The Murdochs and Glaxo – the parallels…

I’ve been following the News International story with great interest. What surprised me today is the news that people think it’s wrong that James Murdoch paid off Gordon Taylor (£700,000 according to some estimates) and  included a gagging order in the agreement to stop the truth from coming out. Of course, Murdoch did this long before the details of the case were in the public domain, so he was spending big in order to try and avoid exactly what’s happening at this very moment.

There seems to be outrgage that someone would do such a thing… well, I’ve got news for you – Glaxo has been doing for years and still does..

Here’s an old post from 2007:

Buying our silence

Buying our silence – that’s what it’s all about when Glaxo opens its cheque book to ‘settle’ litigation. It has nothing to do with putting right a wrong or making sure that patients are not harmed in the future – Glaxo is simply protecting its own interests – while never admitting it did anything wrong.

Glaxo always denies it was in the wrong. “We believe we acted appropriately,” said Glaxo spokesman Mary Ann Rhyne in one case the company settled. “We deny liability. We have taken this action to avoid protracted litigation and the costs associated with that. We haven’t admitted any liability.”

In another case, GlaxoSmithKline once again admitted no wrongdoing as part of another settlement. “We’ve agreed to this settlement to avoid the delay, expense and uncertainty of litigation,” said Mary Anne Rhyne, a company spokeswoman. However, though Glaxo doled out $65 million in this case, it refused to admit guilt. Paragraph 22 of the final Order in that case, dated April 22, 2005 states:

“Neither this Final Order and Judgment, the Settlement Agreement, nor any of its terms or the negotiations or papers related thereto shall constitute evidence or an admission by Defendant, that any acts of wrongdoing have been committed, and they shall not be deemed to create any inference that there is any liability therefore.”

The US government has hit the jackpot with Glaxo. On September 12, 2006, the Huffington Post reported that Glaxo had agreed to pay more than $3 billion to settle charges by the IRS that the company under-reported profits to avoid paying US taxes.

However, here too, in true Glaxo form, the company denied any guilt and said it only paid the $3 billion to settle the case to avoid protracted litigation. That’s $3 billion… but we never did anything wrong!

You can read more about these cases here.

Maybe you see a pattern here – HUGE payouts, but only to avoid protracted litigation.

Yeah, right.

The other common thread in Glaxo’s settlements is the gagging of individuals. The agreements people sign – under subtle but nevertheless very real duress – try to ensure silence.

Typically you will not be free to carry on making public comments about Seroxat or addiction to it. Perhaps you might be forced to take down your website or stop blogging on the subject… perhaps you will not be allowed to talk about withdrawal from the drug in public… basically you’re paid to go away and shut up.

Importantly, you’re NOT paid anything for all the suffering and harm you have experienced – you’re simply paid to go away and shut up. These agreements are all about protecting companies like Glaxo – rather than trying to help injured patients. And then to rub salt into the wound Glaxo asks the court to seal any incriminating documents – it doesn’t work every time though.

What I can’t see is why Glaxo, if they really have nothing to hide, can’t settle with people but NOT gag them – why should a payout from Glaxo be dependent upon our silence… what kind of warped quid pro quo are we talking about here.

This leaves just one question: Alastair Benbow takes money from Glaxo – why can’t he be made to shut up?!

Explaining the rise in antidepressant prescribing… or not?

Ben Goldacre pointed out this new research in the BMJExplaining the rise in antidepressant prescribing.

It seems the research shows that the rise in antidepressant prescribing is nothing to do with new prescriptions, rather it’s due to more people being on the drugs for longer “The rise in antidepressant prescribing is mainly explained by small changes in the proportion of patients receiving long term treatment.” [It should be noted that the research is 5 years out of date already as the years covered are 1993 - 2005].

Hmmmm.

If that’s the case, I wonder if any research has been done into possible harm due to long-term SSRI use – by Glaxo maybe? Or Pfizer perhaps?

I wonder if patients find, when they try to stop taking SSRIs, they can’t because they have become addicted to the drug?

From the research: “…A key question remains: if the changes in antidepressant prescribing are accounted for by changes in the proportions of those in receipt of long term prescriptions, does this represent appropriate prescribing for those with chronic and relapsing disease according to current guidance or does it arise from a failure to discontinue antidepressants in those with milder illness, or both?…”

But no mention of addiction.

