing.

"This is yet another example of the danger of buying any type of drug from an unregulated source. You simply don't know what you are taking, the dosage, the conditions it was made in or most importantly, the effect it might have on your health."

My only surprise here is that Danny Lee-Frost never added "Alli is on sale from all major pharmacy outlets."

Ephedrine has been reported to cause heart palpitations, dizziness and *very* bad mood swings.

Unlike the SSRi's that the MHRA are in denial about then!

You can read more about the MHRA teaming up with Pfizer HERE and HERE.

You can also read about GlaxoSmithKline's over the counter diet pill, Alli and how Glaxo got the ‘With Allies Like This, Who Needs Enemas?’ Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter

The MHRA - Safeguarding public health!

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

The Power to Harm: Mind, Medicine, and Murder on Trial

I've just finished reading an excellent book entitled, The Power to Harm: Mind, Medicine, and Murder on Trial. It was written by John Cornwell and gives you a great insight into the mechanics of the American legal [litigation] system and how pharmaceutical company lawyers, in this case, lawyers representing Eli Lilly, try to muddy the waters of expert witnesses from the side of the plaintiffs.

The book revolves around the tragic case of Joe Wesbecker who went in to his place of employment [Standard Gravure, in Louisville, Kentucky] and shot 20 people, killing 8, before turning the gun on himself.

The plaintiffs, the 12 survivors of Webecker's killing spree, filed a suit against Eli Lily after they had learned that Wesbecker had been prescribed Prozac, a drug manufactured and promoted by Lilly.

What follows is a fascinating account of Wesbecker's background and how Lily's lawyers used this background to defend their drug.

Reading the book one can understand Lilly's defence as Wesbecker had previously been on a cocktail of anti-psychotic medication.

The case is well-known with Prozac activists and the outcome has more twists than a John Grisham novel.

I learned of a new drug whilst reading this book, a drug manufactured by Eli Lilly and one that they fought tooth and nail over behind the scenes [sidebar, Judge's chambers] to not be introduced as evidence in this particular case.

It was a drug that would play a major part in this trial and one that was a leverage for the plaintiffs to strike a 'secret deal' with Lilly's law team.

The verdict of this case is widely known. The Juror's cleared Prozac in the role of these murders. What is largely unknown is the secret deal the defence and plaintiffs struck before that jury verdict was announced. A deal that rested on the introduction of a previous drug manufactured by Eli Lilly - that drug being Oraflex.

Lilly lawyers knew that the Oralflex information would be damaging to their defence and at first the Judge [Judge John Potter] agreed with them that the jury shouldn't hear it.

As the case progressed Lilly's lawyers offered witnesses to make claims of how good their system was for collecting and analysing side effects.

The plaintiffs lawyers pounced and argued that Lilly's lawyers had basically opened the door of rebuttal.

In other words, the plaintiffs could now argue that Lilly's system wasn't as good as they had made out in court.

It was then decided by Judge Potter that the Oraflex information could be introduced and that the jury could hear it.

What followed defies belief and if you had a lack of faith in the judicial system then this book won't comfort you.

If the lawyers for the plaintiffs would have introduced this information then many of the jurors [later interviewed when this came to light] would have put the murders down to Prozac.

Sadly, a deal [unbeknown to Judge Potter] was struck not to introduce this evidence. The plaintiffs and defence had, it appears, agreed on a sum of money not to introduce this damning evidence.

Judge Potter's reaction on learning of this 'secret deal'? Well, you will have to read the book.

It's a great insight into the world and underhand tactics of lawyers who represent pharmaceutical companies and, it has to be said, a world where lawyers for plaintiffs take the lure of the dollar rather than the future safety of patients who take Prozac.

Litigation is all about money but the plaintiffs lawyers in this case had an opportunity to nip future sales of Prozac in the bud. They took the money instead.

Can anyone blame them?

Well, if they would have introduced the Oraflex evidence then they could have left the door open for a mistrial - Lilly's lawyers would no doubt have used this point as part of an appeal process if they would have lost.

The 'payout' is unknown but was believed to be a very handsome amount.

As The Power to Harm: Mind, Medicine, and Murder on Trial went to press [May 1996] Judge John Potter was told that he could conduct a hearing to determine whether Eli Lilly and the plaintiffs has misled the court about the 'pre-verdict' agreement. Potter had previously been told that he could not conduct such a hearing but this was overturned.

Extract: [1]

In the published statement of the Supreme Court, the judges declared that "there was a serious lack of candor with the trial court." They went on to state that "there may have been a deception, bad faith conduct, abuse of judicial process or perhaps even fraud," which was "what the investigation and hearing is to determine."

Commenting on the integrity and authority of American courts of law, the judges wrote that "our system depends on the adversarial presentation of evidence...even the slightest accommodation of deceit or a lack of candor in any material quickly erodes the validity of the precess."

Reacting to the Supreme Court decision, Ed West for Eli Lilly said that even if Potter's court eventually altered the jury verdict to a settlement, "it shouldn't in any way reflect negatively on the product...it's a question of legal procedural wrangling."

You can purchase a copy of The Power to Harm: Mind, Medicine, and Murder on Trial, HERE


[1] The Power to Harm: Mind, Medicine, and Murder on Trial. Copyright John Cornwell 1996

**Lilly suspended sales of Oraflex in 1982 after reports from the British government and the FDA of adverse effects and deaths linked to the drug.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Targeting Pregnant Women

Evelyn Pringle has wrote a fascinating article about the problems with Reglan, a drug used to treat heartburn caused by gastric reflux.

Once again, her investigative journalism tells it like it is. No sugar-coated nonsense from the pen of one of the great writer's out there.

You can access Evie's article HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Paxil/Seroxat. The Gout Connection.

Image: Wikipedia


I've often wondered what can bring on gout, more so as I have witnessed it first hand and have had to alter my eating and drinking habits as a result.

I've been researching these past few days - remedies for gout, causes of gout.

I've asked around my circle of friends, doctor's, psychiatrists, fellow advocates.

What if long term use of an SSRi could actually have a side-effect such as gout. What if this particular side-effect was not included on the patient information leaflet that accompanies these SSRi type pills?

Let's go on a journey with regard to Paxil [UK brand name Seroxat] and gout.

If you use Google and put in the search phrase, "Can paroxetine cause gout?" The result is instant.

http://www.gout-aware.com/Can-paroxetine-cause-Gout.html

Can paroxetine cause Gout?

A question that is being studied constantly and at this stage it is generally known that this drug can be very dangerous for sufferers of Gout especially if they are on any drug or herb to combat or maintain Gout.

