Charities and their good works – continued

Well then – it seems that Bob Fiddaman over at Seroxat Sufferers has been in contact with some of the ‘movers and shakers’ behind the healthcare charities and grassroots patient groups that I find it so difficult to believe in – see my posts here, here, here and here.

There are two posts at Seroxat Sufferers detailing correspondence with Amelia Mustapha (ex Depression Alliance/Centre for Mental Health) and with Dr Chris Manning (Primhe).

I’ll leave you to read the posts and make up your own mind about what’s been said – but what I find strange is that ‘patient advocates’ can be so dismissive of campaigners like Bob Fiddaman and myself, while at the same rubbishing experts such as Professor David Healy, Richard Brook, Charles Medawar, Dr Peter Breggin, Dr Andrew Herxheimer, Paul Flynn MP and organisations such as MIND and Panorama.

Amelia, Jim and Chris seem unconcerned at the way drug companies operate – the way they bury data from clinical trials that are negative and twist words and statistics to wriggle out of any liability. Not one of the three of them seems to be interested in even considering the overall efficacy and safety profile of modern antidepressants.

They are keen however, to question the motives of anyone who takes a view that is not on-message with their own view. On this blog Jim has questioned my motives for writing. Well the answer is – I’ve taken Seroxat and I suffered greatly because of it, as did my family. I’m not going to let the drug companies get away with it if I can help it. Patients must be able to make informed consent about treatment and at the moment the MHRA and drug companies simply do not allow this.

I do not earn any money from this blog – this is not how I make my living. Amelia, Jim and Chris, on the other hand, are ‘professionals’ – who see no possible conflict of interest in taking funding from, and working with, the drug companies.

See this post here and this one here to learn about ‘astroturfing’.

Convenient honesty and Zoloft

I’ve taken this post from CL Psych – I haven’t re-written it in any way as the job has already been done and he’s done it so well.

I must say I’m amazed that drug companies such as Pfizer think they can get away with tactics like this.

Read on:

Recently, a study was published which cast doubt on the efficacy of sertraline (Zoloft) for PTSD, finding that the drug was no better than a placebo.

The kicker is that the patent has expired for Zoloft, which is why the data are now flowing more freely. I’ll make the case here that data were buried until they would no longer hurt sales to any meaningful extent, at which point data were published, at least partially as a public relations move to show just how “honest” the companies are with sharing both positive and negative results with the psychiatric community.

The Research: The latest study, which appears in the May 2007 Journal of Clinical Psychiatry, showed no benefit for drug over a 12-week period. Placebo tended to outperform Zoloft on the majority of outcome measures, though the differences were of a small and statistically insignificant degree. Patients were significantly more likely to drop out of treatment on Zoloft. It was unclear if there were any serious adverse events (e.g., suicide attempts, notable aggression, etc.) because the article did not mention them at all. Patients started this study between May 1994 and September 1996. The original draft of the study was received by the journal in March 2006. Nearly 10 years passed between study completion and writing up the data for publication.

Two prior studies found positive results found positive results for Zoloft and were published quickly, while these negative results languished until the Zoloft patent had expired. One earlier positive study did not list the dates during which the study occurred, but it seems clear that it was rushed to publication much quicker than the negative study. Another positive study was conducted between May 1996 and June 1997 and was published in 2000. It’s quite obvious why the positive studies were rushed to press and the negative study languished, is it not?

Do keep in mind that the magnitude of positive effect for Zoloft over placebo, even in the positive studies, was small to moderate. When even the positive news for antidepressants in treating PTSD show only modest improvement relative to placebo, one should tread cautiously.

Change of Heart: Drug companies have been criticized widely for failing to disclose clinical trial data (1, 2). In an effort to shore up the support of the medical community and the public at large, what could possibly make more sense than publishing negative trial results? Gee, look at how honest we are – we share the good news and the bad news! Of course, when the positive results are published as quickly as possible and the negative results are published after a 10 year delay, well after the negative results can pose any threat to corporate profits, I’m not impressed by their newfound dedication to transparency.