A very important point to be made here is that all too often, SSRI withdrawal symptoms are wrongly diagnosed by doctors as the underlying disease returning – so they simply put the patient back onto the SSRI.

From the research again: “Antidepressant prescribing is much higher compared with 10 years ago. This increase is not because of an increase in the incidence of new cases of depression, a lower threshold for treatment, an increase in the proportion of new cases of depression for whom antidepressants are prescribed, or an increase in the duration of the prescriptions written for new cases of depression. Rather, the dramatic changes in antidepressant prescribing volumes between 1993 and 2005 seem to be largely because more patients are on long term medication and this group consumes the most drugs. In order to better understand the rise in antidepressant prescribing, research needs to focus on chronic prescribing and policy needs to focus on encouraging appropriate high quality monitoring and review of those patients who become established on long term prescriptions.”

And still no mention of addiction…

It seems to me that the researchers need to see beyond the simple pattern of prescribing and look to the real reasons behind the long term use of SSRIs.

Posted in Glaxo, SSRI. 1 Comment »

60 Minutes And GlaxoSmithKline’s Whistleblower

Yet another ‘how does Glaxo get away with it’ story….

Cheryl Eckards’ job, as manager of Glaxo’s global quality assurance, “was to inspect plants to make sure that the drugs had the right ingredients, the right potency and met government standards for purity.” In fact, she was sent in because an FDA inspection had already seen problems as this plant [Cidra] (noting that “FDA inspections of drug plants are only occasional, so it’s up to drug companies to police themselves” – which is why litigation is such a critical backup.)  But as 60 Minutes put it, Eckard “found much more than the FDA had.”  For example,

The employees were contaminating products, including the anti-bacterial ointment Bactroban, which was made in a sealed tank to prevent contamination.

“They were opening up the lid and then they were sticking their body into the tank and scraping it with like a paddle,” Eckard said.

“But this product is supposed to be free of bacteria. Why would they do that?” Pelley asked.

“It saved money,” Eckard replied.

As her team continued its evaluation of the plant, Eckard says she discovered something much worse than contamination: because of failures on various production lines, she says that powerful medications were getting mixed up.

“Are you saying that different kinds of drugs were packed into the same bottle?” Pelley asked.

“Yes. And that’s shocking,” she replied.

Cheryl warned and pleaded and warned and pleaded with her bosses to shut this plant down.

Then she was fired.

See the video here (bottom of the page)… oh, and check out the sleazy response by Ian McCubbin, senior vice president at Glaxo in London: “I don’t know Cheryl Eckard. And I don’t all the details of her accusations.”  Could it happen again?  “I absolutely hope not,” he replied.

20 Years of pharmaceutical company fraud

How much longer will big pharma be allowed to get away with it?

Something’s got to change, because along with all the settlements shown below, the pharmaceutical industry is responsible for killing thousands of patients each year.

You’ll see from the chart that the last few years have been the worst for settlements – the reason is that the pharmaceutical companies that are all too happy to create drugs (and aggressively market those drugs) in the knowledge that the drugs are unsafe – putting their wealth before patients’ health.

The age of the truly innovative blockbuster drug is over – Big Pharma knows this but continues to market sub standard products to the public. This is also the reason why we have seen marketing and advertising spend leap ahead of (by two to three times) the R&D spend at every major drug maker in the world.

Here’s a great article from ED Silverman at Pharmalot:

Once upon a time, defense contractors were considered the biggest hucksters. You know, the US Defense Department would pay $10 for a pencil. Now, though, drugmakers have surpassed every other industry when it comes to defrauding the US government, according to a new analysis by Public Citizen, which calls for stiffer penalies and increased criminal prosecution of pharma execs.

The findings: Of 165 settlements comprising $19.8 billion in penalties during the past 20 years, 73 percent of the settlements and 75 percent of the penalties – representing $14.8 billion – have occurred in just the past five years. And four drugmakers – GlaxoSmithKline, Pfizer, Eli Lilly, and Merck’s Schering-Plough -accounted for 53 percent, or $10.5 billion, of all financial penalties. The chart below shows there were 10 deals in 2006, 27 in 2008, and 38 last year. Through Nov. 1, 32 settlements have been reached this year, but there have been more recent deals (see here and here).