...Can paroxetine cause gout? It can certainly affect a sufferer's chances of having a gout attack or severely affecting the function ofthe Liver and kidneys which in turn can have detrimental effects on a Gout attack.

http://patientsville.com/symptoms/gout.htm

Paroxetine Side Effects Report #5617393-X

Consumer or non-health professional from UNITED STATES reported PAROXETINE problem on Aug 09, 2007. Male patient, 55 years of age, was diagnosed with depression and was treated with PAROXETINE. After drug was administered, patient experienced the following problems/side effects: gout, . PAROXETINE dosage: 20MG PER DAY. During the same period patient was treated with ALLOPURINOL. Patient recovered.

http://www.mentalhealth.com/drug/p30-p02.html

Summary Paxil CR

PAXIL CR GlaxoSmithKline
Paroxetine HCI

Metabolic and Nutritional:

Frequent: Weight gain, weight loss.

Infrequent: Edema, hyperglycemia, peripheral edema, thirst.

Rare: Alkaline phosphatase increased, bilirubinemia, dehydration, gout, hypercholesteremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, obesity, AST (SGOT) increased, ALT (SGPT) increased.

So, it would appear that indeed gout has been reported as a side-effect to taking Glaxo's Seroxat. Okay, not many but nonetheless it HAS been reported.

Even the MHRA's website shows gout as a possible side-effect.

Their Drug Analysis Print for paroxetine shows 5 reported cases of gout as a possible side-effect.

Hardly enough to stop the Seroxat conveyor belt at GlaxoSmithKline but yet another side-effect that is not included on the patient information leaflet.

Maybe Glaxo don't feel that gout is serious enough to warrant inclusion on their Seroxat patient information leaflets.

So, it's pretty much proven that Seroxat can cause gout... or at least it's been reported that it can. I can't help but think of all those who have developed gout whilst on Seroxat have not reported it

So what about those of us who do not take Seroxat any longer?

What if long term use of Seroxat could cause problems in later years, despite us stopping the drug?

Not even Glaxo can admit to knowing the answer to that folks - they haven't done any long term study.

I'd love to be able to have access to records that Glaxo have kept away from the public. I hope the disclosure they have provided UK solicitors for the up and coming UK Seroxat Group Action will open many doors - I hope that those doors won't be sealed.

If long term use of Seroxat has caused my frequent bouts of gout then I'd like to know one way or the other because I don't intend in swallowing toxic pills for the rest of my life!

Nothing quite says "I've got explosive diarrhoea" like sitting on the toilet with your shirt around your nipples.

I'd ask for some input from the MHRA on this issue but I don't want to waste my time waiting weeks for the obligatory, "The question whether paroxetine can cause gout is not as straight forward as it may seem..." type of answer.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Return of the Dreaded Gout

Image: billcasselman.com

Sometime last month I went to see my doctor...my new doctor, as I had a bad case of gout flare up in my big toe on my right foot. Treatment with Indomethicin, tablets I had left from my previous attack, proved futile - it just wouldn't shift. So, my new doc, new because my old doctor's surgery is about 15 miles away, prescribed me Colchicine.

A new regimen was started. I have cut out butter, opting for pro-active Flora, cut out full fat milk, opting instead for the semi-skimmed variety. I drink alcohol once every two weeks, when my dad comes to see me, I have about 5 cans of beer.

Alas, despite this strict regimen, the gout returned with a vengeance last Saturday. This time, in my left foot, this time in not just the bog toe, it attacked three toes plus my ankle.

I assumed it would be okay to ride the storm until Monday as my doctor's surgery is only open Monday to Friday. The pain became really unbearable Sunday evening, so bad that I even considered phoning an ambulance.

Luckily, my neighbour was on hand to drive me to casualty. On arrival the place was full of couples with babies, young men suffering from too much booze and many who seemed to have been sitting in the sun for too long. The obligatory tracksuit wearing couples were outside the entrance smoking and complaining to third parties down their mobiles phones.

"There's a wait of about 4 hours", I was told. "But you could just visit the walk-in clinic where you will be assessed and prescribed medication", the desk clerk added.

So, off I went. Within an hour I was seen to and prescribed Colchicine, a pretty toxic drug that is usually prescribed in small doses [because of the toxicity]

I asked [no, told] the locum to give me more pills [I think I only had between 10-12 on my last prescription. He gave me 50.

As soon as I arrived home I started the course. It's not been 48 hours yet but the throbbing pain has subsided a little. I still cannot put a shoe on as that has me screaming like a small girl at a Bay City Rollers concert.

Not much is known about gout, it's all theory - eat this, don't eat that, drink this, don't drink that.

This is my worst attack by far - Gout is something I never used to get before I took Seroxat. I've been Seroxat free for roughly 4 years [I think] so I don't think my attacks can be attributed to Glaxo's wonder drug. I did, however, have my first attack whilst taking Seroxat some years ago.

It feels like you have broken your toe and, at the same time, feels like someone keeps stubbing cigarettes out on the infected area.

It's all to do with the level of uric acid being too high - the acid escapes [overflows] from the liver then finds the nearest joint to settle, uric acid settles in the 'cooler joints' of the body [toes] - once there it crystallises - a close-up of these crystals shows an image like shards of glass.

Ouch.

I'm at a loss as to why I have had this attack as it has come so close to my last attack. I have cut down on high purine intake and have even been drinking plenty of water.

Typical that I should get an attack when we have some of the finest weather we have seen in the UK for years.

Ah well, such is life.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Email to the Japanese Drug Regulator [Re; Paxil Clinical Trial in Japan]

Image: jrenseyblog.files.wordpress.com

Dear Sirs,

As I understand it, you are the drug regulatory authority for Japan, i.e.; the equivalent of the UK drug regulator, the MHRA and the American drug regulator, the FDA.

I would like to bring to your attention a trial currently on-going in Japan. A clinical trial that defies all logic and, I believe, one that is putting the children on it, at risk.

I am referring to the Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study) - Link here - http://clinicaltrials.gov/ct2/show/NCT00812812

I have recently wrote to GlaxoSmithKline to ask them what their motives are behind this current trial - link - http://fiddaman.blogspot.com/2010/05/email-to-glaxosmithkline-re-paxil-study.html

I ask you the same question.

What are the motives behind this trial?

Paroxetine has already been deemed 'unsafe' for children.

The inclusion criteria for this study is even more alarming. Basically the trial has recruited Kids 7-17 yrs who amongst other things, have been diagnosed with major depression and have not exhibited any past suicidal ideation – and have not had drug abuse issues…..etc etc.

The very last exclusion on the list - “Patients in the opinion of the chief investigator (sub-investigator) judged as not eligible for the study”.

In other words, they are loading a study with children who they think will do well. The results will no doubt be favourable.

I am unsure whether or not GlaxoSmithKline have had to seek permission from you to run such a trial in your country, if they have, then why have you granted them permission?