Note: If you are a journalist, this is the kind of story that would merit a broad audience. The plot is pretty simple to follow and it reeks of corporate malfeasance, a subject that is not new to Pfizer and its former cash cow antidepressant.

There was a comment on CL Psych’s blog about this post noting that “It’s also possible that “dissing” the old one [Zoloft] helps the sales of a newer (patented and therefore more profitable) alternative.”

So much for Pfizer and transparency.

What price honesty?

More on Glaxo and Avandia

This editorial from the New York Times:

Ignoring the Warnings, Again?
The latest findings on Avandia, a top-selling diabetes drug, raise concerns both about its safety and about the way the manufacturer and the Food and Drug Administration have responded to signs of danger. It would be rash to make definitive judgments until the F.D.A. completes a detailed analysis. But the handling of this case bears disturbing resemblances to the Vioxx debacle, in which early warning signs were ignored by its manufacturer until the evidence of serious harm became inescapable and the drug was pulled from the market.

Avandia was approved for sale in 1999 based on studies showing that it could lower blood glucose levels in patients suffering from Type 2 diabetes, also known as adult-onset diabetes. The assumption was that the drug could alleviate some of the most damaging effects of the disease, such as heart attacks and other cardiovascular ailments. But a paper just published in The New England Journal of Medicine suggests that Avandia may instead increase the risk of a heart attack by 43 percent and perhaps the risk of cardiovascular deaths as well.

The study — an analysis of the combined results of 42 previous studies that compared people who took the drug with people who did not — is not definitive, and the absolute risk to any given patient is small. But the study points to a risk that could potentially harm thousands of patients a year. Its lead author was Steven Nissen, a cardiologist at the Cleveland Clinic, who blew the whistle on the cardiovascular risks of Vioxx, which adds to the sense of déjà vu.

What’s most troubling is the possibility that early warning signs were not adequately heeded.

Seven years ago a leading diabetes doctor warned the F.D.A. of “a worrisome trend in cardiovascular deaths,” two years later a safety monitoring group within the agency expressed concern over cases of heart failure in patients taking the drug. In late 2005 and again in August 2006 the drug’s manufacturer — GlaxoSmithKline — informed the F.D.A. that its own combined analysis of various studies showed a 31 percent increase in adverse cardiovascular events. But the company also cited studies that it said showed no evidence of harm, and the F.D.A. concluded the findings were too mixed to take immediate regulatory action.

Now, prodded by Dr. Nissen’s article, the agency has issued a safety alert, is completing its own safety analysis and will convene a panel of experts to review the data. The best hope for a definitive answer may lie in a clinical trial that won’t finish monitoring all enrolled patients until late next year.

If the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot to explain. Congress will need to probe hard to determine what risks the agency and the manufacturer were aware of and what they did — or didn’t do — to mitigate them.

Catch up on Glaxo and Avandia here and here.

“…let’s get Paxil out of mouths and into the garbage, that’s where it belongs…”

That quote is from Cindy, who is the Aunt of a young boy called Manie.

Yep – you guessed it, Manie’s mother, Julie took Seroxat (Paxil) when she was pregnant with Manie. If Glaxo had been quicker to properly warn pregnant women about the risks this might not have happened.

Julie’s new blog is here – big pharma victim – need I say any more?

“I had a normal pregnancy with Manie. I even had a couple of ultrasounds done while I was pregnant with Manie. There were no clues that Manie had a rare heart defect. I had already 3 perfectly healthy kids and did not expect for Manie to be any different.

As soon as Manie was born he began to turn blue. The more he cried the more he turned blue. Our doctor did not know what was wrong with Manie. The doctor thought that it might be his heart or his lungs.

Manie was flown to a hospital an hour and a half away from where we live. I had to stay at the hospital where I had Manie. The doctors called me when Manie arrived and told me Manie had transposition of the great arteries.

I was told that Manie had to have a procedure done to save his life. The doctors went through the artery on the inside of Manie’s right leg. The doctors snaked a balloon all the way through the artery to Manie’s heart. Once the doctors were in Manie’s heart they blew the balloon up and ripped a hole in Manie’s heart.

