If you don’t want to believe me…

I think we all know the internet is overflowing with all kinds of dubious sources of ‘information’ sources.

I’m a patient who suffered greatly at the hands of GlaxoSmithkline and decided to tell my story by creating this blog. As such I freely admit that I am not, by any stretch of the imagination, unbiased.

I see what I do as trying to counter (in some small way) the spin and lies that Glaxo routinely produces every week of the year.

I also hope I may be able to help some people understand what’s happening to them if they are suffering from Seroxat addiction and are trying to withdraw from the drug.

But if you don’t want to believe me, then can I suggest you look at the new blog written by Dr David Healy – Dr Healy being the internationally respected psychiatrist, pyschopharmacologist, scientist and author. I can’t recommend this blog enough. Go there now!

And for the record:

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden clinical trial data that shows exactly how dangerous a drug it is.

I believe that something must be done to help people who suffer terrible problems with withdrawal, as they desperately try to stop taking Seroxat.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of Seroxat.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Maybe you should believe me – I do know what I’m talking about.

Yet more on Ian Hudson and the MHRA

Another old post here about Ian Hudson playing fast and loose with important public health matters – how that man is still in his job in 2012 is beyond me.

Interestingly, I’ve just found this old article from the BMJ, 29 January 2005

Select committee angry over absence of drug regulator from session

London – by Lynn Eaton

Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry.

Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.

MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.

Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.

“It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible [for drug safety],” said Mr John Austin (Labour MP for Erith and Thamesmead).

The agency’s chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.

The agency’s chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. “However, because of his role in the company [SmithKline Beecham] he doesn’t get involved [in discussions on Seroxat],” said Professor Woods.

Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.

However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.

Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.

Professor Breckenridge admitted that the agency had “suffered from not being professional enough” in its communications. “We are determined to change that,” he said, explaining that the agency has just appointed a communications director.
I hope you noticed the paragraph in bold – “Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend”.

But what I find strange is that if you want to download this PDF - Witnesses for Thursday.pdf – you’ll see that it appears that Lord Warner (then Health Minister) and David Hincliffe had a phone conversation on the Monday morning before the hearing and agreed exactly who was going to attend from the MHRA… and you will see that Ian Hudson is not mentioned as a witness.

I’m confused – who’s lying then – Lord Warner or David Hinchliffe? and why?

I have emailed my concerns to members of the Committee who were there, asking questions that day, but so far I have been ignored – more than once…


The MHRA, Ian Hudson and the House of Commons

Just to follow on from yesterday’s post about the MHRA and its links to Big Pharma, I thought this might be of interest.

Below is an old post I wrote, specifically about Ian Hudson and the way he avoided giving evidence to the House of Commons select committee – he just didn’t bother to turn up – he said he had a ‘prior engagement’.

How very convenient.

A short while ago, I wrote a post about Dr Ian Hudson. Hudson is currently the MHRA’s Director of Licensing – but the job he had before he joined the agency was at GlaxoSmithKline – he was their Worldwide Director of Safety and we know from his CV that one of the drugs he had “significant involvement with” was, in fact, Seroxat…

In my previous post I bemoaned the fact that Hudson had decided to go elsewhere on the day he was expected to be questioned by the House of Commons Health Select Committee about Seroxat safety and trial data.

The MHRA has been questioned about the secret data that Glaxo kept hidden for more than a decade.

The MHRA replied that they were “confident that neither Professor Breckenridge nor Dr Hudson had prior knowledge of the data discussed in Dr Breggin’s report.”

Does the MHRA really expect us to believe that Glaxo’s Worldwide Director of Safety, who had a “significant involvement in Paroxetine” (Seroxat), did not have full knowledge of ALL the trials and data that appertained to this particular drug?

Does Ian Hudson expect us to believe this?

He was their Worldwide Director of Safety and Seroxat is one of GSK’s biggest ever blockbuster drugs… hmmmm?

This stinks.

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.

 

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