This study should NOT be taking place. By GSK's own admission, "Paroxetine is not approved for the treatment of patients younger than 18 years of age. Please refer to the approved prescribing information for additional warnings and information."

Back in January 2009 I wrote to the Japanese Embassy to alert them of this clinical trial, they never responded. I also wrote to the Japanese Health Minister in April of 2009 - once again, I never received any response from them.

Interestingly only about 1% of the Japanese population are considered poor metabolizers (PM) of 2D6 – but about 60% are considered to be of the intermediate metabolizer type (IM). (Bernard 2006). IMs are slower than the (normal) extensive metabolizer (EM) type and can also suffer severe adverse reactions at lower doses. I wouldn’t put it past GlaxoSmithKline to secretly run 2D6 genotyping and exclude the PM and IM types. After all, the last exclusion criteria (above) seems to be intentionally written vaguely enough to allow them to exclude based on genotype without disclosing that they had performed the test.

I would like an answer to this email in writing.

Interested parties have been blind copied in on this email

Bob Fiddaman


Author of Seroxat Sufferers


Author of the book, The Evidence, However, Is Clear...The Seroxat Scandal

---

RELATED STORIES

Japan/GSK - 329 All Over Again!

Glaxo - Turning Japanese!

Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

GSK Just won't stop trying to push paroxetine on children!

Email to Ministry of Health - Japan

Japan Says Suicidal Cases Rise Among Paxil Users

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

EMAIL TO GLAXOSMITHKLINE RE; PAXIL STUDY IN CHILDREN

Image: artofthestate.co.uk

Dear GSK,

I am writing to you as I am confused regarding an ongoing Paxil [Seroxat] study currently underway from GlaxoSmithKline, Japan.

I refer you to The Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study) - http://clinicaltrials.gov/ct2/show/NCT00812812

As a matter of public record I would like either GlaxoSmithKline UK or GlaxoSmithKline Japan to explain why this study has been put in place. In other words, what is GlaxoSmithKline's motive behind this study?

I am bewildered why GlaxoSmithKline would wish to pursue testing the safety and efficacy of paroxetine in children when you have already deemed that paroxetine is not safe for children.

I strongly object to this clinical trial and I can see no beneficial reason why you are undertaking it. I also fear for those children taking part in the study.

I don't think I need to point you to the Paxil 329 studies, do I?

I am sure that you are aware who I am, your employees and lawyers representing you seem to spend an awful amount of time on my blog.

Regardless, of who I am and what I write about, I would like an answer in writing regarding your motives behind The Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)

I have a genuine concern for the children taking part in this study and also question your motives behind such a program.

Sincerely,

Bob Fiddaman


Author of Seroxat Sufferers

Author of the book, The Evidence, However, Is Clear...The Seroxat Scandal


**Interested parties have been blind copied.

---

A reminder of what we are dealing with here.

Powered by Podbean.com

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Is the Penny Dropping for the FDA? [Avandia]

Image: scrapetv.com

You may recall, a few days ago I wrote about the FDA sanctioning new Avandia trials.

Now, it appears, Glaxo are having trouble recruiting.

The Triangle Business Journal is reporting that Glaxo have confirmed that two 21 research sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have withdrawn from the study because of poor enrollment. William Applegate, dean of Wake Forest’s medical school.

Furthermore, The U.S. Food and Drug Administration [FDA] have also said that it is weighing whether to end the trial early due to the drug’s safety concerns.

Could this just be a penny dropping moment for the FDA?

Image: glaxosmithkline.co.jp

Maybe the Japanese drug regulator should also take a close look at the way GlaxoSmithKline are STILL trying to recruit young children for their Paxil study?

For those that don't know, Paxil [UK name, Seroxat] is not safe for children. It took a good few years before Glaxo acknowledged this - but now, it seems, it could be safe in kids from Japan.

See Glaxo's recruitment criteria for their current Paxil study in children from Japan HERE.

Also note that they won't accept healthy volunteers, thus leaving the door open for "favourable" results.

I'm really surprised there isn't more about this in the mainstream press?

Maybe I'm barking up the wrong tree and Paxil is safe for depressed children?

RELATED STORIES

Japan/GSK - 329 All Over Again!

Glaxo - Turning Japanese!

Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

GSK Just won't stop trying to push paroxetine on children!

Email to Ministry of Health - Japan

Japan Says Suicidal Cases Rise Among Paxil Users

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

DR MYHILL, UK TV, TONIGHT AT 8PM

Sky channel 200 at 8pm tonight.

For those who don't have Sky TV or are outside the UK you can watch it online here:-

http://www.edgemediatv.com/videoplayer/watchonline.html

Back stories:

Is the GMC colluding with GlaxoSmithKline and the psychiatric profession?

The GMC/GLAXO Email

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Cervarix Blogspot - Astroturfing?

The photo's from this post have been removed at the request of the owner, Dr. Wan C. Hung.


I have to be careful here as the images are taken from blogs and I don't want to be accused of copyright theft by GlaxoSmithKline or the person/s behind the blogs I am about to feature.

Firstly, for those of you that are not familiar with the term, 'Astroturfing'

Wikipedia defines it as thus:

"Astroturfing denotes political, advertising, or public relations campaigns that are formally planned by an organization, but are disguised as spontaneous, popular "grassroots" behavior.

The goal of such campaigns is to disguise the efforts of a political or commercial entity as an independent public reaction to some political entity—a politician, political group, product, service or event. Astroturfers attempt to orchestrate the actions of apparently diverse and geographically distributed individuals, by both overt ("outreach", "awareness", etc.) and covert (disinformation) means. Astroturfing may be undertaken by an individual promoting a personal agenda, or highly organized professional groups with money from large corporations, unions, non-profits, or activist organizations. Very often, the efforts are conducted by political consultants who also specialize in opposition research. Beneficiaries are not "grass root" campaigners but distant organizations that orchestrate such campaigns."

So, with this in mind, let me introduce you to the CERVARIX -THE MEDICAL REVOLUTION blog.

The tagline:

"WE ARE PRIVILEGED TO LIVE IN AN ERA TO WITNESS THE DISCOVERY OF A REVOLUTIONARY VACCINE THAT IS FOREVER IMMORTALIZED IN THE HISTORY OF MEDICINE,AND AS A MILESTONE IN THE QUEST BY MANKIND TO CONQUER DISEASES." -DR WAN C.H.

The disclaimer:

This blog is created purely by the author's own initiative with the intention of creating an awareness among the community in matters concerning health and science.

Contents in this blog is based upon the author's own opinion and not being influenced or given remuneration in any form by the manufacturer of the products endorsed by the author.