In the days following the surgery Manie’s leg and foot started to turn a dark purple. The doctors told us that Manie may have to have his leg amputated because the procedure damaged the artery in Manie’s leg.

Right before Manie’s open heart surgery the doctors put Manie on blood thinners. Shortly after putting Manie on blood thinners they were able to detect a pulse in Manie’s foot. Manie kept his leg.”

That’s just the start of Manie’s story – he’s three now and still having to have operations.

Please look in on Julie’s blog and give her and Manie all your support – big pharma victim

Seroxat and the Foetus

Glaxo admits that Seroxat can double the risk of heart defects and other malformations in babies born to Mothers ingesting Seroxat during pregnancy. This has been well documented already and the FDA and MHRA have issued warnings recently about the risks to newborns and the unborn.

Seroxat was also recently reclassified from a category C drug to a category D… Which means it does “officially” pose a significant risk to the foetus…

To find out more, I suggest you read Truthman30′s excellent post about this sensitive issue.

What it’s all about…

Sometimes I forget why I do this, but then I remember, it’s not really about big business, drug marketing and corruption – it’s actually about people – people and their stories.

And you will hear the same stories literally the world over. The experiences are so similar it’s frightening. It doesn’t matter if you’re from London or New York; Birmingham or Melbourne; Dublin or Bahrain – if you have had problems taking, or withdrawing from, an SSRI, then people’s experiences will be all too similar.

And how many of us might suffer?

To begin with, withdrawal was not even mentioned on the early Seroxat PILs. Later when it was mentioned on the PIL, it was rare – 0.2%. Then on 25 June 2003 the PIL was quietly rewritten by Glaxo and withdrawal became a likely issue for 25% of patients. Yes from 0.2% to 25% – overnight.

And today the estimate (on the PIL) stands at “3 out of 10″ – that’s 30%. I wonder what the real figure is?

Here are a couple more stories from the testimony given to the FDA hearings last December in America:

My name is Andy Vickery. I am a trial lawyer from Houston, Texas. Many of the people that you have heard from or will hear from, the victims of SSRI-induced violence and suicide, are my friends and clients. I wish they didn’t have to meet me in that way. I wish that I didn’t have to answer the question for them of where is the justice in the “justice for all” when they have lost someone close to them. I am supposed to compress about twelve year’s worth of my professional life into three minutes today, and I don’t know how to do that really, so let me make as many points as I can.

First, Dr. Clayton is right, do no harm — no harm. Don’t balance that you might maybe do some benefit to someone else — do no harm.

Secondly, I have provided you with a written statement that’s called “Needle in the Haystack.” They are not my words. They are the words of Charles Beasley at Eli Lilly in 1990 when they looked at this, and he said: “If you want to see if this is a real phenomenon, don’t look at the clinical trial data. It’s not there. You won’t find it there. It’s like looking for a needle in a haystack because these trials were not designed to measure it.”

What have you done for the last two years?

You have done precisely that, you have looked for the needle in a haystack, in a place where it is not likely to be in the first place. You have looked at a hundred thousand patients, and you have ignored the millions of patients.

Why do you have a MedWatch system? Why did you abandon some years ago the FDA causality algorithm that was used to assess causality?

Assess causality on these “anecdotes.”

These are not anecdotes, and these deaths are neither significant statistically, Dr. Stone, or otherwise.

Why did you abandon the FDA causality algorithm that you used to assess these events when Dr. Temple and Dr. Laughren started with the FDA?

Because if you take the published literature, if you take Anthony Rothschild’s article in `91 that shows akathisia and suicide, and if you subject it to the causality algorithm that the FDA itself used, it will show that it is highly probable that the akathisia and the suicidality experienced by the three patients that these Harvard psychopharmacologists rechallenged was probably caused by the Prozac. That was 15 years ago. Fifteen years ago when this Committee was summoned, the issue was swept under the rug, and a lot of people have died since then. I wonder, as I read the report, why you have been summoned days before Christmas on short notice this year?

The FDA says the Advisory Committee isn’t even going to be asked for advice. You might ask yourself, Why are we being summoned? Are we being used in some way before the change in the Congress in January? What’s going on here?

(Applause.)

MR. VICKERY: In 1991, this gentleman right here (pointing at Committee member) before he became a paid expert for Pfizer and GSK wrote, “From making the cure more grievous than the disease, good Lord, deliver us.”

You deliver us.

and

I am a little vertically challenged here. Good morning ladies and gentlemen. My name is Kimberly Porto. I have asked my parents Barbara Bedina and Raymond Bedina, and my sister Cara Bedina behind me to join me here at the podium.

On October 9, 2003, my brother Raymond E. Bedina died of Lexapro®-induced suicide after taking Lexapro for only nine days. Ray was just 32 years old when he passed. Those who knew Ray remember his loving, giving personality, his great sense of humor, his warm smile that would take you in and hug you, and his insistence that his friends and his family were more important than anything else. Ray was the kind of brother, son, and friend you felt lucky and proud to have. He was successful at everything he tried. He excelled at his career and he excelled at life. Ray was prescribed Lexapro by his primary care physician for fatigue associated with anxiety. He had no history of depression or any other mental illness.

At the time he was prescribed Lexapro Ray was feeling stressed about work, but only because the current demands of his job were not allowing him to spend as much time with his family and friends as he would like. He was becoming concerned that he hadn’t had the opportunity to settle down and start a family as many of his close friends had at that point in time.

Within a couple of days of starting Lexapro, Ray began to experience very unpleasant side-effects. When his coworkers and friends noticed that he was not himself and not feeling well and asked him what was wrong, he told them that he had recently began talking a new medication called Lexapro and that he felt that it was making him feel ill.

Within five days on Lexapro, I noticed my brother pacing back and forth through my house, uneasy, agitated, and anxious. His hands were shaking. We knew something was wrong. Only in retrospect do we now understand that what he was experiencing was an adverse reaction to the drug Lexapro. The next day Ray told a friend that he thought the Lexapro was making him feel weird, and he had very strange thoughts running through his mind. Within seven days of taking Lexapro, Ray was thinking about suicide. He expressed thoughts about hurting himself.

Two days later, he went to a hotel alone. He never said goodbye to anyone. My sweet, loving brother who had always sought peace and expressed strong views against suicide and violence ended his life by cutting himself with a knife and poisoning himself with pills.

Ray died alone.

I am sure that he was also very scared and very sick. My brother never should have suffered and died that way. Over the past fifteen years, too many tragedies like this have destroyed too many lives. Too many families, like ours, are broken and struggling every day with the pain and anguish of losing a loved one in this horrific manner. My brother and his doctor deserved to know the truth about the suicide risk associated with Lexapro. Had Ray and his doctor been warned that Lexapro can cause the emergency of akathisia and suicide, Ray would be here with us today, and my family wouldn’t have paid the ultimate price for your failure to warn. The American people have a right to know that SSRIs can cause suicide, and that holds true regardless of whether you are age 5 or 75.

We have a right to make informed decisions.

Cymbalta marketing by the back door: re-post

I’m going to keep bringing this little story to everyone’s attention in the hope that I can get a response from Jim Thomson who has been involved in grassroots patient groups for many years. In fact I think that Jim may have taken over as CEO of Depression Alliance from Rodney Elgie. (More on Mr Elgie here)

Also I notice over at Seroxat Sufferers, Bob Fiddaman promises some new developments in this story – see his post here.

So here’s the re-post once again:

I wrote a post recently to bring everyone up to speed about a discussion that had been going buried deep in Seroxat Secrets on the comments section of an older post (if you follow…?)

I’d just like to focus on one point of detail that might help people to understand why I think the way that I do. In another related post, I wrote about a specific booklet that had been produced to support National Depression Week 2005. This campaign was themed ‘Pulling Together’ and was described by the Charity (Depression Alliance) like this: “The 2005 campaign highlights one of the most remarkable and positive aspects of the condition – how people pull together to defeat the illness.”

