Back In The Frame : Avandia Gets Pulled By Europe


Hey Folks, yes, I know I said I wasn’t going to be blogging for a while, but I just couldn’t believe the news just in..

Glaxosmithkline’s Avandia has been pulled by the European regulators! Can you believe it? I can’t, but it’s true. I wonder why Seroxat was never pulled though? It caused just as much damage, damage such as : birth defects, suicide, homicide, severe withdrawal and a host of other problems. Yet the regulator let GSK away with it, why is that I wonder? Surely if they had pulled Seroxat and really taught GSK a lesson in ethical behavior then the Avandia catastrophe would never have happened? A little too late once again perhaps?… hmmmm…. Food for thought indeed..

…. that said, I really must commend and applaud Shelley Jofre and the Panorama team, in fairness, they did try to change things with their 4 documentaries on Seroxat (yes 4 documentaries!!) and I must applaud them again for highlighting Avanda and its dangers. Also a big shout out to Bob Fiddaman, all the lone bloggers and patient advocates out there, and also of course to Seroxat Secrets. You’re all doing a great service guys. Well done.

For more on this, check out Bob Fiddaman’s new post on his blog :

http://fiddaman.blogspot.com/2010/09/gsks-avandia-is-toast-in-europe-only.html

On a completely different topic (and this will definitely be my last blog post for a while) I just wanted to show my readers the kinds of word searches that have been used lately for people to come upon my blog, quite interesting I think. It’s a just a mere fraction of the search hits but it just goes to show the power of google and social media, catch y’all soon! Be good. 🙂

avandia

mhra testing licensing scandal seroxat

irish medical times/avandia

newspaper article on drug

seroxat

irish medicines board/avandia

is seroxat still on the market

sky news avandia 23 sep 2

psychiatry

avandia breckenridge

pharmaceutical representative offers

gsk avandia

seroxat fraud charges in the us

how many people did avandia kill?

newspaper articles on suicide

what the benefits of glaxosmithkline

Exiting Blog Land For A While : Later Folks


It’s that time of year folks when I have to hang up my blogging cap for a while and concentrate on other stuff in my life, but I will be back soon. I just wanted to thank all those who have read my posts and also those who have contributed to the discourse about SSRI drugs over the Summer. If you need to catch up on all the latest Seroxat/Paxil related news please check out Bob Fiddaman’s rich and resourceful blog ‘Seroxat Sufferers’ for regular updates, discussion and news. If you are looking for more information out there about SSRI drugs/Psychiatry and the pharmaceutical industry, ‘Google’ to your hearts content, there’s a multitude of blogs and websites now, and I hope that this discussion continues as the web expands. I wish you all well, and have a nice Autumn, wherever and whoever you are! Thanks .

Bob’s Seroxat Blog

http://fiddaman.blogspot.com/#

Perilous Pill Pushing : Avandia And GSK


http://www.ft.com/cms/s/0/5cc9d62e-c5b5-11df-ab48-00144feab49a.html

Pharmaceuticals: Perils for pill pushers

By Andrew Jack
Published: September 21 2010 21:32 | Last updated: September 21 2010 21:32

When the US Food and Drug Administration presented an award last week to honour the 96-year-old Frances Kelsey, a former employee who helped save America from thalidomide, the mood in the agency’s corridors was not purely one of celebration.

Back in the 1960s, her actions blocked US approval of the morning sickness pill that caused thousands of children in Europe to be born with birth defects. Yet 50 years later, in the agency in Washington and at its counterpart in London, the European Medicines Agency, officials still fret over such life-and-death decisions.

In the coming days, they must choose whether to withdraw from the market GlaxoSmithKline’s top-selling Avandia diabetes drug, just one of a number of recent “blockbuster” medicines that have been subject to intensifying – and fiercely divergent – opinions over safety.

Critics such as Steven Nissen, a cardiologist at the Cleveland Clinic in the US who three years ago helped stoke public and political concern – and a sharp drop in prescriptions – by suggesting that the medicine triggered heart attacks, says: “Avandia is the worst drug safety catastrophe in our lifetime. It’s really a mess.”

To others, the regulators have done an increasingly effective job over the years in protecting patients, but are coming under growing pressure to gather and release ever greater amounts of data. Hans-Georg Eichler, senior medical officer at the EMA, says: “We are scrutinising drugs far more thoroughly than 10 or 20 years ago. I would like to think we have become much better at approving safer and more effective drugs.”