The contents are written based upon the author's experience, and does not represent the actual fact. The opinion written in the post is deduced by author, and facts derived from medical studies is accompanied with references.

This blog is not created for financial gains, nor serves as an advertisement for the clinic which the author is based.

I do not guarantee any information provided on this site or in the comments, I disclaim any liabilities for any information I carry. Any information you contribute to the site becomes my property. I reserve the right to edit or remove any comments for any reason whatsoever at my discretion. By using this site you agree not to hold me or liable for anything stated within it's pages.

Seems to have covered themselves pretty well.

A post from May 19th caught my attention. It's entitled, "Preparation for Cervical Cancer Prevention Weekend," and kicks off with, "This post is written based upon the author's own initiative, and not being influenced in any way, nor being given any form of remuneration by the pharmaceutical company of which the product is highlighted."

The remainder of the post sees the author tells us how important it is to spread the word about Cervarix. It contains a series of photo's showing the promotional material that GlaxoSmithKline, the manufaturers of the Cervarix vaccine, have sent to the clinic hosting the "Preparation for Cervical Cancer Prevention Weekend."

The blog author goes out on a limb with her first uploaded image - it's almost as if they have been instructed to point out the following message:

"The eye catching posters being provided for by GSK. One should note that no clinic is allowed to advertise the products available, however, this poster did not mention the world Cervarix, merely an eye opener for the public."

The photo's from this post have been removed at the request of the owner, Dr. Wan C. Hung.

Quite impressive huh?

It's at this point that I should inform you that the blog appears to be aimed at citizens of Kuala Lumpur - Although with such an eye-catching url, cervarix.blogspot.com, I think it safe to assume that GlaxoSmithKline have their own free advertising of the controversial vaccine.

The remainder of the post sees various photos of promotional items. The first being a word puzzle. The author writes:

"Word puzzles or patients while waiting for their turn for counseling or vaccination."

The photo's from this post have been removed at the request of the owner, Dr. Wan C. Hung.

One thing that stood out with this promotional item is that there is no mention of Cervarix. But study the picture folks. One cannot help to be drawn to the huge letter X.

It's genius isn't it. Put the word Cervical against a huge letter X, accompany a GSK logo and voila, you have a brilliant subliminal message that, in the eyes of the law, is perfectly innocent and not advertising a brand.

I have said it many times on this blog - GSK have a brilliant advertising team. Only they could advertise a brand...without actually mentioning its name.

There are many more promotional items posted.

Balloons
Badges
Bags
Door hangers
Posters
More bags


All with that huge letter X folks.

The final photo sees a poster advertising the Cervarix Blogspot.

The photo's from this post have been removed at the request of the owner, Dr. Wan C. Hung.

Let's move on now to the author's other blog. This one has the name, BETTER DAYS
ROSE THAT GREW FROM THE CONCRETE - the url is, http://www.hippocrates1976.com

hippocrates1976.com is the intellectual property of the owner, Wan Chee Hung.

The leading post, as of the time of writing, is exactly the same as the leading post on the cervarix.blogspot.com.

Same disclaimer, same promotional photo's - same message.

Wan Chee Hung has this to say about himself:

I did south Australian Matriculation for 9 months before doing my undergraduate program in Bachelor of Medicine and Surgery in India. I served for a year in Manipal, India before coming back to Malaysia in 2001 to serve with our Government Hospital for another 4 years...

...I did further training in Cosmetic and Anti Aging Medicine in Australia. I am a Board Certified Laser Safety Officer registered in the state of Queensland, Australia...

...I am currently a cosmetic and anti aging doctor, who is also a writer, active blogger. I love to challenge my own capability...

The 'BETTER DAYS ROSE THAT GREW FROM THE CONCRETE' blog does feature a vast array of posts where the author blogs about different subjects, unlike the cervarix blog he authors, which was first created in March 2009 and is solely about cerical cancer and Glaxo's vaccine, Cervarix.

However, it should be noted that Wan Chee Hung has a leaning toward GSK products.

This post from the 'BETTER DAYS ROSE THAT GREW FROM THE CONCRETE' blog, entitled, 'Relenza Has Finally Arrived' says it all really:

...Relenza which has a much safety profile compared to Tamiflu has very limited stock due to shortage of stock. Hence before prescribing the medication, customers are subjected to a thorough medical history.

...For those who are traveling overseas, please take note that unlike Vaccine, Relenza provides prophylaxis as long as you continuously consume it.

Manufacturers of Relenza?

GlaxoSmithKline.

Finally, Wan Chee Hung links to the Power Over Cervical Cancer website, a site brought to you by The National Cancer Society of Malaysia.

THE National Cancer Society of Malaysia (NCSM), supported by GlaxoSmithKline Pharma-ceutical (GSK) launched Power Over Cervical Cancer (POCC) campaign in July last year, aimed at educating and creating awareness about cervical cancer.


Sometimes this shit just writes itself.


If I have infringed copyright by including photo's in this post then I shall remove them if contacted by the owner.

My aim, like Wan Chee Hung's, is to bring about awareness regarding GlaxoSmithKline and it's products - although admittedly, I don't promote them as Wan Chee Hung does.

**Update

A reader has spotted this from Wan Chee Hung's website:

http://www.hippocrates1976.com/

"First of all, on behalf of Klinik Wan & Keluarga, we would like to personally thank Miss Wendy from GSK who has been so helpful in furnishing me with updates concerning this vaccine. Her help in providing materials in this campaign has been monumental and instrumental. If it isn't for her help, the campaign wouldn't have materialized."

FOOD FOR THOUGHT

Astroturfing

The goal of such campaigns is to disguise the efforts of a political or commercial entity as an independent public reaction to some political entity—a politician, political group, product, service or event. Astroturfers attempt to orchestrate the actions of apparently diverse and geographically distributed individuals, by both overt ("outreach", "awareness", etc.) and covert (disinformation) means. Astroturfing may be undertaken by an individual promoting a personal agenda, or highly organized professional groups with money from large corporations, unions, non-profits, or activist organizations. Very often, the efforts are conducted by political consultants who also specialize in opposition research. Beneficiaries are not "grass root" campaigners but distant organizations that orchestrate such campaigns. [SOURCE]

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Cervical cancer: Trial and Error

On July 9, 2009, the Andhra Pradesh Minister for Health and Family Welfare in association with the Indian Council of Medical Research (ICMR) and PATH (Programme for Appropriate Technology in Health) International a non-profit organization based in USA launched what it described as a ‘demonstration project’ for vaccination against cervical cancer. The vaccine, against the Human Papillomavirus (HPV), which is one of the most common families of viruses and the source of a common sexually transmitted infection, was administered to 14,000 girls between the ages of 10 and 14 in three mandals – Bhadrachalam, Kothagudem and Thirumalayapalem – of Khammam district in Andhra Pradesh. In Andhra Pradesh, the vaccine used was Gardasil, manufactured by Merck Sharpe and Dohme, the Indian subsidiary of Merck and Co. Inc., a US-based pharmaceutical company. [source]


PART ONE



PART TWO



PART THREE



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

FDA Sanction Diabetes Drug Trial [Avandia]

Image: static.guim.co.uk

So, a drug gets a bad rap - it's allegedly responsible for the death of many thousands. What do the drug regulators do?