All well and good. My point – one which I feel I have demonstrated in great detail – is that I think that the booklet had very little to do with ‘Pulling Together’ as described by Depression Alliance and rather more to do with “increasing awareness of the established link between depression and somatic symptoms such as general aches and pains, and to improve recognition among journalists of general aches and pains in depression.”

You can read my critique and see what you think – I was however firmly put in my place by a comment from Jim Thomson, who used to be the CEO of Depression Alliance:

“I apologise for not addressing your point about “Pulling Together” and have just spent time re-reading it (in fact I’m not even sure if i was still with DA when it was published, but I may have been.) I have also been reading your critique of it, which is conspiracy theory of the first water. I doubt I can convince you of this, but I can assure you that the research was undertaken for very different reasons than those you assume.

For some time, many of us working in mental health, had become concerned at how depression was being viewed within the DOH. You might not know that the illness was not even included in the GP GMS contract – effectively dis-incentivising GPs from diagnosing it. You most certainly won’t know that in a recent re-shuffle, there wasn’t even a Minister with responsibility for mental health until I telephoned the DOH and told them than it might be an idea to correct the ommission before I contacted the media. It seems that they “forgot” about mental health.

This de-construction of depression looked to us to be very deliberate. The illness was not (and is still not) classed as an SMI (serious and enduring mental illness – which is where all the DOH funding goes.) This is convenient because if GPs actually diagnosed all of the undiagnosed depression in this country, the NHS would be in worse shape than it already is. The reason GPs don’t diagnose early, is that they often don’t realise that patients are presenting with the physical symptoms of depression.

Again this backdrop, a piece of research was planned, to try to underline that somatic symptoms are (or can be) very much a part of the illness. That was the strategy – it had nothing to do with Cymbalta. You can take my word for that or not – it is immaterial to me because, whether or not it satisfies your concerns, it is the truth. If you want to ake it further, then take the matter up with the ABPI – and before you counter that the ABPI is an industry body, I would remind you that they have suspended, I believe, at least three of their big pharma members in the past year, for the sort of activity you imply.”

As per Jim’s description of the research brief, I’m still a bit hazy as to where the ‘Pulling Together’ concept fits in – you know …”highlights one of the most remarkable and positive aspects of the condition – how people pull together to defeat the illness.”

Also Jim states “That was the strategy – it had nothing to do with Cymbalta. You can take my word for that or not…” In which case I think maybe Jim ought to read this, from the Healthcare PR agency Packer Forbes:

“National Depression Week for Eli Lilly’s/Boehringer Ingelheim’s Cymbalta

National Depression Week is held annually by Depression Alliance, the leading UK charity for people with depression. The 2005 campaign, Pulling Together, which highlighted how people pull together to defeat the illness, was co-sponsored by Lilly and Boehringer Ingelheim.

The aims of the campaign were to achieve increased awareness amongst healthcare professionals and patients of the established link between depression and somatic symptoms such as general aches and pains, and to improve recognition among journalists of general aches and pains in depression.”

Packer Forbes clearly link national Depression Week directly with Cymbalta and clearly state the aims of the campaign.

Packer Forbes worked with Depression Alliance on the research and the campaign for Pulling Together. Packer Forbes also worked for Eli Lilly & Boehringer Ingelheim on the UK launch and marketing of Cymbalta.

Jim may or may not have been CEO of Depression Alliance when this document was actually published, but clearly he was CEO when the booklet (and entire campaign) was being written, designed and approved for production.

So the question remains – why?

Why was the aim to increase awareness of the established link between depression and somatic symptoms such as general aches and pains, and to improve recognition among journalists of general aches and pains in depression?

Maybe – just maybe – because Eli Lilly & Boehringer Ingelheim had Cymbalta to launch and sell in the UK – the first (allegedly) antidepressant/painkiller combo?

Maybe? – or is all this just a conspiracy theory of the first water [sic]

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