Squeezed in the middle is the pharmaceutical industry, the engine of drug development, which is seeing its business model put under severe strain by costly new requirements, pressures on pricing and the limitations of scientific progress.

STANDARD PRACTICE

Increasingly working with their foreign counterparts and in ever earlier consultation with pharmaceutical companies, regulators set standards for safety and efficacy for new drugs, authorise clinical trials to test them against and decide whether they meet the thresholds for approval.

They continue to process data on side effects, and weigh the risks and benefits, withdrawing drugs or changing authorised uses. Doctors may prescribe beyond these uses.

Thalidomide marked a turning point in the history of drug regulation, leading authorities around the world to impose higher approval standards to ensure drugs were tested for safety as well as efficacy.

A more recent landmark came in 2004, when Merck of the US withdrew its blockbuster painkiller Vioxx after concerns that it was causing heart attacks in patients. That heralded a fresh period of political criticism of – and introspection among – regulators. The result has been a more cautious “safety first” approach that has further raised the bar for approval.

Vioxx was highly effective in treating pain in some patients and avoided the stomach bleeding associated with the previous generation of drugs. Critics claim data on the drug’s side effects were played down, while aggressive marketing led to its inappropriate use in many for whom the risks outweighed the benefits.

GlaxoSmithKline’s handling of Avandia – also known by the generic name rosiglitazone – has many of the same elements. Launched in 2000 as a drug designed to help control diabetes, by 2006 was generating more than $3bn in annual sales. But data began emerging suggesting that it could also be contributing to cardiovascular problems including heart attacks.

A US Senate inquiry concluded in January: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimise or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

A series of articles in the British Medical Journal this month reviewing the history of Avandia led its editor to suggest that the drug “should never have been licensed”. The BMJ called for a substantial weakening of the pharmaceuticals industry’s control over clinical trials. Some experts questioned both the short duration of the trials undertaken by GSK and the use of “surrogate end-points” based on blood tests to evaluate its effect on diabetes, rather than “hard end-points” such as whether it extended life or caused coronaries.

The drug was approved, although the EMA also required GSK to begin a longer-term trial measuring its cardiovascular effects. The study, called Record, was lambasted at a hearing this summer by Thomas Marciniak, an FDA official, who listed weaknesses in its design and implementation, and claimed his agency would never have authorised it.

GSK maintains it has always fully co-operated with the regulators on the growing number of studies it ran; that there are flaws in the studies that criticised Avandia, some conducted by researchers working with Japan’s Takeda Pharmaceutical on its rival Actos treatment; and that the results of the best-constructed and most relevant clinical trials still show no greater risk of serious cardiovascular problems than among diabetics on other therapies.

In balancing the evidence, one difficulty is untangling the different “confounding” factors that may have caused the cardiovascular problems identified in patients. “Diabetes itself increases coronary heart disease,” says one regulator, arguing that the case against Avandia is not easy to make. As with Vioxx, many people have multiple medical conditions and take a range of drugs.

A second problem is the uncertainty of rapidly evolving scientific understanding. Today, with more knowledge of the risk that Avandia and similar drugs may cause cardiovascular problems, there is greater – though still far from unanimous – agreement on what clinical studies should measure. A decade ago, that consensus was less well established. Even if longer and more detailed studies could have provided clearer answers then, they would also have required more time.

Subsequent advances in understanding can also make new studies difficult. Critics argue that the risk of cardiovascular problems with Avandia make it unethical even to compare the drug against Actos in patients. As a result, the FDA has suspended a trial designed to do that.

ACCELERATED APPROVALS

‘When practised in the public eye, medicine can be messy’

If Avandia, GlaxoSmithKline’s controversial diabetes drug, is largely the product of the regulatory system of a decade ago, a cancer medicine called Avastin is a symbol of more recent fine-tuning by authorities.

Avastin, developed by Genentech, Roche’s now wholly owned US subsidiary, is a lucrative blockbuster. Its possible withdrawal from the market as a treatment for advanced breast cancer (though not for other cancers), mooted this week but deferred until December, would cause sales to drop. Its problems have depressed the Swiss pharmaceutical group’s share price.