Basically, a trial designed to assess the cardiovascular risks associated with the diabetes drug rosiglitazone (AVANDIA) began in May 2009 by GlaxoSmithKline at the request of the FDA. It involves 137 sites in 14 countries, including 19 sites in the U.S. and 34 in Canada. During April 2010, many new sites were added in developing countries, including Chile, Mexico, Colombia, Latvia, Pakistan and India, presumably to compensate for poor enrollment elsewhere. Eighty-three sites are already recruiting subjects for the trial, which has an anticipated sample size of 16,000 subjects and a targeted completion date in 2015.


Read the following letter sent to the FDA from Sidney M. Wolfe, M.D.

It seems we have been down this road before with Seroxat. Remember, Seroxat is banned for use in children. Strange then that GlaxoSmithKline are currently recruiting children for their Paxil NCT00812812 trial

It's a head scratching moment, for me at least.

Here we have two GlaxoSmithKline products in Avandia and Seroxat. Both can be Googled to see how controversial they are - and now both are being tested again in what can only be deemed as a PR spin 'to prove the public wrong.'

It's baffling but hey, it's pharma and they can do as they please regardless of the consequences to the human guinea pigs.

More on the Paxil NCT00812812 trial HERE

And here's what a recent US Congressional hearing had to say about Avandia and the way the FDA handled complaints about it. [LINK]

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

What do medical students think about pharmaceutical promotion?

Image: medindia.net


What do medical students think about pharmaceutical promotion?
By David Carmody & Peter Mansfield

The aim of this review was to produce an overview of surveys of medical students’ exposure to and attitudes towards pharmaceutical promotion.

Methods: PubMed was searched for studies featuring surveys of medical students regarding their interactions with pharmaceutical promotion and tabulated the findings for survey questions relating to the main themes.

Results: Students have significant exposure to promotion, and they generally view receiving gifts as acceptable, but do regard some gifts as more appropriate than others. Most students think pharmaceutical sales representative (PSR) presentations are biased but still of educational value and should not be banned. Most students do not believe promotion will affect their prescribing behaviours. A large majority of students want more education in their curricula on how to interact with PSRs.

Conclusions: Many medical students think that pharmaceutical promotion is biased and feel underprepared for interactions with the pharmaceutical industry. Despite this, they accept exposure to pharmaceutical promotion believing that it will not influence them. There is scope for improved education in medical schools about this issue.

FULL PAPER HERE

Ed Silverman of Pharmalot has also featured this paper - HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

MHRA ISSUE WARNING: SSRIs and SNRIs: Risk of persistent pulmonary hypertension in the newborn

Is this one of them moments where a patient can turn around to the MHRA and say, "I told you so."?

Much of my correspondence with the MHRA, indeed with their CEO, Kent Woods, regarding Seroxat being a teratogen is in my book, The Evidence, However, Is Clear...The Seroxat Scandal.

At the time of writing the book, the MHRA were fence sitting but this months safety update from the MHRA sees a crystal clear message.

They write:

Advice for healthcare professionals:

• Healthcare professionals, including midwives, should be aware of the increased risk of PPHN associated with all SSRIs and potentially with SNRIs. The observed increase in risk is about an extra 3–4 cases of PPHN per 1000 pregnancies.

• In light of these new data, healthcare professionals are encouraged to enquire about the use of these medicines, particularly in women in the later stages of pregnancy.

• Close observation of neonates exposed to SSRIs or SNRIs for signs of PPHN is recommended after birth.

There is still no mention of these drugs being teratogenic?

Regular readers of this blog will know that for some time I was liaising with the MHRA almost on a daily basis. The issue of whether Seroxat is a teratogen was the straw that broke the camels back and I refused to speak with them after receiving an answer [of sorts] from them regarding the Seroxat/Teratogen affair.

On the 5th of November, 2009 I sent an email to Sarah Morgan, Head of Pharmacovigilance Risk Management, at the MHRA. I also copied in Simon Gregor, Director of Communications at the MHRA. The question was short and sweet, Is paroxetine a teratogen?

Chapter 18 of my book highlights all the correspondence between myself and the MHRA. I'd even wrote to GlaxoSmithKline, the National Poisons Information Service [NPIS] and Yellow Card Centre Northern and Yorkshire Regional Drug and Therapeutics Centre. Between all four of them, not one could give me a straight answer.

The NPIS wrote:

"I am afraid we do not take enquiries from the public. If you are pregnant or thinking of becoming pregnant and are on paroxetine then talk to your GP or midwife who will advise you."

The Yellow Card Centre Northern and Yorkshire Regional Drug and Therapeutics Centre also fence sat with:

"Unfortunately here at the Yellow Card Centre Northern and Yorkshire we do not handle teratology enquiries. There is a dedicated teratology line for health professionals only listed in the BNF. Should you be a member of the public I suggest you make an appointment to discuss this with your GP."

GlaxoSmithKline refused to answer the question directly because I was not a health care professional. They wrote:

"GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide patients with advice about medicines which are available on prescription because any advice we might give could conflict with that of your own doctor who is in a far better position to advise you. Therefore, to enable GSK to provide you with the most relevant information please can you confirm if you are a health care professional."

The MHRA wrote me [eventually].

The opening paragraph sets the tone for the three page answer!

"The question “Is paroxetine a teratogen?” is not as straight forward as it may appear."

The three page answer along with my replies to them and further correspondence with their CEO, Kent Woods is all in my book.

I still stand by my decision not to correspond with the MHRA any more.

The recent MHRA update kinda proves how fickle they are.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

GSK's Titty Tantrum Over Cafe Pharma

Have Glaxo shot themselves in the foot?
Image: willohroots.files.wordpress.com


It's not often I laugh at the tactics of GSK but this latest had me biting the leg of my table - I was in a state of complete apoplexy upon reading Ed Silverman's article,
Glaxo Blocks Employee Access To CafePharma.

It appears Glaxo don't like what is being said on the boards at Cafe Pharma, so, just like big powerful multi-billionaires do, they block access to the website.

I have, in the past, posted various threads from the Cafe Pharma forum - much is posted anonymously so it's difficult to ascertain whether or not the posts are genuine. However, there are some posts of real quality on there and it's obvious to all and sundry that there are many disgruntled employees working for GlaxoSmithKline.

