Mark Kramer - M.D cum Jazz Man

Mark Kramer - Jazz Pianist and Consultant to the Pharmaceutical Industry

It would appear that I and others have ruffled the feathers of Professor of Psychiatry, Mark Kramer over at the Boring Old Man website.

The author of Boring Old Man, Mickey Nardo, himself a retired psychiatrist, is, just like me, asking questions regarding some of GlaxoSmithKline's ghostwritten publications, namely 329 and 352, both Paxil studies.

This prompted a lot of debate in the comments section of his post entitled, "Paxil study 352 – what’s ghost-writing?"

What started off as a mild debate, sadly turned into a free-for-all finger pointing tirade that clearly misses the message of the original post.

GlaxoSmithKline's Requip and Paxil in the Dock

British pharmaceutical giant, GlaxoSmithKline, have just been ordered to pay almost €200,000 [$260,000 US] to a man who claimed that Requip [ropinirole] turned him into a sex and gambling addict.

Requip, a drug to help with Parkinson's disease, carries many side effects which can include hypersexuality and compulsive gambling, even in patients without a prior history of these behaviours [1]

Didier Jambart, writes thejournal.ie, had suffered side effects after being administered the drug Requip in 2003 for the illness, which causes tremors, slows movement and disrupts speech.

“It’s a great day,” he said. “It’s been a seven-year battle with our limited means for recognition of the fact that GSK lied to us and shattered our lives.”


In other news, a US jury has awarded $1.5 million to the family of a man who committed suicide.

Joseph Mazella, a 51 year old high school basketball coach and teacher, had been prescribed GlaxoSmithKline's antidepressant, Paxil. Strangely, Mazella was on the medication for 10 years in which time he never once saw his prescribing physician, William Beals, M.D.

On Aug. 9, 2009 Mazella and his wife contacted Beals who magically made a diagnosis over the telephone before doubling Mazella's Paxil dosage from 20mg to 40mg and also adding Zyprexa.

Story continues here

Comment

Here we have two cases which, in essence, pretty much amount to the same in as much that two people were given psychiatric drugs that made them do things that they really had no intention of doing.

I'm currently reading Joseph Glenmullen's book, "Prozac Backlash" to try and get a better understanding of the serotonin-dopamine connection.

Glenmullen writes:

"Dopamine is a close chemical partner of serotonin. A large body of research over decades has implicated dopamine, not serotonin, in these disorders, regardless of whether or not they are caused by medications or by diseases such as Parkinsons...

"As reports of these side effects occuring with the Prozac group (SSRi's) have mounted, researchers have been puzzled by the question of how drugs that boost serotonin could cause side effects usually linked to dopamine.

"Working out the full details of the serotonin-dopamine connection may take decades or more. Meanwhile, we are left with the clinical reality of these serious side effects, which in some cases are devastating. The unfortunate irony is that drugs heavily promoted as correcting unproven biochemical imbalances may, in fact, be causing imbalances and brain damage."

The promotion of SSRi's such as Paxil has seen pharmaceutical companies spend billions of dollars on promoting products that they really know nothing about. Withdrawal reactions to SSRi's and reports of suicide are downplayed by pharmaceutical spokespersons and key opinion leaders, who, ironically, are paid vast amounts of dollars by pharmaceutical companies to promote the use of SSRi's.

In the six or so years I was taking Seroxat [Paxil] I did many things that I wouldn't have done if I had not taken it. I look back now and wonder if a; Seroxat induced these thoughts and b; if my brain has been damaged by long term use of Seroxat.

Will I and the millions of others who have, at some point, taken an SSRi be more prone to develop Parkinson's or Huttingdon's disease?

Only time will tell.

That's some price to pay for taking a pill that was apparently safe and effective, huh?


[1] Bostwick JM, Hecksel KA, Stevens SR, Bower JH, Ahlskog JE (2009). "Frequency of new-onset pathologic compulsive gambling or hypersexuality after drug treatment of idiopathic Parkinson disease".  [Link]

Glaxo Shortlisted for Britain’s Most Admired Company

Definition of ADMIRATION [merriam-webster.com]

1 archaic : wonder
2 an object of esteem
3 delighted or astonished approbation

Despite Glaxo's recent plea of guilty to fraud and subsequent $3 billion fine in the US, Britain sees Glaxo as a totally different corporation.

Glaxo have been shortlisted for one of Britain's Most Admired Companies awards by Management Today, in association with the Business Standards Institution [BSI]

The awards, write Management Today, are a peer review of corporate reputation. Canvassing the opinions of 200 of the UK’s largest companies, they are the only awards of their type in the UK.

Glaxo are no strangers to receiving awards from Management Today. After being shortlisted for Britain's Most Admired Companies in the year 2000, they actually went on to win it!

Management Today claims that it aims to help managers and business leaders "succeed today, and keep succeeding tomorrow". BSI, who are also associated with the awards, claim that "for more than a century, we've been challenging mediocrity and complacency to help our clients across the world embed excellence into the way they work…so they perform better, reduce risk and achieve sustainable growth.

On hearing the news of Glaxo's nomination I wrote to the editor of the Management Today website.

Dear Sir/Madam,

GSK, Avandia and Jack the Ripper

I always love it when GSK attempt to cover themselves in garlands, particularly after being fined $3 billion for, amongst other things, marketing deathly drugs to children.

The Washington Post recently ran an article entitled, "As drug industry’s influence over research grows, so does the potential for bias." The article was heavily critical of Glaxo's bias when it came to reporting all the facts in clinical trials.