There, however, the similarities end. Avandia is a chemical-based drug that has racked up 14m patient years in use over the past decade, designed to slow the progression of diabetes. Avastin is a much more expensive biological drug given to far fewer patients, aimed at pushing back what would otherwise be imminent death.

Where Avandia was granted approval with a relatively wide range of uses in diabetes following large-scale clinical trials – however imperfect – Avastin was granted “accelerated approval” in spite of scientific dissent. That clearance carried the explicit condition that that decision would be reviewed once its effect in additional patients had been analysed in further studies.

These further data – the Ribbon-1 and Avado trials – have shown that Avastin in metastatic breast cancer does not extend patients’ survival, probably because the drug’s ability to prevent the tumour growing was offset by its toxicity, causing bleeding and heart failure. Many observers expect it to be withdrawn as a result.

“Avastin in breast cancer is rapidly becoming a classic case study of how messy science-based medicine can be when practised in the public eye and debated among pharmaceutical companies, the government and patient advocacy groups,” David Gorski, an oncologist and blogger, wrote recently.

Some now suggest that Avastin – like Herceptin, Roche’s other breast cancer drug – should be studied to see if it would work only if given to a subgroup of patients with a suitable genetic make-up. The problem is that such research is costly and uncertain: few drugs yet have such clear genetic markers in place.

More rapid approvals where the benefits of a new drug are strong – coupled with tough follow-up testing and a curb on excessive marketing – can meanwhile help. One danger is a reluctance to withdraw the drug subsequently even if data are weak.

Another is that this course defies the traditional mass-market approach to drug pricing. Offering it to far fewer people would cut revenues, unless its efficacy in a smaller subpopulation is sufficient to persuade healthcare systems to pay that much more for it.

Ray Hill, president of the British Pharmacological Society and a former Merck executive, says running more and longer studies comes at the expense of slower access by patients to more effective new treatments. “I still have nightmares that we may have made a mistake in withdrawing Vioxx,” he says, citing examples of patients with arthritis and other painful conditions for whom the drug was the most effective treatment but who now have to seek inferior alternatives.

He also cautions that the much higher cost of longer and larger trials risks reducing pharmaceutical research and stunting innovation. For example, the entire class of Cox 2 painkillers, of which Vioxx was only one, was in effect killed by the withdrawal, as the FDA began to demand much bigger pre-approval trials.

Statistics back up the argument: while the proportion of new drugs submitted that are approved has been relatively constant in recent years, the absolute numbers put forward for scrutiny are well below their peak of 15 years ago. Terry Maguire, an adviser to the UK’s medicine safety committee, argues that in spite of the “mind-boggling complexity” of the science and the fact that “data come from companies, which have vested interests”, regulation works well

Dr Nissen disagrees. He says the FDA lacks the resources to scrutinise trial results and reports of side effects in detail. Others suggest the difficulty is still greater at the EMA, which spends less time sifting through patient data, instead accepting summaries provided by the companies. He also wants to see criminal penalties for companies that fail to submit full details of studies they conduct.

Ironically, his own 2007 “meta-analysis” of Avandia, which examined different studies of the drug, was possible precisely because GSK had not only submitted its studies to the regulators but also made some of them public. That was partly the result of a deal with regulators earlier that decade when the company was fined for tardy reporting of suicidal feelings in children taking another of its drugs, the antidepressant Seroxat.

In fact, since the initial approval of Avandia, much has changed. Harder end-points have been agreed, systems to identify side effects have improved and regulators much more frequently demand – and companies implement – “post-marketing studies” to identify problems. Prof Hill says many of the necessary reforms are now in place. “If you look back to the mid-1990s, the industry was getting what it wanted and regulators were being bullied,” he adds. “Now it’s the other way round.”

He also cautions that it would be impractical to wrest control of trials from drug companies entirely: while governments, clinicians and academics could contribute more, they have neither the money nor the expertise to do as much as industry.

Yet further evolution is still thought necessary in the shifting relationship among regulators, patients, healthcare systems and drug companies. The first aspect is redoubled research to identify clearer genetic markers and other signals to understand which patients respond best to new drugs and which would suffer and should avoid them. Combined with new diagnostics, that would help to identify safer, more effectively targeted treatments.

In response, companies will have to shift further from the intensive selling of drugs to as many patients as possible, towards more “evidence-driven marketing” justified by data showing greater efficacy in smaller sub-groups of patients. The problem is that such markers are still difficult to identify and costly to implement.

Also badly needed is the creation, in combination with governments and health services, of more detailed electronic systems to supplement the information from clinical trials, which study small numbers of “ideal” patients. Monitoring risks and benefits of medicines once they are widely prescribed shows how they behave in ordinary patients, often with multiple diseases and taking a range of drugs.

“There is very substantial under-reporting of adverse drug reactions,” says John Thompson, a pharmacologist at Cardiff University. More data would help in drug development but would also impose extra requirements on regulators and doctors to restrict the use of drugs as problems emerge.

Finally, greater transparency will be needed, if only to counter suspicions of excessive industry influence. That involves removing inconsistencies in the extent and speed of information provided by companies on their trials; and circulating information as side effects are identified. The EMA board next month will consider just those sorts of proposals to explain its decision-making in more detail, as well as to declare any potential conflicts of interest among its advisers.

But the EMA’s Prof Eichler stresses that greater information will also need to be interpreted carefully by doctors, the public and politicians alike. “There is still a lot of uncertainty about the risks and benefits of drugs, which will not go away any time soon,” he says. “If people want certainty, very soon we will not have any new drugs.”

The Blogosphere Expands: “What’s Up Doc?”


As I mentioned in previous posts, with the advent of Social Media, such as blogs and Facebook etc, the messages of the internet are individually based as opposed to a singular corporate agenda. In the case of the SSRI drugs, it is clearly the individual and the consumer who are dominating the discussion (although some pharmaceutical companies have tried to get in on the action but failed miserably). Amongst the many patient advocate blogs, there are also a surprising number of blogs written by Doctors, Psychiatrists and those in the mental health field in general. One such blog that struck my eye recently is the “Family Dysfunction and Mental Health’ Blog, apparently written by (Doctor) DAVID M. ALLEN M.D.

Dr Allen writes about many issues, but in his post ‘SSRI tales‘ I have found many discrepancies throughout his opinion of SSRI drugs.

The following are some excerpts from Dr Allen’s Post that I have issue with :

SSRI Tales
In 23 years of clinical experience prescribing them since they first made the scene, I have found that the type of antidepressant medications called Selective Serotonin Inhibitors (SSRI’s) are, for the majority of patients (with some important exceptions described in the next paragraph), relatively side effect free. Especially when combined with a long acting benzodiazepine tranquilizer such as Clonazepam, they are also highly effective for many patients who have major depression, panic attacks, obsessive compulsive disorder, PTSD, or the extreme emotional hyper-reactivity characteristic of borderline personality disorder.

Just so I don’t have to keep answering the same question, YES, some people do indeed have nasty side effects from them. YES, the drugs can increase suicidal ideation for some patients under some circumstances. YES, they often wreck havoc on sexual functioning. YES, they can have nasty withdrawal symptoms if stopped cold turkey, especially Paxil. YES, they do not work for everyone. But NO, there is not a shred of clinical or experimental evidence to back up Robert Whitaker’s assertion that patients who get better with the meds in the short run are made worse by them in the long run

First of all I would like to seriously question the validity of the prescribing of SSRI drugs for any emotional, psychological stressor or behavioral problem. Do doctors ever wonder that perhaps the prescribing of drugs is not the answer for panic attacks, depression, OCD or anxiety? Do they even consider that there might be alternatives? Do they ever consider that the root causes of these ‘disorders’ are many and varied; and that surely it is preposterous to expect a chemical to be a cure all for the myriad of different reasons why people become depressed of anxious? I do realize that most western doctors are indoctrinated into believing that everything can be helped by popping a pill, but in the case of mental health which is itself totally subjective and often ambiguous, surely before medication is even considered the patients diet and general health should be taken into consideration? Also, there are the environmental factors, if someone is depressed because they hate where they live, they are trapped in their job or they have just generally have had enough of life kicking the crap out of them, how is an SSRI supposed to magically make these environmental factors disappear? They can’t of course, and they don’t…

A doctor wil usually argue this premise with something like; “the SSRI’s help to get the patient on their feet, to bring them clarity so that they can cope with their predicament, deal with their issues etc etc”. And this is all very fine, and it is a good argument indeed, but in the majority of cases people are prescribed these drugs with no monitoring from their doctor and no talk-therpay offered (and if it comes, it’s months later or the person has to pay for it and the mentally ill are more than usually too poor to afford therapy).

Unfortunately the actual situation is that many people are left dangling on these drugs long term because doctors mistakenly( or conveniently) assume that the patient must be doing well because they are on the drug a long time. Do these SSRI advocating doctors ever stop to think that perhaps the patient cannot come off the drugs? And do they ever stop to think that perhaps the patient is so blitzed and numbed out of their mind that they can’t even make it down to their doctors surgery to ask to be taken off the drugs? Do doctors not realize just how completely disempowering it is for a desperate and vulnerable patient to be offered drugs for dealing with life problems, fear and disappointment. Do they not see the illogicality of this approach to emotional well being?

The issues of SSRI’s go way beyond the fact that they cause awful side effects. Whether this happens in 30% of patients, 50%, or 10% of people is not the issue for me anymore, the issue now is- why are they prescribed at all? And what is the justification of this compulsive urge to prescribe?

Personally, I think high prescribing doctors and psychiatrists use these SSRI drugs as a convenience, it means less work for them and they can fit more patients into a day; this was certainly the case for my own GP, and I figure it likely for many others too. It means the doctor doesn’t have to even deal with a patient anymore. He can just keep writing 3 month scripts, and when (or if) he does see the patient it’s such an irregular occurrence that the doctor can barely tell what the drug is causing or what the patients ‘original diagnosis’ is causing. Where does the problem begin and the SSRI effects end? Doctors certainly don’t know, but they (again conveniently) try to pin the patients increase in problems on their original condition. So if you are prescribed an SSRI for depression and you get worse, the doctor blames your depression not the SSRI, so effectively he blames you not the drugs. Or let’s say you are prescribed an SSRI for anxiety and the SSRI makes you more anxious, what does a doctor do? Well, mine upped the dose of Seroxat, which had catastrophic consequences. Of all those complicit in the grand SSRI Hoax, it is doctors (regular GP’s and MD’s) who are first in the line, choosing their targets at will and whim. What gives them this right?

Also, which has been proven- these drugs can mimic, create and propagate psychiatric illnesses and they can increase depression and anxiety. They can perpetuate and worsen the conditions they are actually prescribed for. So without at least weekly monitoring, how is a patient or indeed a doctor supposed to know what is causing what?

Quite simply, most doctors who prescribe these drugs do not know what is going on with their patient while the patient is on them, because they rarely see their patient and when they do, the doctors decision is based not on fact, insight or science, it’s based on guess work. And unfortunately, this random guess work can often cost a patient his livelihood, his relationships and sometimes his life...

The tragedy of mental illness is not the illness, the symptoms or the disorder, the real tragedy is how it is diabolically (mis) treated…

GSK : Avandia And Other Drug Catastrophes


Brilliant article from the American Chronicle documenting recent drug disasters involving GSK.

http://www.americanchronicle.com/articles/view/183283

Vaccine suspensions and drug disasters has made 2010 a annus horribilis for Glaxo Smith Kline

Christina England
September 07, 2010

GlaxoSmithKline the drug giants, have spent the last few days trying to stay off the bottom of the FTSE 100, especially after the UK’s Medicines and Healthcare Products Regulatory Agency said that it’s diabetes treatment Avandia should be pulled from sale, over concerns that it can lead to heart attacks in some patients. This came at a particularly difficult time for GlaxoSmithKline and was yet another nail in their coffin, as Pandemrix, their vaccine for the swine flu, is currently also under the magnifying glass, having been suspended by Finland, Sweden, Poland and Nepal, due to a growing number of reports of adverse reactions.

Last night the UK documentary series Panorama, revealed that despite warnings that the drug Avandia should be removed from the market, millions of prescriptions for the drug were still being written every day and doctors had been ignoring the advice given, by failing to warn patients about potential safety issues. The safety trials which had been studied by the agencies approving the drug, were shown to be substandard and it was revealed that it was GSK themselves who had carried out the safety trials showing only the ones that boosted favourable results. These revelations appeared to have caused GSK to finally hit the bottom of the FTSE with a massive thud, as shares plummeted 19.5p to 1,249p. This was despite their insistence as usual that both Avandia and Pandemrix were both safe and effective.

I am sure that even GSK would agree with me, that this has definitely been a ‘annus horribilis’

The term ‘annus horribilis’ for those of you who are not familiar, means a horrible year and was derived from the Latin phrase ‘annus mirabilis’ – year of wonders (or miracles). The saying was made popular after Queen Elizabeth II used it to describe 1992 – the year that the marriages of her two sons Charles and Andrew broke down and Windsor Castle caught fire. This year however, it is particularly apt to describe the year the drug giants Glaxo Smith Kline are having.

Last night the UK public were horrified to learn that the popular diabetes drug Avandia used to lower the blood sugar in millions of diabetes sufferers, was actually causing many of them to suffer heart attacks. Panorama’s brilliant journalist Shelly Jofre explained how GSK bends the facts, fixes data and have huge conflicts of interest.

Yesterday’s Daily Mail (who had a privileged early viewing of this excellent documentary), also described the GSK antics. In their article by Jerome Burne Secrecy of drugs watchdogs puts us all in danger Burne wrote-

“it is now clear that the drug regulator in Europe (The European Medicines Agency) which licensed Avandia for the UK ten years ago ,was worried about a heart attack risk even then. But this was never made clear to patients and the trial requested by the agency to test specifically for heart attack safety took nine years to report”

Of course these were not the only two problems that GSK have encountered this year. Not so long ago the Rotarix vaccine was suspended by the USA, Switzerland and Jordan because it was found to contain pig virus. Although cleared of causing potential harm this could now upset some Muslim activist groups as they cannot have vaccines that contain pork substances.

Fluarix was another GSK vaccine to have caused difficulties this year and was banned by Australia altogether, after the vaccine was found to be causing children to suffer vomiting, fevers and seizures. The side effects affected some children so adversely that it left one poor child in a coma, causing Australia to take the unusual step of actually banning the vaccine.

Then we come to the Cervarix vaccine, this is the HPV vaccine. I have been studying the UK reporting system for adverse reaction reports on MHRA website – April 23rd 2010 Suspected Adverse Reaction Analysis CERVARIX Human papillomavirus … These are also not looking too healthy.

Glaxo Smith Kline need to seriously clean up their act if they want the public to trust their drugs and vaccines. It was not too long ago that the truth about Seroxat/Paxil, another GSK drug with dirty secrets, emerged.

Watch this video The Evidence However, is clear,Seroxat Scandal for a full Seroxat history. The video was given to me by a very good friend and colleague Bob Fiddaman who writes the blog Seroxat Sufferers Stand up and be Counted

Is it any wonder the public are refusing vaccines and are reluctant to take medications and are turning instead to alternative health remedies?

Anyone wishing to see the podcast of the Panorama documentary also go to Seroxat Sufferers Stand up and be Counted

GSK Avandia Drama: A Matter Of Trust?


Just as I thought it would, the GSK Avandia Scandal has erupted into the mainstream with the same outrage and force as Seroxat did when panorama made their first documentary about the drug back in October 2002. That’s almost 8 years ago now. It is difficult to believe that the same thing could happen again. Surely the regulators would have learned that this particular pharmaceutical company just cannot be trusted to put anything before its profits (never mind making patient health and transparency a priority). How many events like this have to happen before governments begin to start viewing GSK’s business model as a serious threat to patients, consumers and the public? How can any product or new drug that this company submits for regulatory approval ever be trusted? Pharmaceutical drug regulation needs to be separate and it needs to be independent from pharmaceutical influence. For far too long, this cosy business relationship has been detrimental to public health. This needs to change and it needs to change NOW. Seroxat caused just as much (if not more damage) but they kept it on the market anyway. if Avandia stays on the market then quite simply we can assume that the pharmaceutical industry can get away with murder and there is nothing anyone can do about it. How many risks does a drug have to induce before it is considered to outweigh its benefits? Seroxat was driving many children, young people and indeed all ages to kill themselves, self harm and worse, yet the regulator showed its complete inability to protect the public from the devastating human carnage and suffering that this drug caused…Is that about to happen again also? .. Scary times folks… scary times…

http://www.google.com/hostednews/ap/article/ALeqM5ilSwu6oKQU66dIKyBeRTuanGa-vgD9I2LHKG0

UK regulators want Avandia diabetes pill pulled
(AP) – 17 hours ago
LONDON — GlaxoSmithKline’s controversial diabetes pill Avandia should be pulled from the U.K. market because of concerns that the drug can increase the risk of heart attacks, British drug regulators said Monday.
The Medicines and Healthcare products Regulatory Agency (MHRA) said an independent panel of experts had advised it that the risks of Avandia outweigh its benefits, and that the drug should no longer be sold in Britain. The body said it had sent a letter to doctors in July advising them to consider alternative treatments.
The British Medical Journal also called for the immediate withdrawal of the drug, saying it should never have been licensed in the first place.
Avandia was approved by the European Medicines Agency in 2000 to help lower blood sugar levels in patients with type 2 diabetes. The drug is currently under review in Europe and the U.S., and European regulators are scheduled to meet Wednesday to decide Avandia’s future.
GSK maintained that its extensive research involving over 50,000 patients has showed that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes drugs.
“We continue to believe that Avandia is safe and effective when it is prescribed appropriately,” the London-based company said in a statement.
But the British Medical Journal was critical of both GSK’s research methods and the European approval process, outlining what were described as multiple problems associated with Avandia’s safety in a report published Monday.
In the U.S., the Food and Drug Administration has placed Avandia under scrutiny since 2007, when a study suggested that patients taking the drug were 43 percent more likely to experience heart attack than those taking other diabetes drugs or no diabetes medication.
Copyright © 2010 The Associated Press. All rights reserved.

The Avandia Scandal : The Plot Thickens…


I have just done some reading on the Avandia Scandal which is just about to explode in the mainstream news. There are many aspects of this Avandia story that echo those of Seroxat. Avandia is still being prescribed in the UK despite being recommended for withdrawal two months ago, BBC Panorama has found.

GSK have released a statement similar to the one they released when the dangers of Seroxat were exposed by the BBC investigative team a few years ago.When Seroxat was first exposed by panorama there was also a call by politicians, GP’s, psychiatrists and coroners for it to be withdrawn

GSK … The Un-Constant Gardener..

See the GSK Avandia-Panaorma statement here : http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=27254

GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, ‘A risk worth taking?’ which is scheduled to be aired this evening.

We are concerned that the BBC Panorama programme could alarm patients and their families about the use of Avandia (rosiglitazone) for the treatment of type 2 diabetes. This is a chronic and serious disease that if left untreated can result in serious health problems.

Patients concerned by the programme should seek advice from their doctor and not stop their medication.

The company has not seen the programme but denies any suggestions that it has put patients at risk. We consider patient safety a priority.

Avandia is currently under review by the European (EMA) and US (FDA) medicines regulatory authorities and GSK acknowledges the significant efforts these independent bodies have made to apply scientific rigour to understanding the benefit-risk profile of Avandia.

We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. No other diabetes medicine introduced in the last 10 years has such an extensive safety database. The results from this research programme have been given to regulatory authorities worldwide.

Our view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.

Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines. We continue to believe that Avandia is safe and effective when it is prescribed appropriately.

The company understands that the BBC Panorama programme will feature an audio recording of a meeting between GSK medical and clinical experts and Dr Steve Nissen. This meeting, which was hosted by Dr Nissen, took place on 10th May 2007. Four GSK scientists met with Dr Nissen to discuss the scientific data on Avandia.

The audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded. Selected extracts from this audio recording have already been provided by Dr Nissen to The New York Times newspaper.

In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the “secret tape the drug company would rather you didn’t hear.”

On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording. The company today (6 September) posted the recording to its website http://www.gsk.com.

The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.

For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia.

We have diligently shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.

We remain fully committed to maintaining best practice disclosure of clinical data for all our medicines to serve the interests of patients, physicians and regulators.
GlaxoSmithKline enquiries:

GSK, Avandia and Seroxat : “It’s all just a little bit of history repeating”


Hello Readers.

I am sure some of you are as interested as I am to see the new BBC panorama documentary on GSK’s diabetes drug ‘Avandia‘, which airs this coming Monday at 8.30 on BBC 1. Panorama originally raised mainstream awareness to the hidden dangers of Seroxat and the unscrupulous dealings of GSK and the regulator back- the MHRA- in the noughties. And it seems at the beginning of a new decade Glaxosmithkline have repeated the same suspect and sinister corporate behavioral pattern with Avandia. The similarities are uncanny and they are also extremely disturbing. It seems that GSK has once again hidden negative data from the public and in the process put hundreds of thousands of lives at risk. It is seriously unbelievable how they get away with this sort of thing but I am very grateful that the BBC and Panorama are once again bringing awareness to the situation. It remains to be seen what the UK regulator (the MHRA) has to say about Avandia, but considering their inept response to people dying and being damaged from Seroxat for almost 20 years now, I wouldn’t expect much consideration (or even participation) from them in this documentary. In fact, I don’t have any faith in them whatsoever.

For more on the Avandia Scandal , check out Ed Silverman’s articles from Pharmalot :

http://www.pharmalot.com/?s=Avandia

Seroxat Secrets and Seroxat Sufferers have also written posts on the subject, check them out here:

http://seroxatsecrets.wordpress.com/2010/09/04/panorama-the-mhra-glaxosmithkline-and-avandia/

http://fiddaman.blogspot.com/2010/09/shelley-ankle-biter-jofre-is-at-them.html

GSK V’s The BBC : Panorama Exposes Avandia


News just in folks from Seroxat Sufferers. The BBC Panorama series (who also did 4 documentaries about Seroxat) have come up trumps again, this time their investigation focuses on the dodgy GSK drug Avandia. I must say Mr. Fiddaman was most certainly quick on the draw with his excellent post on this.

Check Bob’s post out here : http://fiddaman.blogspot.com/2010/09/shelley-ankle-biter-jofre-is-at-them.html

And from the BBC website : http://www.bbc.co.uk/programmes/b00tr25t

I am very impressed that Panorama and the BBC are continuing to question the dubious practices of GSK and the drugs they promotes. It seems that Avandia is becoming as much the new Seroxat Scandal as Seroxat was the new Thalidomide. Kudos and thanks also to Shelley Jofre for coming back to our screens once again to question the ethics and morality of the GSK Goliath. I recommend anyone who has been impacted by the current corrupt state of the pharmaceutical industry and ineffective regulation of drugs to watch this documentary, it will be transmitted on Monday at 8.30 and no doubt those outside of the UK will be able to access it online afterwards. Essential viewing in my opinion and I already have my VCR set to record.

The Internet … Propaganda Blasting And The Rise Of Counter Opinion


For those of you that are interested, today I want to write about the internet and how it is changing the world as we know it in more ways than anyone ever imagined. In the days before the internet age, people didn’t have as much access to information that was not prescribed by either libraries, governments, books, television, radio and newspapers. Of course there were always ways of distributing counter opinion such as through pamphlets etc but there was nothing like the universal accessibility of the Web.The majority of information was controlled, censored or prescribed, often by a an entity with an agenda or agency such as political parties in power, academic institutions, established institutions, corporate organizations etc. Those days are long gone. In the internet age, more and more people are accessing their information and entertainment straight from their PC, iPhone or laptop. Anyone with access to the Web can now have their voice heard (and also listened to too). So how does this affect industries like the pharmaceutical and ideologies like psychiatry?

I think that it has been affecting both the industry and psychiatry for quite some time now and will continue to do so. When I was prescribed Seroxat back in 1998, the internet was there but it wasn’t used as much as it is now. The new generation don’t buy newspapers and although I am in my 30’s I can’t remember the last time I bought one myself. The 21st century generation interact online through Facebook, Myspace and Youtube, they share information through email and they read almost everything they choose online. Back in 1998, there was little (if any) information about psychiatry and the pharmaceutical industry online, and if there was you had to search long and hard for it. Nowadays, blogs are getting more hits than corporate websites. Blog columnists are dominating the discourse in every topic online, from politics to psychiatry and everything else in between.

One very important aspect of all this change and social media domination is that every individual has a chance to voice their experiences and their opinion on whatever they choose to. No longer is news filtered primarily from a singular agenda through newspapers, advocacy groups or other means. This means less censorship in general and more freedom of expression on the web. It also means the focus of filtered information is less controlled and therefore counter opinion on any topic gets a chance to become just as loud as contrived propaganda. Some blogs that I know of are reaching hits in the hundreds of thousands- gained over just a couple of years, their content is showing up on the first pages of google hits for certain keywords in relation to the topics they cover and the blogging community becomes stronger by the day. The tide of change is in full swing folks, and I welcome you all aboard.

http://www.tv3.ie/shows.php?request=tonightwithvincentbrowne&tv3_preview=&video=26549