I find this latest move by GSK totally baffling. Their PR Department must have handed its reigns over to some kid on a youth opportunities employment programme or something.

If you want to get the backs up of those you employ then try and suppress them.

This is one almighty clanger dropped by GSK - Did they not foresee this?

I'm glad they didn't because now we can all have a good laugh at their expense.

Here's a thread from Cafe Pharma that is comic genius. [Cafepharma access Blocked at GSK]

I can just picture it now:

GSK employee has bad day.

Decides to post on Cafe Pharma.

Learns that access has been blocked.



Goes home later that evening and spills the beans on GSK.

Genius PR from Glaxo!


Memo to the guys and gals over at the GSK Cafe Pharma Forum:

COME VISIT MY BLOG - MY COMMENT SECTION IS ALWAYS OPEN FOR DEBATE.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Misleading Drug Promotions? They've being Doing It For Years!

Well, it appears the FDA are on some sort of mission, 'appears' being the operative word here as they, like the MHRA, often talk the talk but rarely walk the walk.

The FDA announced earlier this week that they were cracking down on misleading or inaccurate promotion of prescription medications, apparently designed to educate health care professionals so that physicians and others can help the agency.

They have eyes don't they?

The FDA'S 'Bad Ad Program' have even designed a brochure for us all to download. My lack of faith in medicine regulators sees this as a 'cover ourselves in garlands' exercise.

I have to laugh at this, particularly as last year I highlighted on my blog that the UK regulator, the MHRA, had teamed up with pharma giant's Pfizer to launch a series of ad-campaigns throughout UK cinema's.

Here's their second ad



Pretty strong stuff, eh?

The message is quite clear. Don't buy your drugs off the Internet because they are probably fake. In other words, Pfizer's Viagra is losing sales due to people selling different versions of them online.

Of course, the MHRA would take a different stance, spouting that Internet sales of fake pharmaceutical products is a big problem. It probably is... but not half as big as the problem of consumers struggling with severe side-effects of the drugs they have popped that have been manufactured by the 'industry'.

The MHRA followed up with a poster and website campaign. Once again Pfizer were on board to help promote this campaign.

Here's one of the posters from their website, REALDANGER. Get Real, Get a Prescription™



I can't really claim that the above ad is misleading but it's just an example of the regulator working with the industry rather than with the patient.



Here's an ad that aired in the UK last year - remember, prescription medication is not allowed promotion on British TV.

I found the ad misleading:

"40% of men over 40 may have suffered some degree of erectile dysfunction," says the voiceover. This claim is then juxtaposed with a pop-up subtitle that states: "12 year study of US males. The Massachusetts Male Aging Study 1994."

Firstly, why is an ad airing on British TV using data that refers to American men and secondly, why are they using a study to back up their claim that is 15 years old?


The ad promotes the website 40over40.com, a website sponsored by Eli Lilly and Company.

I pondered complaining to the MHRA but it seems they have already received a complaint about this particular ad, a complaint that they did not uphold!

** Prohibition of advertisements for medicinal products on prescription only

7. Subject to regulation 11, no person shall issue an advertisement which is likely to lead to the use of a relevant medicinal product which is a medicinal product for supply by prescription only and which is subject to any of the restrictions imposed by section 58(2) of the Act.

Source: The Medicines (Advertising) Regulations 1994

So, if the FDA are really serious about misleading drug promotions, they, like the MHRA, need to get their own house in order first.

Here's a few ads the where the FDA previously buried their heads in the sand.

See if you can spot the deliberate flaws.

[Ad for Paxil 1999] [Back story]


Here's a Paxil ad from the year 2000



...more of the same from 2002



There are many more to view on youtube.com [Paxil Ad Search]

The FDA's new "Bad Ad Program" aims to ensure that promotional information is accurate, balances the risks and benefits of a product, is consistent with prescribing information approved by the FDA, and includes only information that is supported by strong evidence from clinical studies.

I'd write more about this but my concentration has just been broken by a pig flying past my window!

Fid



PAPERBACK COMING SOON.

PROMOTIONAL VIDEO HERE

Book: The Goose That Laid the Golden Egg by Doug Bremner

I remember when I first came across the name, 'Doug Bremner', I thought he was just another shill from Emory, a University that has provided us with so many pharma whores down the years.

I was wrong.

Doug and I have corresponded many times over the last 12 months or so, he has even offered me advice regarding my book.

He's one of the good guys.

Doug is now in the process of promoting his new book, 'THE GOOSE THAT LAID THE GOLDEN EGG: A Pharmaceutical Industry Morality Tale'

Here's the blurb:

Described by one reader as "Erin Brockovich meets 'The Constant Gardener,'" the work tells the story of Professor Doug Bremner, a researcher and psychiatrist who blew the whistle on the dangers of Accutane, a prescription medication for the treatment of acne that produces toxic side effects causing depression and resulting in numerous suicides. As a result, he got chewed up and spit out by Roche Pharmaceuticals of Nutley, NJ, the company that earned a billion dollars a year from marketing this drug. Bremner describes his struggles with the drug company and the toll they took on his career, marriage and family. The book reads like a thriller because Bremner's narrative involves greed, power, lust, lies, tragedy, danger and death.

Drawn into the medication controversy as an unwilling participant, Bremner learns that he must confront the lies and deception in his own life before he can confront those of others. Thus, a second thread involves the sudden death of Bremner's mother when he was four and a half years old. With nothing to lose, he embarks on a journey to uncover the truth about his mother. He must overcome 40 years of lies and distortion about facts related to her death. Eventually, he locates his mother's ashes, and he and his siblings buy a tombstone and have a ceremony where they place it over their mother's burial site in Olympia, Washington.

With legal battles turning against it as well as dwindling sales resulting from the growing awareness of the dangers of the drug, Roche withdraws Accutane from the market in June 2009, thus providing Bremner's ultimate vindication.
Overall, the book reveals the inner workings of a large network of interrelated, profit-driven healthcare institutions, which include drug companies, hospitals, doctors, the FDA and the infrastructure that supports medical research and academic medicine. It is about the struggle between greed and power and truth and justice, one that affects us all

.

Doug is currently professor of psychiatry and radiology, Doug Bremner, MD, is also director of the Emory Clinical Neuroscience Research Unit at Emory University School of Medicine and is director of mental health research at the Atlanta VA Medical Center. He is the author of BEFORE YOU TAKE THAT PILL: Why the Drug Industry May Be Bad for Your Health (Avery, 2008).

I have to take my hat off to professionals who are willing to put their careers on the line. I'm merely a blogger so am basically not restricted with my opinions. Doug and people like him have much more to lose when they blow the whistle against the darker side of pharmaceutical drugs.