Off-label marketing was responsible for the largest amount of financial penalties, although Glaxo recently agreed to pay $750 million fine to settle charges over numerous production problems at a former facility in Puerto Rico, signaling the feds are now eyeing manufacturing fraud as another avenue of pursuit (back story).

qui-tam-pharma-settlements-chart

The most common violation against state governments was deliberately overcharging state health programs, primarily Medicaid, and this was responsible for the largest amount of financial penalties levied by the states. And former pharma employees and other whistleblowers initiated the largest number of federal settlements over the past 10 years. From 1991 through 2000, such cases comprised 9 percent of payouts to the government, but from 2001 through 2010, they accounted for 67 percent.

The report goes on to list all violations that led to settlements: overcharging government health programs; illegal promotion; anti-trust violations; kickbacks; concealing clinical trial findings; poor manufacturing practices; environmental violations; financial violations and illegal distribution.

 

Chuck Nemeroff – really, really pissed off… but still really, really rich!

Did I mention the textbook that Chuck Nemeroff wrote, oops – or rather he didn’t, but he might have done, or at least he might have seen some drafts and approved them… who knows?

Probably not Chuck  because his memory is so bad – maybe that’s why he forgot to disclose all that cash he got from drug companies (wasn’t it about $1.5 million?).

That’s one poor memory!

Anyway, now he’s really pissed off and wants to sue POGO because they ran a story about the ghostwritten Nemeroff textbook – and so did the the New York Times in their story: Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say

Here are some downloads for you while away the long winter hours with – thanks to 1 Boring Old Man

POGO Letter to NIH on Ghostwriting Academics
November 29, 2010 – Revised December 9, 2010
Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say
November 29, 2010
APA Statement: Psychiatric Book Not Ghostwritten
November 30, 2010
Ghostbusters at POGO
December 1, 2010
Letters from Drs. Nemeroff’s and Schatzberg’s Lawyers to POGO
December 2, 2010
NYT Corrections
December 8, 2010
POGO’s first reply to letters from Dr. Schatzberg and Dr. Nemeroff
December 8, 2010
Nature Editorial
December 8/9, 2010
Letters from Drs. Nemeroff’s and Schatzberg’s Lawyer to POGO
December 9, 2010
POGO’s second reply to letters from Dr. Schatzberg and Dr. Nemeroff
December 9, 2010

Interesting that Nemeroff thinks his reputation has been damaged by these revalations, rather than by what he has actually done in his long and chequered career.

Read more about Professor Charles Nemeroff and his links with big pharma – if the price is right he’s your man.

The book that Chuck Nemeroff did NOT write…

I think we all know about Professor Chuck Nemeroff and his links with big pharma – if the price is right he’ll sell anything for you. We know he’s put his name to ‘research’ papers that have been written by medical PR firms (ghostwriting).

But an entire book….??!!

Thanks to Dr Ben Goldacre for this.

From the New York Times: Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say
Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company – Glaxo.

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”
The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.

“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

Words fail me when it comes to Nemeroff

Visit these sites for all your Seroxat/Paxil information

A quick and unashamed plug for a couple of blogs that I hope you are all regular readers of…

Seroxat Sufferers and GSK: Licence to (K)ill

I am always amazed by the sheer amount of work that Bob Fiddaman at Seroxat Sufferers puts in and if you check out GSK: Licence to (K)ill you will find one of the best set of links in the business in the Blogroll that the Truthman has put together.

I thank you.

FDA Avandia panel member failed to disclose he was on Glaxo’s payroll…

… and guess which way he voted??

In fact the panel member in question, David Capuzzi, was one of only three experts who voted for Avandia to stay on the market with no additional warnings.

Not a conflict of interests, oh no, of course not!!??

This from Jim Edwards at BNET UK:

The news that one of the doctors on an FDA panel assessing whether GlaxoSmithKline (GSK)’s diabetes drug Avandia causes too many heart attacks failed to disclose he was a paid speaker for the company points out a giant hole in the FDA’s regulations: The disclosure form that outside experts who advise the FDA on risky drugs are required to sign only requires experts to list fees from speaking or writing  for a drug company for the “Last 12 months or under negotiation.” That’s too short a time period to catch most conflicts in the drug business.