The Washington Post article centred around a 2006 report that compared three diabetes drugs, one of which was Glaxo's Avandia. The reported concluded:

"We now have clear evidence from a large international study that the initial use of [Avandia] is more effective than standard therapies" - Lawson Macartney, Senior Vice President of GlaxoSmithKline

What Macartney failed to add was the trial, according to the Washington Post,  "had been funded by GlaxoSmithKline, and each of the 11 authors had received money from the company. Four were employees and held company stock. The other seven were academic experts who had received grants or consultant fees from the firm."

The article, to date, has prompted 645 reader comments, the majority of which are highly critical of GlaxoSmithKline.

So, in a massive PR [Yawn] exercise, Glaxo have responded with the usual roll-out of  "we don't do this anymore". 

Jack the Ripper [presumed dead] was a notorious unidentified serial killer during the late 1800's. His murdering spree, which some believe to be 5 women, involved the mutilation of his victims.

Can you imagine if, during the late 1800's, Jack admitted these killings and issued a press release stating that he was a good man now and didn't kill any more? Furthermore, can you imagine if Jack had been caught by the investigative police force at the time and fined rather than imprisoned for his crimes?

Jack the Ripper was a deplorable man [could have been a woman, although I doubt it] who carried out heinous acts against vulnerable women. Could we, as a nation of sane mind been forgiving if Jack had publicly announced that he had turned over a new leaf?

There are many critics of GlaxoSmithKline, I remember one blogger many years ago using the abbreviation GSK to form Global Serial Killers - He [could have been a she, although I doubt it] was pretty much on the money.

Let's take a look at Glaxo's response to the Washington Post article.

Let's also take a look at how Jack would have made a similar statement.

GlaxoSmithKline - You're An Embarrassment

In the words of Suggs, lead vocalist with Brit Ska/Pop band, Madness, "You're An Embarrassment."

Our uncle he don't wanna know he says

"We are a disgrace to the human race", he says

"How can you show your face

When you're a disgrace to the human race?"

No commitment, you're an embarrassment

Yes, an embarrassment, a living endorsement

The intention that you have booked

Was an intention that was overlooked

Now watch the video.

Glaxo's Paxil 352 Bipolar Trial - Ghostwritten

Who you gonna jail?

Anyone familiar with GlaxoSmithKline and Paxil will know all about the Paxil 329 study that  they [Glaxo] hired a PR firm to draft and, later, persuaded key thought leaders, mainly child psychiatrists to endorse and promote at any given opportunity. The 329 study has been dissected by many who are in agreement that it's a piece of fraud. Read more about the Paxil 329 study here and here.

Not content with one study doing the rounds in various journals and pediatric clinics Glaxo, in their infinite wisdom, hired the services, once again, of a ghostwriting team to pimp out the paroxetine 352 bipolar trial.

Rxisky Business - The Importance of Being Earnest

I've always wanted to use film titles as a title for a post, the above, Rxisky Business - The Importance of Being Earnest, kills two birds with one stone and, if I say so myself, is pleasing on the eye.

So, what am I trying to say here and why have I misspelled the word 'Risky'?

Well, this post is about the importance of filing adverse reactions to prescription drugs on RXISK.ORG, a reporting system with a difference in as much that they actually follow through the reports you send to them.

So, why report to RXISK opposed to the FDA, MHRA, TGA or Medsafe?

GSK Off-Label Promotion Continues

The GlaxoSmithKline Definition of 'Era'

Definition of Era:

A period of time characterized by particular circumstances, events, or personages - The Free Dictionary

A period of time that includes the present - GlaxoSmithKline

When GSK's CEO, Andrew Witty, claimed a few months ago that his company had turned the corner and were now operating by playing by the rules and regulations there were many that were convinced - there were many who gave Witty the benefit of the doubt.

There were many that turned a blind eye to Witty's involvement during the 'era' that he blamed on GSK's plea of guilty and subsequent $3 billion fine.

To be honest, I don't trust Andrew Witty, I don't trust any executive that works, or has worked for GlaxoSmithKline. Here we have a company who think nothing of giving drugs to children when they know that the drug could possibly kill those children. How could anyone trust a company who does that? How could anyone trust a company's CEO when he tells them it does not go on anymore and it was all part of an 'era' at GSK?

Well, the proof, as they say, is in the pudding.

GSK: "...accept that we operate differently today"

GSK's Deirdre Connolly

Deirdre Connolly, President - North America Pharmaceuticals, GlaxoSmithKline, delivered a speech to the Pharmaceutical Regulatory and Compliance Congress on November 5, the crux of which was a plea for people to start trusting GlaxoSmithKline again.

Again?

Connolly, speaking at the 13th annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, opened the gates to criticism when she told the audience, “We need those we serve, and those who make sure we conduct our business appropriately, to accept that we've changed … Continue to hold us accountable, but accept that we operate differently today.” 

Continue to hold us accountable?

Okay. Thanks for that D. I, for one, shall try my hardest.

Once again, and just like Glaxo CEO, we see the blaming of an era at GSK, implying that the current compliance protocol is robust and that they, GSK, are transparent. To be transparent one would have to give reasons why - Glaxo, on two occasions now, have covered themselves in garlands for opening their doors to show how transparent they are. What they don't tell us is that they were more than likely forced to open their doors as part of agreements and settlements with DA's and Department of Justice.

If, as Connolly suggests, “Trust is a two-way street,” then maybe she could start by retracting the study at the centre of many cases against her company.