Kerry Katona: ‘I’m taking drugs for bipolar disorder’

One for my UK readers, from the Daily Mail.

Troubled star Kerry Katona has revealed she takes anti-depressants in an effort to control her bipolar disorder.

The pregnant star revealed she takes Effexor every night to control the psychiatric condition, and put her bizarre appearance on GMTV down to the effects of the drug.

Now, I’m no Doctor, but I can’t help wondering who has prescribed Effexor (an SSNRI) for bipolar disorder… not really a good idea at all.

Perhaps Kerry might like to read (and sign) the Effexor petition:

“We the individuals listed below have electronically signed this petition for the purpose of making it known that consumers treated with the SSNRI antidepressant Effexor have or are experiencing “often ignored” serious side effects of this medication. And that thousands of patients in the US and worldwide are unable to discontinue Effexor or even reduce dosage due to the rapid onset of severe withdrawal-like symptoms which often initiates before a patient begins dose reduction due to the short half-life of Effexor. Documentation of which the manufacturer, Wyeth-Ayerst has gradually disclosed now some 8 years after this drug was first licensed, being aware of these problems all along but failing to communicate this knowledge to the public and the medical community.

Wyeth-Ayerst misleadingly advertises through its Effexor labeling that only drug abusers are at risk of physical and psychological dependence, and withdrawal problems when tapering back or abruptly discontinuing Effexor usage. Wyeth-Ayerst knows such representations are false, and that all patients, including patients not having a history of drug abuse, are susceptible to withdrawal problems after tapering back or abruptly discontinuing Effexor.”

Good luck Kerry, but maybe I might suggest going to see another Doctor?

Reported deaths up 155% in the last decade… from prescription drugs

Each year, Britons are dying in their thousands because of the side effects of prescription and over-the-counter medicines. Reported deaths are up 155 per cent in a decade – and experts are seeking new safeguards, writes Nina Lakhani in today’s Independent on Sunday.

Thousands of patients are dying each year as a result of side effects from pills prescribed by GPs and hospital doctors.

And while the number of deaths from suspected adverse reactions to prescription drugs has more than doubled in the past 10 years to 973 last year, medical experts warn that as few as one in 10 deaths and other serious complications are being reported.

Doctors’ poor prescribing skills and repeated failures to recognise accurately adverse drug reactions in patients have seen deaths multiply by about two and half times since 1996.

Experts are calling for a revamp of the current warning systems designed to alert doctors to potentially lethal prescription drug treatments.

They believe tens of thousands of patients suffer life-threatening, disabling or other serious reactions that need hospital treatment because of a failure to spot and report many dangerous side effects and drug interactions quickly enough.

One study estimated that the equivalent of all the beds from seven general hospitals – 5,600 places – are occupied with patients suffering from drug reactions at any one time, costing the NHS more than £450m each year. Researchers believe around 70 per cent of adverse reactions could be avoided through better training, computerised prescribing systems and staff spending more time talking and listening to patients.

The latest revelations follow The Independent on Sunday’s exclusive report two months ago highlighting the dramatic rise in the number of drugs that doctors are now prescribing.

The drugs most often reported to have produced fatal reactions in patients (1996-2006)

Clozapine: an anti-psychotic

Infliximab: an anti-inflammatory

Diclofenac: an anti-inflammatory

Warfarin: prevents blood clots

Olanzapine: an anti-psychotic

Venlafaxine: an anti-depressant

Aspirin: prevents blood clots

Methotrexate: treats cancer and rheumatoid arthritis

Paroxetine: an anti-depressant

Rofecoxib (Vioxx): an anti-inflammatory

Source: MHRA

Please read the entire article over at the Independent on Sunday

And why are these drugs so potentially dangerous to so many people? The simple answer is that drug companies are rushing sub-standard drugs to market, ignoring or rewriting research studies that do not give them the answers they want.

Profits before patients.

Andrew Witty – patients before profits?

JP Garnier’s seat isn’t cold yet and Andrew Witty won’t officially take over GSK until May 2008 – but already questions are being asked of the new man in a new blog andrewwitty.wordpress.com

The purpose of this blog is a call of conscience and compassion to Andrew Witty, the next CEO of GSK.

We all recognise the need for pharmaceutical drugs, and some can be life savers, but surely when a pharmaceutical company appears to harm more patients than it claims to help, then something must be done to rectify and address this? We also recognise the place of the pharmaceutical industry too, but has it become a greed fueled machine run amok with no regard for the efficacy or safety of new drugs? Is the safety and effectiveness of a medication paramount? Or does a loyalty to insatiable profits affect this?
Who is willing to tackle these issues? Where does the buck stop?

And where do honesty, transparency and good ethics begin?

Many hundreds of thousands of people have been adversely affected by GSK drugs, such as Avandia and Seroxat. GSK have had thousands of lawsuits over the years regarding these particular drugs and others in the past , drugs such as Selacryn, Lotronex and Myodil. Will the new GSK CEO address the issue of Seroxat (Paxil) Birth Defects, Suicide, Aggression, Addiction and Withdrawal? Or Avandia Causing Heart Attacks? Maybe Andrew Witty will be a different CEO than his predecessor?
Maybe he will put patients before profit?

One thing is for sure, GlaxoSmithKline definitely needs a radical change of its ethical policies.

A “sanctuary from the influence” of drug companies… but not for long

Pfizer Signs Deal With Physician Social Networking Site Sermo

Pfizer on Monday announced an agreement under which physicians employed by the drug maker will be able to communicate with the 31,000 doctors that use Sermo, a medical social networking site. Sermo, founded in September 2006, provides a forum for licensed physicians to anonymously discuss diagnostic and treatment techniques, and it allows users to rank postings based on credibility. According to Sermo, membership increases by about 1,000 to 2,000 per week.

The site originally was designed to be a “sanctuary from the influence” of drug companies, the AP/Atlanta Journal-Constitution reports. However, recent polls and focus groups involving its members show a desire for industry participation, Sermo officials say. CEO Daniel Palestrant said, “Doctors in our focus groups would say, ‘In many cases, the most timely and interesting information on drugs comes from the industry. But I want that information on my terms'”.

Pfizer doctors, whose affiliation will be clearly labeled, will be able to ask questions and respond to posts on the Web site, and users will be able to identify biased statements and offer rebuttals. The access will provide the drug maker with “insights into prescribing patterns and a way to show doctors data on its drugs,” according to the Wall Street Journal. Financial terms of the agreement have not been disclosed. Rules about interactions on the site will be discussed in online “town hall” meetings involving Pfizer and physician members of Sermo. Palestrant said Sermo is considering similar deals with other drug makers.

According to Michael Berelowitz, a senior vice president of Pfizer who oversees physicians, the arrangement “creates a social discourse around the results, which is very different than a rather cold transmission through other media, where you don’t have that two-way communication.” He added, “There will be great care taken to ensure the information we provide is transparent and clear, and done with full disclosure”.

Palestrant said, “It takes a lot of courage for Pfizer to do this, because the response isn’t going to be universally positive,” adding, “Pharma is always in crisis, always under fire for something, and there have been trust issues with physicians.” The Journal notes that the partnership could “attract fresh attention to how drug companies interact with physicians”.

Source: The Kaiser Network

The Memory Hole

In George Orwell’s novel 1984, the memory hole is a mechanism for removing embarrassing documents, previous crimes and inconvenient bungles. Old documents are revised, and the original copies are consigned to the memory hole where “not even the ash remains”. It is a mechanism for “smoothing over” the actions of leadership. It is a mechanism of censorship. It is about collective amnesia.

History helps us to understand what has happened so that we can control what happens again. Even if we cannot control it, we will know not to be surprised.

Dr Aubrey Blumsohn (Scientific Misconduct) has been working hard to gather dated records of corruption and poor leadership in science and academia in general, editorial misconduct, the forgotten lessons we should not forget, and a few things that just happen to interest him. They tell a story of meaningless attempts to define and redefine what we mean by scientific misconduct, while ignoring many actual problems and the meaning of science itself. They tell a story of cover-up, deception and the bullying of those who have raised concerns. There are stories of shoddy science, some mistakes, fraud, and a few very evil acts.

Forgetting history is why some wax lyrical about the wonders of a new clinical trials register while ignoring what has already happened. It is why we ignore the fact that we already had a clinical trials register – it was called the FDA (and the MHRA). Those charged with maintaining that previous register colluded (through legislation and practice) to help commercial companies hide inconvenient clinical trials. It is why the wrong questions are asked.

“If they can get you asking the wrong questions, they don’t have to worry about the answers.”
(Pynchon T, 1995 Gravity’s Rainbow. ISBN 140188592)

How many know that Pfizer was involved in human military research in an attempt to produce incapacitating agents that damaged humans and produced (ironically) retrograde amnesia. Does that make us think differently about their more recent actions? Should it? How many recall the radiation experiments, scientific racism, the pseudoscience of eugenics and the illegal experiments carried out on poor, African or mentally disturbed children? How will our actions of 2007 be viewed in 2037?

Visit the Memory Hole:

8 October

9 October

10 October

11 October

12 October

13 October

Garnier’s ‘legacy’…?!

The battle to replace Jean-Pierre Garnier as chief executive of GlaxoSmithKline ended today when the company announced that Andrew Witty would replace JP next May.

Mr Witty, 43 and president of Glaxo’s European pharmaceuticals business, beat off competition from Chris Viehbacher, the president of Glaxo’s US arm, and David Stout, the president of pharmaceuticals operations.

JP, formerly with SmithKline Beecham, took over as group chief executive following the merger seven years ago… at the merger the share price of GSK was £21 – today the share price is £13.17

I can’t help but think that makes JP a real failure at his job.

Maybe he thinks so too, as he has said today that his legacy will be the creation of a new corporate culture at Glaxo — one of “performance with integrity”. No mention of the abysmal business performance and pitiful share price. No mention of all the law suits. No mention of the criminal investigation in the UK.

Just “performance with integrity”.

Yes, you read it right, JP thinks he has presided over some kind of golden age at Glaxo – if it wasn’t so sad it would be so very funny.

Remember this JP? – “I’ll be a hero in three years” Jean-Pierre Garnier 5 April 2004

Yeah, right!

UK Pension Fund to lead fraud fight against Glaxo

A regional UK pension fund has been appointed to spearhead a US class-action lawsuit against GlaxoSmithKline (GSK), accusing the pharmaceutical giant of misleading the market over its controversial diabetes pill Avandia.

Avon Pension Fund, which manages about £1 billion on behalf of public sector workers, was appointed “lead plaintiff” — a US term for the institution fronting a group lawsuit on behalf of other investors — over the weekend.

Although both private and public pension funds in the UK are showing an increasing interest in US class-action lawsuits, it is rare for them to take such a prominent role.

In the GSK lawsuit — which accuses the group of “fraud” and “deceit” by withholding information about the risks of Avandia — Avon was competing with the North Yorkshire Pension Fund for the role of lead plaintiff.

A US public pension fund and a group of German investors, including a subsidiary of Barclays Bank, also applied to be lead plaintiff, according to court papers seen by Times Online.

A judge in the United States District Court for the Southern District of New York appointed Avon because it had the second-largest financial interest in the case.

The German shareholder group had the largest exposure to GSK shares but was passed over for the role of lead plaintiff because of continuing uncertainty over whether German courts can enforce a US class-action ruling.

Avon says that it lost $2.6 million (£1.3 million) after a study published in a US science journal linking Avandia to increased risks of heart attacks sent GSK shares sliding 42 per cent.

The lawsuit, filed on June 11, claims that GSK “engaged in a scheme to deceive the market and a course of conduct that artificially inflated GSK’s stock price”.

GSK denies the claims and says that it will defend itself against the lawsuit.

Coughlin Stoia Geller Rudman & Robbins, the US law firm that is representing Avon, has been appointed lead counsel in the case.

The class action is open to all GSK investors who held shares in the run-up to the May price collapse.

The lawsuit is seeking financial compensation for investors who lost money when GSK’s shares fell and also to push through corporate governance changes at the company to reduce the risk of a repeat occurence.

US law firms including Coughlin Stoia and Cohen Milstein Hausfeld & Toll regularly approach UK pension funds to join US lawsuits.

So far they have met with limited interest despite the National Association of Pension Funds, a prominent UK shareholder group, encouraging its members to consider becoming involved in US-led litigation.

Source: The Times

Latest on the MHRA’s four year ‘criminal’ investigation into GlaxoSmithKline

It has been so long now (four years) that most of us have forgotten how the MHRA’s investigation started.

Perhaps it went something like this:

Just click on the thumbnails to load a full size page. Enjoy – and remember – it’s only a little bit of fun… ?

See here for more details.

Zyprexa catch up

The Zyprexa controversy – it just won’t go away will it?

There’s lots of interesting stuff over at Clinical Psychology and Psychiatry: A Closer Look:

Zyprexa for Youth: What Marketing Plans?

The Zyprexa Whitewash

Lilly Updates Label: A Little Too Late

Happy Fourth Birthday…

… yes, you guessed it – happy birthday to the MHRA ‘criminal’ investigation into GlaxoSmithKline.

It’s four years old this week.

It was four long years ago in October 2003 that the MHRA started a criminal investigation into GlaxoSmithKline because of concerns that Britain’s biggest pharmaceutical group had withheld important data from clinical trials. This data showed that Seroxat could cause an increased risk of suicide and self-harm if prescribed to depressed teenagers.

In January 2006, the MHRA told Panorama, “that the investigation has been given substantial additional resources and remains a high priority.”

But the reality is that any prosecution of Glaxo would put the MHRA itself – and Chairman Alasdair Breckenridge in particular – too squarely in the frame. What was it he told Panorama in the second of their four splendid programmes? (11 May 2003) – “What you can say with great firmness is that these drugs do not increase the risk of suicidal thought and they do not increase the risk of suicide”. Ooops!

Anyway, birthdays provide for reflection on times past – perhaps these old posts of mine will help in that reflection:

The MHRA, criminal investigations and Glaxo

The MHRA, criminal investigations and Glaxo – 2

The MHRA, criminal investigations and Glaxo – 3

What we’re talking about is the now infamous Study 329 (see here and here for details).

The Panorama Programme, Secrets of the drug trials (watch it here) made public the secret emails that revealed how Glaxo distorted trial results of Seroxat, covering up a link with suicide in teenagers. Panorama went on to reveal how GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials and that GSK-employed ghostwriters influenced ‘independent’ academics.

Want to know more? – it’s all here – And while we’re talking about Study 329 – here are some real Seroxat Secrets

Four long years, eh – how much longer can the MHRA stall?

Every single one of those 1,460 days has simply seen you and me let down by a chronic lack of action from the body that is supposed to protect patients in the UK and regulate companies like GlaxoSmithKline.

How much longer?