The Wall Street Journal reported that endocrinologist David Capuzzi — one of only three experts who voted for Avandia to stay on the market with no additional warnings — received $14,750 in total from GSK over the last couple of years. (His lecture topic was Lovaza, a heart drug, not Avandia.)

But if you check GSK’s payment disclosure forms back through Q2 2009 (and GSK’s admission that it paid Capuzzi $3,000 in Q2 2010 and another $8,000 before it started disclosing the payments publicly) it turns out that even if Capuzzi had filled in the FDA form correctly he only would have had to report $6,750 of his GSK income — less than half his actual financial conflict with the company.

  • UPDATE: The same thing applies to Dr. Abraham Thomas, who voted to remove Avandia. He was a speaker between September 2007 and September 2008 for Takeda. If he had filled in the form correctly his conflict would not be noted because it occurred more than 12 months ago.

Clearly, 12 months is too short a timeframe to accurately judge whether someone is conflicted or not. Research work sometimes takes years to complete, and publishing studies afterwards can add even more years to the process. BNET readers discovered how a too-short timeframe can cover up potential conflicts when I noted that Washington University School of Medicine’s Dr. Joan Luby, who authored a paper recommending that 3-year-olds be given antipsychotics, had failed to disclose in 2009 that she received payments from Janssen (the unit of Johnson & Johnson that markets Risperdal), or that she has given talks sponsored by AstraZeneca (maker of Seroquel), and has been a consultant for Shire (maker of Adderall XR and Vyvanse).

Some medical journals require conflict disclosures going back as far as five years. The FDA should do the same.

Related:

Sara Carlin – death by Paxil

I came across the above named video, ‘Sara Carlin – death by Paxil’, on Bob Fiddaman’s website Seroxat Sufferers.

Bob has been following the inquest into the death of Sara Carlin. Yesterday the jury returned its findings.

In a  phone conversation between Neil Carlin (Sara’s father) and Bob, Neil explained that both he and his wife “…are extremely pleased with the outcome of the inquest into our beloved Sara’s Paxil related suicide with the recommendations that the jury have given in their verdict.” He added, “The jury were under very strict restraints in their ability to name or blame any party in this inquest, including the three doctors from Oakville Ontario Canada – and the drug company GlaxoSmithKline – maker of the SSRI antidepressant Paxil.”

Neil went on, “We feel that through the breadth & depth of their 16 recommendations, the jury has carefully listened to the evidence they have heard over these past several weeks & through the quality of those recommendations have identified the root cause of Sara’s death. It is our belief if these recommendations are implemented & followed in the future, that they will surely avoid the tragic waste of young life as occurred in our Sara’s case.”

I suggest you read the rest of the post here.

And here are links to more detail on the story:

Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

SARA CARLIN Ontario, Canada

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN PAXIL INQUEST VIDEO FOOTAGE

SARA CARLIN PAXIL INQUEST GLOBAL TV NEWS

SARA CARLIN INQUEST – What The Jury Should Know

Sara Carlin Inquest – “Paxil likely played important role in teen’s suicide”

Sara Carlin Inquest – The Eli Lilly ‘Links’ & Today’s Recommendations.

**Exclusive – Sara Carlin Inquest: The Bias Of Coroner’s Counsel, Michael Blain & Coroner, Bert Lauwers?

Sara Carlin Inquest – We Know How, Now Tell us Why!

The MHRA and Glaxo’s solicitiors – just how close are they?

There’s some very interesting news at Seroxat Sufferers. Bob Fiddaman has been writing a series of posts about the identities of the expert witnesses that Glaxo are using to defend themselves against the High Court action.

It’s all a bit too cosy and I defy anyone to describe Glaxo’s experts as independent (which they should be under English law).

Anyway, last Friday afternoon Bob noticed some visits to his blog – at 16.37hrs the MHRA looked in and started read the posts about Glaxo’s ‘independent’ witnesses – then 41 seconds later, in what could only be a coincidence of the most massive proportions, you can see Glaxo’s solicitors Addleshaw Goddard, reading the exact same post.

I wonder what the chances are of that happening?

Millions to one, I’d imagine. Or maybe even billions to one….

Unless, of course, there is a connection between the two organisations and they share common interests.

I’d like Addleshaw Goddard to explain this one to me.

The posts are here, here, here and here.

Enjoy.

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