I salute you Doug.

Doug's blog, Before You Take That Pill, can be read HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia

Image: static.guim.co.uk


GlaxoSmithKline's Avandia and the way the FDA handled complaints about it have been highlighted at a recent US Congressional hearing.

The report, by Sens Max Baucus and Charles Grassley, concluded that there are "serious health risks associated with Avandia."

Subcommittee chair Rep Rosa DeLauro said: "This report poses several troubling questions for this subcommittee. Most obviously, if Avandia is unsafe, how did it ever get on the market in the first place? For that matter, why is it still on the market, right now? And what does the case of Avandia tell us about the FDA's current ability to conduct its drug safety responsibilities?".

Grassley, Dr Harlan Krumholz [Yale University School of Medicine], and Dr Sidney Wolfe [Public Citizen] told the congressional hearing that the system allows companies to suppress negative clinical data on their drugs.

Summing up Grassley told the hearing that GlaxoSmithKline knew years before Nissen's meta-analysis was published that rosiglitazone [Avandia] may increase the risk of Myocardial infarction, commonly known as a heart attack, but suppressed that information and that safety experts at the FDA had also expressed concerns about the drug, but these were ignored by the leaders at the agency.

GlaxoSmithKline responds

GlaxoSmithKline issued a statement reiterating points the company has made repeatedly in the past, emphasizing that the best evidence to date comes from RECORD, which showed no safety issues with Avandia, and that judgment should be reserved until the FDA-directed TIDE trial has been completed and analyzed.

"In the years since the FDA convened the joint advisory committee meeting to address questions about the cardiovascular safety of Avandia, six large, prospective, randomized, clinical trials have reported results. None of these randomized clinical trials . . . shows a statistically significant association between Avandia and myocardial infarction or other ischemic cardiovascular events," the statement reads.

GlaxoSmithKline also rejects suggestions made in the February Senate report that the company failed to present an accurate, balanced, or complete view of the currently available information on Avandia. "A fair examination of the company's record will show that GlaxoSmithKline has been diligent in its efforts to thoroughly study the safety and effectiveness of rosiglitazone and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians, and others in a variety of ways," it says

.

Déjà vu anyone?


Full damning report can now be downloaded HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Brace Yourselves GSK - Possible $1bn in Avandia Settlements

Yet more money thrown at a problem. No criminal charges just dollars, gagging orders and no admission of liability.

The Financial Times is today reporting that GlaxoSmithKline may have to pay up to $1Billion [£670Million] to settle side-effect claims on its diabetes medicine Avandia.

The Financial Times writes:

The pharmaceutical company is close to finalising an out-of-court deal for about $60m with a group of 700 plaintiffs who claim the drug caused strokes and heart attacks

.

Adding:

GSK has never disclosed the number of lawsuits it faces concerning Avandia, and refused to comment yesterday on the settlement.

I find it strange that they have 'refused to comment,' I'm kind of missing the normal, "Avandia has helped millions of people world-wide" type of comment from one of their spokespersons.

Both GlaxoSmithKline and the US drug regulators, the FDA, were criticised in a Senate report for their handling of Avandia earlier this year.

FULL STORY


Staying on-topic, GlaxoSmithKline are heading for the High Court in London later this year to defend their drug Seroxat, known as Paxil in the US.

GlaxoSmithKline are defending claims that Seroxat has propensity to cause withdrawal reactions.

Glaxo have reportedly already paid out almost $1Billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993. [Source]

Last year GlaxoSmithKline were found guilty by a majority of 10-2 that Seroxat caused a child, Lyam Kilker, to be born with heart defects. At the time there were a further 630 or so other cases pending. Glaxo, it appears, have been quietly settling these cases out of court.



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Leaders On Thin Ice - The Cameron - Clegg Dance

Personalize funny videos and birthday eCards at JibJab!

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

June 4, 2007 - The FDA, GlaxoSmithKline and the Avandia Disaster

Image: static.guim.co.uk

Following on from today's announcement on Bloomberg regarding GlaxoSmithKline making out of court settlements re their drug, Avandia.

Here is an article written by investigative journalist, Evelyn Pringle.

Evie penned this in 2007.

I think it's about high time that this suppression and obvious denial, stops, right here, right now.

If there is one thing in life I must do, it is to meet Evelyn Pringle so I can kneel down before her uttering, "We are not worthy" - This woman deserves a Pulitzer for uncovering the dodgy goings-on within the pharmaceutical industry and the supposed drug regulators.

Evie, this blog salutes you.

June 4, 2007

Partners in Crime

The FDA, GlaxoSmithKline and the Avandia Disaster

By EVELYN PRINGLE

On May 21, 2007, the New England Journal of Medicine reported a study that found GlaxoSmithKline's diabetes drug Avandia is associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death. The NEJM said it posted the article online ahead of its June 6, 2007 print edition because of its medical importance.

Experts point out that the studies analyzed for the NEJM report were not designed to look for heart risks, many were only 24 weeks long, and it may be that higher risks will appear after a longer term of use. Dr David Nathan, chief of diabetes care at Massachusetts General Hospital, who reviewed the paper for the NEJM, told the Associated Press, "This analysis is just scratching the surface of what may be there."

Avandia (rosiglitazone) was FDA approved in 1999 for the treatment of type 2 diabetes, a disease that affects between 18 to 20 million Americans.

When approved, Glaxo promoted Avandia as being safer than Rezulin, a diabetes drug removed from the market in 2000 after serious cases of liver damage developed in patients taking the drug.

Avandia is currently the top selling diabetes drug with total US sales of $2.2 billion in 2006, according to IMS Health, a healthcare tracking information firm. A one-month supply sells for between $90 and $170, the Associated Press reported on May 23, 2007.

"More than 6 million people worldwide," the Associated Press reports, "have taken the drug to control blood sugar since it came on the market eight years ago, and about 1 million Americans use it now."

The FDA is going to have an extremely tough time wiggling out from under the rug of blame for this regulatory failure. The situation "reflects very badly on the FDA and on Glaxo," Dr Nathan said. "It's the FDA's responsibility to be monitoring this stuff."

In an editorial that accompanied the study in the NEJM, Dr Bruce Psaty of the University of Washington and Dr Furberg of Wake Forest University wrote: The drug "represents a major failure of the drug-use and drug-approval processes in the United States."

They also state that "the rationale for prescribing rosiglitazone at this time is unclear," because when the drug was approved its benefits were "at best mixed."

Documents dating back 7 years show the FDA knew about the risks associated with Avandia and did nothing to protect consumers. The day after the new study appeared online, on May 23, 2007, Dr Sidney Wolfe, director of Public Citizen, a non-profit health research group, sent a letter to FDA Commissioner Andrew von Eschenbach, which described a July 16, 2002 FDA memo that showed FDA scientists had recommended that the label for Avandia be amended to include post-marketing reports of heart failure among patients taking the drug.

"The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough," Dr Wolfe said in a press release.

"As a result," he stated further, "millions of people -- to the detriment of their health -- are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs."

According to the memo, in July 2002, the FDA had 25 adverse reaction reports in which the use of Avandia resulted in hospitalization for heart failure. By the fall of 2006, the number of cases had increased to 415, Public Citizen reports.

Another memo dated May 22, 2002, submitted to the FDA by Dr. Wolfe and Larry Sasich for an FDA Hearing on Risk Management of Prescription Drugs informed the panel that a Glaxo-employed physician had contacted Public Citizen to report that the company was concealing reports of serious problems found with the drug.

"This week," they informed the FDA, "we received an anonymous call from a GlaxoSmithKline physician who was alarmed at the failure of his company to require a black box warning concerning heart failure caused by Avandia."

"He maintained that the company currently has 450 reports of heart failure associated with the use of the drug and over 1200 reports of edema," the statement said.

Nearly two years earlier, on March 15, 2000, Dr. John Buse, an Associate Professor of Medicine and Director of a Diabetes Care Center in Durham, North Carolina, sent a letter to then FDA Commissioner, Dr Jane Henney, warning the FDA about the risks of Avandia and describing the abuse of clinical trial data by Glaxo.

"I remain concerned about the safety of rosiglitazone," Dr Buse wrote, "in light of its consistent negative impact on lipids documented in the FDA registration data as well as a worrisome trend in cardiovascular deaths and severe adverse events in the subjects exposed to rosiglitazone versus active comparators."

Dr Buse warned, "I think the FDA has to act forcefully to prevent the rampant abuse of clinical trial data by SmithKline Beecham."

He warned Dr Henney that Glaxo was overstating the safety of Avandia with respect to cardiovascular issues. "I have been shown glossy materials claiming that rosiglitazone has been uniquely studied in patients with preexisting cardiac disease," he wrote, "including patients with a number of associated conditions (such as unstable angina)."

"I know for a fact," he noted, "that such patients are excluded in clinical trials as I am a PI [Principal Investigator] in one of their trials."

Lawmakers in both Houses of Congress reacted to the news of another FDA regulatory failure immediately. On May 21, 2007 the US House of Representatives Committee on Oversight and Government Reform announced that a hearing would be held on June 6, 2007, at 10:00 am in Room 2154, Rayburn House Office Building, to assess the FDA's role in the evaluation of the safety of Avandia.

Committee chairman, Rep Henry Waxman (D-CA) extended an invitation to the author of the NEJM article, cardiologist, Dr Steven Nissen of the Cleveland Clinic, to testify at the hearing and discuss his article.

Dr Nissen and statistician Kathy Wolski, MPH, evaluated 42 studies involving nearly 28,000 patients and compared the 15,560 patients who were using Avandia to the patients who were not using the drug. The study found there were 86 myocardial infarctions in the Avandia group and 72 in the control group and there were 39 deaths from cardiovascular causes in Avandia patients compared to 22 in the control group.

Rep Waxman also sent a letter to FDA Commissioner Andrew von Eschenbach requesting his testimony at the hearing. In addition, he instructed the Commissioner to provide the Committee with specific information from August 1, 2005, to the present to include: (1) A chronology of actions taken by FDA in relation to the cardiovascular safety of rosiglitazone; (2) All communications between GlaxoSmithKline and the FDA relating to cardiovascular safety of rosiglitazone; and (3) All internal FDA analyses, slide presentations, and memoranda relating to the cardiovascular safety of rosiglitazone.

"In complying with this request," Rep Waxman advised the Commissioner, "you should produce all responsive documents in your possession, custody, or control."

Rep Waxman also told the Commissioner, "you should submit a written certification, signed by you or your counsel, stating that: (1) a diligent search has been completed of all documents in your possession, custody, or control which reasonably could contain responsive documents: and (2) all documents located during the search that are responsive have been produced to the Committee or identified in a privilege log."

And last but not least, Rep Waxman sent a letter to Glaxo CEO, Dr Jean-Pierre Garnier, asking him to appear. "We request that you come prepared to discuss your company's actions with regard to the cardiovascular safety of Avandia," the letter states.

Over in the US Senate, Senators Max Baucus and Chuck Grassley, Chairman and Ranking Member of the Senate Committee on Finance, which has jurisdiction over the Medicare and Medicaid programs, issued a public statement and sent letters to the FDA and Glaxo demanding they provide specific documents and other information to the Committee.

"What we are learning about the handling of Avandia," Sen Baucus said in the statement, "by both GlaxoSmithKline and the FDA is appalling and unacceptable."

"Both the drug company and the FDA," he said, "have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn't take immediate action to protect patients."

"We need to know if this is another Vioxx," Senator Grassley stated, "where the FDA sat on its hands and endangered lives."

"The FDA," he continued, "has talked a good game about how it's beefed up post-market
surveillance over the last two years, but a case like this undermines that claim."

Experts say the new study findings are alarming because two-thirds of the people with type 2 diabetes die of heart problems. In a May 21, 2007 letter to Christopher Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline, Senators Baucus and Grassley wrote, "It is troubling, to say the least, that by taking Avandia, diabetics may be increasing their risk of the very adverse event that they hope to prevent by controlling their blood sugar."

"To make matters worse," they advised, "American taxpayers have spent hundreds of millions of dollars on this drug through the Medicare and Medicaid programs."

"One of the most immediate concerns to us," they told Mr Viehbacher, "are reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia."

"This allegation is very serious and warrants further investigation," the Senators wrote.

According to plaintiffs attorney, Karen Barth Menzies of Baum Hedlund, a law firm that has been litigating drug related cases against Glaxo since 2001, "The relationship between FDA and the drug industry is disturbing. We've seen internal correspondence between GSK and the FDA that would cause anyone to question the objectivity and regulatory effectiveness of the FDA. Apparently the FDA has failed yet again to protect the public - to the benefit of pharmaceutical industry profits. This failure, and FDA's derogatory attitude towards Dr. Nissen's study, should sound an alarm to all healthcare providers, patients and legislators that the problem is systemic. Patient safety commands serious change in the agency and the industry."

Already, legal conferences are being scheduled to discuss the legal implications of this latest drug safety scandal. Karen Barth Menzies is an invited speaker at an upcoming legal conference regarding Avandia. The conference will include Avandia's background, the science behind the drug, its side effects as well as the FDA's role in regulating Avandia.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING