Priorities of Drug Regulators

Regulation: A rule designed to control the conduct of those to whom it applies. Regulations are official rules, and have to be followed...

Unless of course you are part of the team at Health Canada, the FDA or the MHRA, it seems.

Exactly what 'regulations' are put in to place at the three regulatory drug bodies above?

One would assume that they regulate the drugs people take but are they merely regulating the drugs that people make as opposed to regulating the pharmaceutical companies that make them?

Quite a bold question but all will become apparent in this latest rant of mine.

A story has just surfaced on CBC News, Canada, that is quite alarming. Although it centres strongly on Health Canada and the FDA it is quite conceivable to rope the MHRA in too.

The story centres around the sale of cheap drugs on the Internet and how online Canadian pharmacies are cashing in on this booming trade. One has to question Health Canada for overseeing this. Basically, drugs are cheaper in Canada than the US, so they make an awful amount of money by selling drugs online to the Americans. Paxil, Zoloft, you name it, they are all there.

Now things are at a delicate stage where the whole SSRi withdrawal protocol is concerned. As I understand proposals have been put forward to the BNF to amend the wording regarding withdrawal from SSRi's and the MHRA did promise me that they would meet with David Healy to discuss a tapering programme. As yet, no meeting has been secured. Anyway, I did tell the MHRA, or at least their former communications officer, that just because I had met with them it would not mean that I would stop writing about them if something niggled me and I thought it was newsworthy. I'm beyond lambasting individuals that work at the MHRA but will call Kent Woods, the CEO, to task if I think they are not doing their job properly. The buck, after all, stops at the head honcho does it not?

Anyway, I digress.

Today's rant sees me homing in on online pharmacies and how they are regulated. These, however, are not the pharmacies selling obesity, anti-baldness or erectile dysfunction drugs. These are online pharmacies that are selling popular drugs such as Paxil and Zoloft.

Late last year the MHRA teamed up with pharma giants Pfizer and made a special advertisement that was aired throughout cinemas here in the UK. The crux of the message was don't buy your drugs online. It was plainly obvious that Pfizer's Viagra was the subliminal message behind this footage.

I'm all for stamping out fake drugs but I am also all for regulating the 'proper' drugs we take too. It seems the MHRA, FDA and Health Canada much prefer to home in on the illegal sale of drugs over the Internet rather than the regulation of pharmaceutical drugs... that is after all their primary role is it not? They may argue that stamping out fake drugs is also a role of theirs - my argument is that it seems to be taking precedence over a much bigger problem!

The U.S. Food and Drug Administration's [FDA] official line on buying drugs over the Internet is if you're an American buying drugs online, you could be paying for:

Counterfeit drugs.

Medicine that's too strong or two weak.

Drugs made in unsafe conditions.

Drugs that are beyond their best-before date.

----

Two arguments that are both feasible here:

1. The regulators have to protect the public safety so monitor fake drugs over the Internet, coming down hard on those that are caught.

or

2. The regulators are merely protecting the pharmaceutical industry who see small online businesses as competition.

The regulatory authorities are funded by pharmaceutical companies, in other words, any drug that comes through the door needs investigation by the regulator to see if it is safe and effective. Pharma pay for that investigation process. Unfortunately, many bad drugs have slipped through the system and onto pharmacy shelves because the regulators have had the most important data kept from them... by the very same people who have paid them to 'investigate the data!'

There is no conspiracy here. This is fact.

Two stories highlighted on this blog only yesterday is testament to that fact. [1] [2]

The FDA says there's nothing wrong with buying online, as long as the website is located in the United States, is licensed by the state board of pharmacy where the site is operating, has a licensed pharmacist on hand to answer your questions and requires a prescription from a doctor who is licensed to practice in the United States.

So, in essence, if any website meets the above criteria then it's okay to order... or at least be diagnosed with an illness that they just happen to have the cure for.

Question I have for the regulators - Why is this allowed to happen and why are you not making waves to stamp out this problem?

One would have thought that pharma would have been right behind you financially?

One has to take a step back and look at the bigger picture here.

Online pharmacies that are selling the likes of Paxil and Zoloft are, in the main, making money for pharma. Online pharmacies that sell anti-baldness, obesity and erectile dysfunction pills [of which there are many] are fleecing the pharmaceutical companies because they are much harder to regulate.

The FDA, MHRA and Health Canada should get their priorities in order if they want us to believe that they are looking after the welfare of the public. Too many drugs are slipping through their own 'robust' regulatory system and into the mouths of men, women and children. These same drugs [granted a licence by the regulators] are causing heart attacks, severe adverse withdrawal reactions and in some cases death! Far more than any online 'entrepreneur/s' who is/are selling fake tablets.

Yes, it's wrong to sell bad drugs. It is also wrong to grant a licence to bad drugs. Something Health Canada, the FDA and MHRA have done time and time again.

Face it, their reporting systems are out of date and largely ignored because to actually believe that a drug that they licenced in the first place is causing harm to an individual or individuals would show how flawed the regulatory system is.

Meantime, doctors prescribe us drugs such as Paxil [Seroxat], Zoloft, Vioxx, Seroquel, Lexapro and a whole host of others. Drugs that have been 'investigated' with money given to the investigators by the very same people who manufactured the drugs!

The regulatory systems in the USA, UK and Canada ARE NOT robust. Far from it.

Just ask the parents of any child who has died as a result of the regulators granting a licence to a drug that killed them, ask the grieving widow of a husband who killed himself as a result of SSRi use.

I get no satisfaction out of pulling up regulators for their failures, I just get a sense that they might one day listen to what the patients have to say rather than protect what pharma have to sell.

The Industry [pharma] commit the crime, the regulators aid and abet it.

It really is as simple as that.

Fid

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GlaxoSmithKline Misleading [Again!]

Source: CNN Money

The U.S. Food and Drug Administration said a GlaxoSmithKline PLC (GSK) television advertisement for its Avodart prostate-shrinking drug last year was misleading because it overstated the drug's effectiveness.

In a warning letter to the U.K. drug giant posted on the agency's Website Thursday, the FDA said a 60-second spot titled "Planetarium" presented " misleading comparative claims and overstates the efficacy of Avodart." The drug, which had $738 million in worldwide sales last year, is approved to shrink enlarged prostates in men, and to improve associated symptoms and conditions such as urinary retention.

The commercial featured models of planets - including a big one and small one - meant to illustrate the shrinking of an enlarged prostate. An actor says in the ad that Avodart is "different because over time it actually shrinks the prostate, so I go less often. Other medicines, they don't treat the cause, because they don't shrink the prostate."

The FDA said the ad suggests that Avodart is the only medication that shrinks the prostate, but this isn't the case. The agency says Merck & Co.'s (MRK) Proscar, which is also available from generic manufacturers, reduces prostate volume.

Also, the FDA said there was nothing in Avodart's prescribing label to suggest any specific advantages over other products. The agency isn't aware of any comparative clinical trials to support Glaxo's claim that Avodart is superior.

The FDA has asked Glaxo to immediately stop dissemination of these types of promotional materials.

GlaxoSmithKline spokeswoman Sarah Alspach said the ad ran from March to September of 2008, and won't be aired in the future.

"GlaxoSmithKline is committed to responsible marketing of our medicines," she said. "We are making every effort to ensure that future advertising for Avodart integrates the direction provided to us by the FDA."

Fid

Hat tip - The Truthman

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AstraZeneca Seroquel Studies ‘Buried,’ Papers Show

Just In - Source: Bloomberg

Unfavorable studies about the antipsychotic drug Seroquel were “buried” by AstraZeneca Plc, according to an internal e-mail unsealed as part of litigation over the medicine.

Another shameless cover-up by another pharmaceutical company.

"Lawyers for former Seroquel users contend that AstraZeneca knew of Seroquel’s risks years before the FDA required a stronger warning."

Oh so familiar story huh?

Full Story HERE

Fid

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Another Drug Maker Is Accused of Fraud!

Hat tip: Stuart Jones.


Source New York Times

The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.

In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.

Ring any bells?

FULL STORY HERE

Fid

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Feds probing Emory, professor on research grants

Source: The Atlanta Journal-Constitution


By CRAIG SCHNEIDER

Federal officials are investigating Emory University and one of its prominent researchers to determine if either misled government agencies about the psychiatrist’s high-paying work with drug companies, officials said.

U.S. Sen. Charles Grassley, who pressed for the investigation, sent a letter Tuesday to the inspector general of the U.S. Department of Health and Human Services outlining his concerns. He said Dr. Charles Nemeroff, an internationaly prominent psychiatrist, may have violated conflict of interest rules surrounding several grants that Emory received from the National Institutes of Health. Grassley’s letter also noted that Emory is required to report such conflicts to the NIH.

The investigation by the inspector general focuses on the concerns addressed in Grassley’s letter, said Jill Kozeny, spokeswoman for Grassley.

The probe also reflects concerns about the way in which Emory handled the reporting of Nemeroff’s earnings from drug companies and his potential conflicts of interest.

Nemeroff, an internationally known expert on depression and former chairman of Emory’s psychiatry department, was a prime target of Grassley’s congressional investigation into whether drug company payments to doctors and academics compromises medical research and scholarship.

Grassley, an Iowa Republican who is the ranking member of the U.S. Senate Finance Committee, released documents last fall indicating that Nemeroff reported little of the money he earned through speeches he delivered for drug companies. He also received payment from drug companies whose products he was evaluating, officials said.

“But I have learned from the NIH that it was generally not aware of Dr. Nemeroff’s conflicts until I made the issue public last fall,” Grassley said in his letter.

Grassley also requested that the probe focus on whether Emory misled the NIH about the nature of Nemeroff’s talks for the drug company GlaxoSmithKline, which produces the antidepressant drug Paxil. Grassley has asserted that these talks were to promote the drug, while Emory has said they were for general education.

The NIH, an arm of the federal health and human services agency, requires universities to report potential conflicts of interest to ensure unbiased research.

Schools that violate the policies can face fines, a freezing of funds and loss of future grants. Overall, the NIH awarded Emory more than $251 million in funding last year — 61 percent of its total research grants.

As a result of its own investigation, Emory in December stripped Nemeroff of his department chairmanship and placed severe restrictions on his activities. Emory found that Nemeroff had violated the university’s policies by not reporting more than $800,000 in income from speeches for GlaxoSmithKline.

Nemeroff could not be reached for comment Thursday, but he has said, according to school officials, that he believed he was following school policy and was not required to report the speaking engagements.

Emory spokesman Ron Sauder said, “Emory has been fully cooperative with the National Institutes of Health and Sen. Grassley, and we will continue to be.”

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RETHINK

Nice to see a patient support group state that it has known for a long time that anti-depressants are being over prescribed and millions with depression are not getting access to the psychological therapies that could really help them recover.

This after RETHINK had learned of a study which showed that anti-depressants don’t have any clinically significant effect in most cases [1]

Rethink’s Paul Corry said:

“This study shows just how vital it is that NHS spending starts to match up with NICE guidelines. The doctors, the patients and campaigners like us have been telling government for years – spend NHS money on talking therapies and don’t just pour it into drugs. Some people do benefit from anti-depressants but they want talking therapies too. We need to get well-trained therapists ready to start delivering the services people need to get better."

“It is great news that there is going to be more cash for talking therapies but we do need to make sure that talking therapies are available to everyone who wants them, that includes people with severe mental illness, not just mild to moderate depression."

“Rethink and the University of York are launching a brand new service with Stoke Primary Care Trust that will see access to psychological therapies increased right across the area. This exciting initiative, the Healthy Minds Network, will finally enable GP’s to give their patients the services they know will benefit them.”

1 Kirsch, Deacon, Huedo-Medina, Scoboria, Moore and Johnson (2008) Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration PLoS Med 5(2): e45. Doi:10.1371/journal.pmed.00050045

Rethink is a campaigning membership charity working with people with severe mental illness, their carers, families and friends through a network of mutual support groups around the country.

Fid

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'The John Dunbar Theme'

Browsing through some CD's today and came across the soundtrack to the movie 'Dances With Wolves'. I was never a big fan of the movie but always liked the music featured in it. This one in particular, 'The John Dunbar Theme'. It's simply beautiful.

Enjoy.

Fid



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Vaccine Nation

Source: http://www.vaccinenation.net/

At the end of the eighteenth century, British physician Edward Jenner, with highly questionable medical credentials, initiated the theory and practice of live virus immunization that continues to serve as the scientific basis for the ever increasing vaccination of the world’s citizens. With the number of vaccinations given to infants and children rising, kids are receiving doses of toxic mercury and other heavy metals well above environmental safety levels.

Yet the medical evidence is clear. Mercury, known as thimerosal, and other heavy metal additives are highly toxic and threaten children with neurological damage. The long-term efficacy of global vaccination remains controversial, inconclusive and is suspect in light of the powerful corporate interests, lobbying efforts, and profits associated with a multi-billion dollar vaccine industry..

In his documentary film Vaccine Nation, award-winning investigative film director Dr. Gary Null challenges the basic health claims by government health agencies and pharmaceutical firms that vaccines are perfectly safe. This is one of the most critical questions facing today’s children and future generations to come. If inoculation with a large regimen of vaccines is safe, what can account for the rapid increase in autism and other mental disabilities that are now at epidemic proportions? And why isn’t the sudden onset of neurological illnesses in children being treated as an urgent crisis by our government and medical industries?

Weaving together interviews with many of the nations most expert medical researchers, private physicians specializing in autism, parents of children victimized by immunization, congressmen, vaccination activists, legal authorities and more, Vaccine Nation will awaken viewers to one of the continual perils to the health and future of children.






Fid

Related Links:

Doctors say Gardasil is killing 16-year-old!

Spain Suspends Batch of Sanofi, Merck’s Gardasil

LOLA'S LAND PROMOTING HPV VACCINE

Team to probe vaccine approvals

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Seroquel, Sex And Major Conflicts Of Interest Between AstraZeneca Exec And British Researcher, US Ghostwriter

Phil Dawdy over at Furious Seasons blows the lid on a senior medical official at AstraZeneca responsible for the drug Seroquel who had sexual relationships with a British researcher, who studied the drug and wrote positively of it, and with an American medical ghostwriter, who among other things assisted in writing two published academic papers known as BOLDER I and BOLDER II, in the American Journal of Psychiatry in 2005 and the Journal of Clinical Psychopharmacology in 2006 that were at the heart of Seroquel's 2006 approval by the FDA for bipolar depression. According to court records, there is evidence Macfadden gave one of the women prescription painkillers and exchanged emails with them showing relationship of "control and dependence."

Read the full shocking story HERE

Fid

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In Our Thoughts

Received a rather disturbing email from The Harts today.

Their son [17] has been tapering from Paxil liquid.

Last night his mother, Shelly, found him lying on the bedroom floor, he had swallowed a bottle of pills. He is bleeding internally and is currently in hospital.

My thoughts go out to the Hart family and I sincerely hope their son pulls through.

Fid

**Update - http://shelly-hartheaven.blogspot.com/2009/02/another-teenager-almost-another.html

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Bloggers Hitting The Radio Waves

Congratulations to Gianna Kali who writes the Beyond Meds blog. She has recently spread the word via the radio station, 'Madness Radio'.

Madness Radio: Voices and Visions From Outside Mental Health is a weekly FM show produced through WXOJ-LP in Northampton MA, aired on KWMD in Anchorage Alaska. Madness Radio is syndicated through the Pacifica community radio network and shows are picked up by stations around the country and internationally. The show is also vailable online and through iTunes.

In this intimate interview Gianna bares her soul and tells of her time on prescription drugs, over 30 in all.

It's a very brave thing to do and requires a certain amount of balls [I don't know the female substitute for that saying!]

The interview lasts for almost an hour and can be downloaded HERE. It's well worth the listen.

I hereby dedicate the following song to her. The title 'She's Got Balls'. Forget the lyrics, it is after all AC/DC. I just like the way Bon Scott screams, 'SHE'S GOT BALLS'!

Take a bow Gianna.

Fid

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Anti-depressants: just how safe are they?

Source: The Telegraph

Hard times ahead will see many of us reach for anti-depressants. But are they safe, asks Victoria Lambert.

When millionaire philanthropist Sir Peter Lampl went missing last week, his family and friends blamed his disappearance on a change of medication. Sir Peter had been complaining that the anti-depressants he was taking, following the breakdown of his marriage, had affected his golf. However, after being issued with a different prescription, he suffered an instant change in his personality, according to his father, Fred Lampl.

"He wouldn't eat and the result of the medicine change is that he left the house without telling anyone," said Mr Lampl. Although Sir Peter is safely back with his family, after being found at Victoria station last Tuesday, his story will have come as a shock not only to the thousands of Britons who take anti-depressants, but also to the many more who suffer from depression and who may have been contemplating seeing their GP for help.

The latest figures show that, in the UK in 2007, there were 34 million prescriptions for anti-depressants, of which 18 million were for a type of drug known as SSRIs, such as Prozac and Seroxat. These figures are expected to rise as the recession bites and people losing their homes, jobs or businesses seek help.

While taking these drugs has become increasingly common, Sir Peter's unfortunate experience highlights serious potential dangers. Are they really safe to take? Is it that in our desire to find a "miracle cure" we are ignoring the risks attached?

Psychiatrist Dr William Shanahan, medical director at Capio Nightingale Hospital, London, is adamant that anti-depressants are safe. "These drugs have their place. They work wonderfully for many people and lives have been transformed by them," he says. He finds the case of Peter Stampl very unusual and difficult to explain without a full pharmaceutical history, but believes such an extreme reaction would probably be brought on by a combination of factors such as a build-up of medication, linked with another illness, stress or alcohol consumption.

"This case may have scared people but these events are rare and often the result of other factors becoming involved," says Dr Shanahan. "You get interactions between substances, which leave the body in a state of toxicity and can create a feeling of confusion. And in this particular instance, there will be variables we know nothing about. It might be something unrelated to the depression."

But Dr Shanahan does warn of the "normalisation" of taking anti-depressants, and that because they are so commonplace, we don't consider the risks. "We are becoming too blasé about anti-depressants," he says.

Alison Cobb, senior policy and campaigns officer for Mind, the national association for mental health, believes that while the normalisation of anti-depressants is a good thing – "depression is more acceptable; the taboo has been lifted" – there is a dangerous gap in public knowledge.

"The names Prozac and Seroxat are so well known," she says, "that perhaps people don't recognise that they are serious drugs with side-effects, and the potential to cause withdrawal symptoms."

She also warns that sometimes the side-effects, such as weight gain or sexual problems can often be felt well before the benefits of the medication. "The medication can take two to four weeks to work – in terms of lifting the depression – but the adverse effects may be felt more quickly."

Historically, drug therapies for depression were opiate-based and addictive. The first breakthrough came in the Fifties, with tricyclic anti-depressants, such as Amitriptyline, drugs that block the re-uptake of certain neurotransmitters (messengers in the brain) such as noradrenaline and serotonin.

But in the Sixties and Seventies, it was Valium that worked, by anaesthetising the brain, and was so commonly prescribed to anxious housewives that it became known as "mother's little helper".

Tricyclics are still used for severe depression, but are associated with unpleasant side-effects, including drowsiness and confusion. But it has been the emergence in the past 20 years of selective serotonin reuptake inhibitors (SSRIs) such as Prozac and Seroxat, and Noradrenaline Reuptake Inhibitor (NARI), such as Reboxetine, that have revolutionised the treatment of depression.

These drugs are more effective and carry fewer side-effects. More than 40 million people are estimated to have taken Prozac – the most well-known SSRI – worldwide since it was approved by the Federal Drug Administration in 1988.

There are real dangers in taking anti-depressants – notably the risk of death. Between 1993 and 2002, there were 4,767 deaths in England and Wales involving anti-depressant drugs, according to the Office of National Statistics.

Seroxat, a widely prescribed SSRI, has been linked to suicidal behaviour among young adults and is being monitored by the Medicines and Healthcare Products Regulatory Agency.

Ironically, the suicide risk can be highest, "just when the patient is beginning to recover and getting their energy back," says Alison Cobb, "but the underlying depression has not been cured. The other danger points for anyone on anti-depressant medication are at the moment they start, when the dose is changed, when the drug is changed, or when they begin withdrawing from taking it."

Cobb warns that serious cases need monitoring, but all patients can help themselves, too. "Get informed about the drug you're offered or taking."

She also points out that drugs are not the only option. The National Institute for Health and Clinical Excellence recommends cognitive therapy, which teaches patients how to change old behaviour patterns, as a first-line treatment for mild/moderate depression. The Government is investing £300 million in increasing access through GPs' surgeries.

Dr Shanahan says: "Anti-depressants provide a tail wind to the plane you fly. They can give you a lift, but you can't expect them to do everything for you."

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Telling clever stories with misleading ads

Source: Healthcare Concerns India

Interesting take on direct-to-consumer advertising over at the Healthcare Concerns India Blog.

The author writes:

Take, for example, a Paxil commercial that was recently popular. At the beginning of the commercial, the typical 30-something-year-old woman is standing outside a house, looking through the window at the happy party going on inside. She looks so lonely and depressed that it must break nearly every consumer's heart. "What's wrong with her?" we compassionate humans gasp in unison. The voiceover answers our question as we think it: The woman has social anxiety disorder, a condition that can be treated with the prescription drug Paxil.

Suddenly, the now-medicated woman rings the doorbell and, with a huge smile on her face, joins the party. We see how much fun she is having and we are so happy for her! Of course, the voiceover quickly goes through the list of Paxil's potential side effects, but how can we concentrate on that, when we're so busy rejoicing at the woman's new happiness? Whoever wrote that commercial should write Hallmark movies. After seeing it a few times, I was convinced that most of my non-immediate family had social anxiety disorder and I even called one relative up to suggest that she take Paxil. I'm not even a gullible person, yet I was persuaded by pharmaceutical company advertising.

Doctors prescribe whatever the patient names.

Full article here

Fid

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Virgin Media - A Rant

This is just a typical example of a fucked up Britain.

Yesterday I received 5 phone calls from my cable company.

Caller: Hello, this is Virgin Media, can we have your password please?

Fid: Um, sorry, I'm not going to give any Tom, Dick or Harry my password who claims to be from Virgin Media.

Caller: But we need your password to discuss this matter.

Fid: What matter?

Caller: We need your password

Fid: I'm not in the position of giving you my password, you could be anyone, how do I know you are Virgin Media?

Caller: Okay.

**Hangs up.


This happened 5 times... on a Saturday!


So, I call Virgin Media, I have no problem giving them my password if it is I who calls them.

They can confirm that an outside company now makes 'courtesy calls' to Virgin Media customers to remind them that their bill is due.

I ask when my bill is due.

March 10th Sir, they tell me!

18 days away!



Fid

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It really wouldn't surprise me!

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A ramble and a rant.

It seems many bloggers write about personal stuff on their blogs where posts are otherwise reserved for highlighting the dangers of the drugs we take. I've been careful to try and keep on track due to the obsessive simpleton who stalks my every move [word]. No doubt a post will soon appear on his doppelganger blog labelling me a whingeing bastard or something along those lines. Anyway, enough about that particular moron, I would hate to be the one responsible for staining the front of his pants because he seems to 'get off' when his name is mentioned.

Today, I filled in... or should I say, 're-filled', a claim for Incapacity Benefit. In their infinite wisdom, probably with some persuasion by some Northern Irish prick, the Benefits Agency sent me a form to fill. I've been on Disability Living Allowance for some years but this, apparently, means nothing. Ho hum, I thought, this should be a barrel of fucking laughs.

What is your name?

They sent me the bloody thing!

Please tell us about your illness or disability.

Would any of their highly paid doctors know about prolonged use of an SSRi, my guess is that many of them would have to look up what an SSRi actually was!

Do you think any of your problems are linked with drug or alcohol abuse?

Yes... but Pharma and the books your doctors tend to read will dispute this!

The next section applies to sitting, getting up, bending and kneeling. It's here where you get to tick a selection of boxes. However, there is no mention of the frequency of how and when these 'problems' occur. One is left to estimate.

The boxes:

1. I do not have a problem with sitting

2. I cannot sit comfortably at all

3. I cannot sit comfortably for more than 10 minutes, without having to move from the chair.

4. I cannot sit comfortably for more than 30 minutes, without having to move from the chair.

5. I cannot sit comfortably for more than one hour, without having to move from the chair.

6. I cannot sit comfortably for more than two hours, without having to move from the chair.

----

I was actually laying down whilst filling the form in, incidentally I had to send the original form back and request one with a much bigger typeface - unfortunately my left eye is shot and I need reading glasses - I cannot afford them.

So, assuming that the 'patient' answered the above question truthfully we have to assume that those that read and vet these applications are already there with red pen in hand to draw a red X through any discrepancy.

I actually made a comment that I was laying on the floor whilst filling the form in, I added it to a comment section where you give the Benefits Agency 'further information'

The form took about 45 minutes to complete so one would assume that the folk with the red pens would immediately be alerted to anyone who had ticked boxes 1,2,3 and 4.

I actually do have difficulty sitting on a chair, those that know me will know my back has been playing up lately as is my right hip. I refuse to take treatment in the form of Pharma tablets until it gets so bad that it makes me want to vomit. This past month I have wanted to vomit with the pain.

When readers of Seroxat Sufferers read my posts they probably envisage me typing away like a madman. Sorry to disappoint, it takes me quite a long time to post as more often than not I have to rise from my chair because when the hip pain kicks in it hurts like a bitch. I was diagnosed with Bi-Lateral Osteoarthritis when I was 35. Because of bureaucracy and probably money, The Royal Orthopaedic Hospital here in Birmingham deemed me too young to have a hip replacement. I'm 44 now, still no call from them.

Apparently it costs between £8,000 - £15,000 to have a hip replacement, this replacement lasts for up to 12 to 15 years. So I guess it makes sense to give a replacement to a male aged 70 because more than likely the chances of him dying before he needs another replacement are higher than that of someone who is 35. That's the brutality of it!

Politics at its best folks.

Anyway, the form has been filled and I have told the Benefits Agency that I have no intention of parading around in front of them, bending over to touch my toes or stretching my arms in the air so one of their doctors can make an assessment of whether or not I suffer with pain.

More importantly, I think so anyway, I have told them that if they wish to send me to see one of their highly paid doctors then I want the said doctor to be clued up about SSRi withdrawal and long term use of SSRi's and its effects on the humans taking them.

They won't be able to offer me such a doctor because no doctor has been trained in this field, at least not in the UK. Take that as a given.

I therefore offered them my services and told them that when they 'assess' depressed people they may be witnessing something that they have never come across before - they may be witnessing SSRi withdrawal.

If they want me to help them understand this then they can call me and request to see me. If they want me to discuss it with them on a patient/doctor basis they can kiss my ass - but they will have to do the bending.

Rant over.

Newsflash. My Internet stalker has just been spotted buying bleach to take away the stain from the front of his jeans.

Fid

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FOR BON

29 years ago, yesterday.

You were The Man, The Rocker.

Thanks for the memory.

Rock In Peace.



THE ROCKER
A man of precocious wisdom
Was Ronald Belford Scott.
Mr Double Entendre,
Mr Double Bourbon Shot.
A man so warm and friendly
A lyrical prodigy
Oozing stage presence
And sweating energy.
He started with The Spektors
For whom he played the drums.
Then The Valentines & Fraternity
'Til uniting with the Young's.
A partnership was born
AC/DC was their name
Australia's biggest export
Is what these lads became.
In February 1980
My world came tumbling down.
Bon had been out boozin'
In London's Camden Town.
He died all alone that night
In the back seat of a car,
The greatest Rock 'N' Roll singer
A special Rock 'N' Roll star.
Bon will always be with me
In my memory he will stay.
Rest In Peace, Dear Bon,
Until we meet some day.

© BOB FIDDAMAN

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"I didn't just cross a line I tripped over an edge": Experiences of serious adverse effects with selective serotonin reuptake inhibitor use.

"The accounts we report cast a shadow of doubt on the rhetorically powerful, but ultimately un-testable, 'disease not the drug' claim."



Many thanks to one of my readers and close friends who sent me the following paper.

It's from the New Zealand Journal of Psychology Date: March 1, 2008 Author: Liebert, Rachel; Gavey, Nicola

Abstract:

Evidence that selective serotonin reuptake inhibitors (SSRIs) may elicit suicidal and/or aggressive thoughts and behaviours has been circulating for nearly thirty years. Despite a growing body of knowledge around these serious adverse effects, however, they continue to be surrounded by controversy. In particular they are subject to (arguable) counter-arguments that any risks from using the drugs are outweighed by benefits and/or more attributable to a person's 'underlying disease'. Moreover assessments of risks often use rates of completed suicides as the ultimate measure. In this paper we draw on people's own accounts of their experiences of serious adverse effects associated with SSRI use. In depth semi-structured interviews were undertaken with nine people who had either used SSRIs themselves or had witnessed the use of SSRIs by a close family member. We present four themes identified across the interviews relating to adverse effects from SSRIs: experiences of akathisia, aggression and suicidality; 'out of character' behaviour; harm to relationships; and accounts of responses from the medical profession. Participants reported that the experience of adverse effects had marked impacts on general wellbeing, identities and relationships. These accounts cast doubt on notions that serious adverse effects associated with SSRI use may stem from an underlying condition and/or be outweighed by benefits from SSRI use. In addition they offer a persuasive and poignant plea to further consider non-fatal adverse effects and their consequences in assessing the risks of these drugs.




The full paper can be downloaded here and provides further evidence to the medicine regulators that we have a huge problem here and the quicker they act upon it, the safer the public will be.

A copy has been sent to the MHRA.

Fid

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Doctors say Gardasil is killing 16-year-old!

Source: ABC News Kake




A Wichita teen and her mother want a popular vaccine taken off the market. Doctors say Gardasil is killing the 16-year-old.

The drug is used to prevent the HPV virus which causes cervical cancer. The makers of Gardasil recommend girls and young women ages 9-26 get the vaccine to protect them from the virus that causes cervical cancer.

Twenty-eight women have reportedly died from Gardasil.

Sixteen-year-old Gabi Swank used to be a cheerleader, a gymnast and a 4.0 student at Wichita's South High, but after getting the Gardasil vaccination last year, her health deteriorated quickly.

She's had two mini strokes, seizures and swelling of all the tissues in her body. She even has paralysis on the right side of her face. After months of testing, doctors finally pointed to Gardasil as the cause.

"I want this drug off the market. I want it off the market," said Swank from her home.

The CDC and the FDA say they have received thousands of reports of adverse reactions to the vaccine, but the government adds, it continues to find that the benefits of Gardasil outweigh the risks.

Gardasil is manufactured by Merck, the same pharmaceutical company that gave us Vioxx, a drug they pulled after a study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo. Here is how they 'promote' Gardasil on their website.






** In the UK, girls are vaccinated for the prevention of cervical cancer with Cervarix, manufactured by GlaxoSmithKline, the same pharmaceutical company who are writing cheques left, right and centre to settle Seroxat/Paxil legal battles. Here's how Lola's Land, a UK based website aimed at children, promote Cervarix.



Fid


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Two faces of GlaxoSmithKline

The face they portray





THE FACE THEY WANT HIDDEN:

All posts are from the Cafe Pharma Discussion Board. A place where Pharma Reps 'hang out' - Looks like the anonymous poster was only a few months out with his 'insider' information!

An honest insider post, the REAL future at GSK..... - 10-29-2007, 11:11PM
http://www.cafepharma.com/boards/showthread.php?t=235617

I have had access to executive level discussions regarding the GSK layoffs. I am posting this information from an anonymous "business center" computer location. I won't say anymore, except that my credibility is legitimate.

I understand that rumor, speculation, and misinformation is running rampant right now through out the entire GSK organization. I feel that the lack of communication with our sales force regarding the true intentions of this company is regrettable. I personally know quite a few of the excellent employees of GSK that will be terminated.

I am dismayed that executive level management has so little regard for the employees welfare. Yes, I remember the Zantac Hawaii trips! This is why I am being honest with you.

GSK is planning a second round of layoffs that will occur immediately before second quarter earnings are announced in 2008. Projected sales forecasts for Avandia family over the next six months are dire.

The current layoff scenario has been structured to appease shareholders and Wall Street analysts.

The layoff in 2008 will be attibuted to the new management team. They hope to be given credit by the Street for taking decisive action in the face of declining revenue. This may shore up the stock price at that time.

So you ask, "Why not just lay every one off now?" There is a good answer. The GSK Senior Executives very closely studied the Pfizer layoff from last year. Do Executives from different companies talk with each other? Yes, they do. Pfizer management noted that after the layoff, a significant portion of the sales organization was demoralized. This resulted in many subsequent resignations as Pfizer sales people found new jobs on their own. This resulted in Pfizer not having to pay these people severance packages. The net: Pfizer saved a tremendous amount of money by having a layoff followed by enhanced attrition.

GSK is planning the same situation. This is why the current layoff in not as large as it really needs to be. Two smaller layoffs is more cost effective than one large one.

I have been honest with you. If you survive the current layoff, there is no guarantee you will survive the next one in June 2008. Plan for your future accordingly.

I realize on Cafe Pharma some people will bash this information as false. However, you might be surprised how many people in VERY senior management read this board. They need to know that some managers still care about the employees. The point is, do what is best for you and your family.

I have to admit, it is sad to see what has happened to this once great company. I really hope GSK can recover, but nothing is guaranteed. Best of luck to all of you.

----

I appreciate you taking the time to post this information. I take everything on Cafe Pharma with a grain of salt, but the scenario you paint seems very realistic.

I hate to do exactly what GSK upper management wants me to do, but if I survive the first cut you can bet I am looking. At this point, I almost hope I get the package.

I think working for GSK next year will be absolutely miserable!

----

I really do hope that I get a severance because for the last 6 months I have only stayed and not looked for another job because of the benefits that GSK offers- good insurance, car, gas, etc.. Just remember, at least 12 weeks of severance which would be 3 months plus 60 days to look for a good job. I will get much more than that which is hopeful if it happens. This job just isn't fun or exciting any longer and if Avandia gets black box then it will be horrible to face the docs that we have called on since the launch of Avandia. I launched the drug and it has been great at times but over the past couple of years it just seems like we were always putting out fires and they were five alarm fires!

----

I was not sure what to think of this post when I first read it. However, talking to a couple of people I know at the home office........these rumors about a second lay off have been floating around.

I would say the information presented here has a fair amount of reliability.........

----

There are many more angry GSK reps over at Cafe Pharma



Fid


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MHRA: Did they fail to prosecute GSK because they feared their own failings?

A recent paper has surfaced via the British Medical Journal Website regarding the four and a half year MHRA investigation into GSK.

The paper, Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity, was written by L McGoey1 and E Jackson 2 and is available through download here [it's a paid service]

Fortunately, I have some very alert readers, one of which sought fit to send me this particular paper in its entirety. Kudos to that person [they know who they are]

For the record, I have sent this particular paper on to both Kent Woods, CEO of the MHRA and Alasdair Breckenridge, Chairman of the MHRA and asked for an official response. Whether I get a response is another matter. I do feel some sort of response would be in the public interest particularly as the MHRA claim to safeguard public health.

It baffles me why the BMJ has to be a paid service because this particular paper should be available to the public for free. I don't blame the authors of the paper here, I'm blaming the BMJ.

The official abstract of the paper [which is free] reads:


This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.

Like many patient advocates, I have been a long time critic of the MHRA, in particular their 'closeness' toward pharmaceutical companies, who, at the end of the day, pay the MHRA's wages. Only recently I highlighted a recent campaign where the MHRA had joined forces with Pfizer to create awareness about the dangers of buying prescription drugs over the Internet.

Many of my readers will know of the GSK/MHRA connection - Chairman, Alasdair Breckenridge is a former employee of GlaxoSmithKline as is Ian Hudson, Head of Licensing at the MHRA.

Hudson, in the main, has remained quiet over the Seroxat debacle. Breckenridge, on the other hand, has been outspoken with his views on Seroxat. Halfway through the GSK investigation, Alasdair Breckenridge told a seminar, "The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish.”

Hardly surprising that Breckenridge would make such a statement. He was after all a member of the Scientific Committee of SmithKline Beecham from 1992 to 1997. What is surprising is the timing of Breckenridge.

To be honest, I see Alasdair Breckenridge as a liability for the MHRA. His arrogance shows utter disdain for those affected by Seroxat. The sooner he resigns his position of Chairman, the better it will be for all concerned. I would, however, like my day with Breckenridge. I would like to show him my own personal timeline [6 years] on Seroxat. "So-called scandal" it most definitely is not and neither he, GSK or their highly paid legal team will ever be able to tell me otherwise.

Anyway, I digress. Back to the BMJ paper.

For copyright reasons I'm not allowed to publish the paper in it's entirety. I have emailed one of the authors to ask his permission but have yet to receive a reply. I can however highlight some points raised in the paper.


In October 2008, the MHRA announced an amendment to the 1994 Medicines for Human Use Regulations. It's basically 'an ammendment to ensure UK legislation is fully in line with existing EU law covering the circumstances when marketing authorisation holders should report new information which might influence the evaluation of the benefits and risks for a medicine to the MHRA.'3

The authors of the BMJ paper suggest that this ammendment became necessary following the MHRA’s revelation, on 6 March 2008, that there would be no prosecution of GlaxoSmithKline for withholding clinical trial data.

McGoey and Jackson briefly explain the reason for this paper but more importantly offer their views as to why the MHRA failed to prosecute. It is something that never really occured to me and has really given me much food for thought. They reflect upon what this episode tells us all about the robustness, or otherwise, of the UK’s regulation of medicines and disect the legal framework which enabled GlaxoSmithKline to avoid prosecution.

The authors also draw attention to the role of the MHRA's funding structure, in particular its need to compete with other European regulators for licensing fees, as well as its wish to evade ‘‘reputational risk’’.4 They deduce that the case of Seroxat and the missing trial data casts uncertainty upon the MHRA’s capacity to fulfil its own ‘‘mission statement’’. 5

Most of the Seroxat Sufferers readers are aware of the history as to why the MHRA carried out an investigation into GSK. In a nutshell GSK submitted papers to the MHRA in May 2003. The papers were 329 and 377 clinical trials which tested the efficacy of paroxetine (Seroxat) in children and adolescents in the mid-1990's.

In early 2004, a confidential, internal GSK document was leaked that indicated that there had been a deliberate decision to withhold Studies 329 and 377 from regulators. The document was dated 1998.

There are Internal documents from GSK down the right hand side of this blog for further reading.

Basically, for five years GSK had witheld important safety information from the MHRA during which time Seroxat became one of the biggest selling antidepressants on the market. In 1999
over 32,000 prescriptions for Seroxat had been issued to children in the UK. In other words, over 32,000 children and adolescents were prescribed a drug that was unlikely to work, and which carried a risk of a serious and probable fatal, adverse reaction. Remember, this is just one year [1999]

McGoey and Jackson state: "We do not know how many, if any, under 18's actually committed suicide between 1998 and 2003 as a result of taking Seroxat, but given the large number of children involved, it is certainly possible that deaths occurred which could have been avoided by prompt disclosure of this information."

There are two high profile cases known throughout Alasdair Breckinridge's 'so called Seroxat scandal' that I have highlighted on this blog many times. Those being the tragic circumstances of Sara Carlin and Sharise Gatchell. Both hanged themselves, both were prescribed Seroxat, both were under 18. It's highly likely to all that had they not been prescribed Seroxat then they would probably be settling down to a Sunday roast with their parents today. If that is defamatory and offends GSK and/or the MHRA then maybe they would like to argue the point with me... or better still, explain to the parents of Sara and Sharise why they were prescribed a drug that carried a risk of death?

McGoey and Jackson's paper is a MUST read and I'm sure it will be available for a free download pretty soon. I'd appreciate it if one of the two authors I emailed would give me permission to publish the paper in its entirety because it is a paper that seriously highlights the failures of the MHRA and begs the question; Did the MHRA fail to prosecute GSK because a high-profile criminal trial would have highlighted their own faults and processes?

For those of you with access to BMJ articles, I strongly recommend that you download the full paper.

Fid

**Amendment - GSK published the findings of study 329 in 2001, but completely repressed findings from two other randomized clinical trials: 377 and 701.

Hat tip: Alison Bass Author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial (Algonquin Books) - http://www.alison-bass.com/


1 James Martin Institute,
Business School, Oxford
University, Oxford, UK;

2 London School of Economics and
Political Science, London, UK

3. http://www.mhra.gov.uk/NewsCentre/CON028540

4. Power M. Organized uncertainty: designing a world of risk management. Oxford:
Oxford University Press, 2007.

5. http://www.mhra.gov.uk/index.htm

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Seroxat and the suppression of clinical trial data: Regulatory failure and the uses of legal ambiguity

A fascinating paper was sent to me anonymously regarding the MHRA investigation into GlaxoSmithKline.

It opens a door that I never really thought about and begs the question:

Did the MHRA fail to prosecute GSK because a high-profile criminal trial would have highlighted the regulators faults and processes?

Extract:

"Seen in this light, it could even be argued that defects in the
regulatory scheme were convenient for the regulator. Instead of
blaming its own structures and mechanisms, or, perhaps worse,
having to face a high-profile criminal trial in which GSK’s
lawyers would skilfully pick over documents, memos and
emails, in minute detail, in order to find fault with the regulator
and its processes, the MHRA has been able to avoid these
threats to its reputational status by blaming shoddy statutory
drafting."

More coming soon.

Fid

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SEROXAT VIDEO - Re-edited

Incompetent?

Liars?

...or just merely kept in the dark?



Fid

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Old GSK Video Resurfaces

This video contains statements made by GlaxoSmithKline official Dr. Alistair Benbow about the antidepressant Paxil/Seroxat/Aropax contrasted with various UK press statements about suicidality and such attached to the drug's use. Was the doctor a liar?



VIDEO HOSTED ON YOUTUBE

For a history of the 'storm' this video caused when it was originally hosted on youtube, read the related articles:


Does GSK Love Bad Publicity? (Clin Psych Blog)
Video sets GlaxoSmithKline Hounds to Intimidate British Blogger (AHRP Blog)
This U.S.A. blog supports Bob Fiddaman (Soulful Sepulcher)
Glaxo Smith Kline (Bipolar Blast)
It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat (Scientific Misconduct Blog)
GSK Lawyers target Seroxat campaigner Bob Fiddaman (Seroxat Secrets)
Tony Nunn
Intimidation: a standard tactic? (Matt Holford)
Glaxo Goes After British Blogger's Video (Furious Seasons)
GSK Video - The Aftermath
Pharmagossip
BLOGSCAN - GSK Lawyers Have Paxil Video Taken Down
Missisyphus’s Weblog: Bob fiddaman’s video about paxil
An Angry Blogger And Free Speech (Ed Silverman of Pharmalot and the Star-Ledger of New Jersey)
Pharma Freaks Out, Fiddaman Under Fire
Coalition Of Parents Enduring Suicide
SSRI Forum: GSK, helping people feel threatened

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Any GSK Whistleblowers?

Workers Group To Fight Job Cuts At GSK In Ware

WORKERS angry at job cuts at GlaxoSmithKline's Ware site are to hold a protest in the town on Saturday.

Threatened employees have organised themselves into a campaign group called the Ware Unite and Fight Group.

According to the Socialist Party website senior shop stewards seem resigned to the planned job cuts, which will see Ware's biggest employer axe 600 jobs at the Priory Street manufacturing plant in a 'restructuring programme'.

It seems that despite union representatives' stance "these workers want to fight".

They plan to leaflet the site and erect a stall in the town centre outside Tesco.

The group has drawn up a list of demands which includes: "no to compulsory redundancies, unite to organise a workplace meeting to listen to the members' views, democratic elections of all shop stewards' positions, and no preferential agreements with outside non-union companies."

They also plan to hold a public meeting on February 18 at The Drill Hall, in Amwell End.

----

Angry folk... they probably have a story to tell about their employers eh?

fiddaman64@blueyonder.co.uk

Hat Tip: The Truthman

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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FOR SARA CARLIN

Some time ago I asked a musician friend of mine to write a song about Sara Carlin.

Here is that song.







You’re Blind

Out of mind, out of sight
It’s now time, to make right
All the wrongs, that you’ve done
She's now safe, but you won

You’re blind lay the blame on her
You’re blind blame it all on her
You’re blind there’s nothing you can do
You’re blind it’s nothing to do with you

She's poor, and you’re rich
But so what, life’s a bitch
Took a chance, with good luck
And you made a fast buck

You’re blind lay the blame on her
You’re blind blame it all on her
You’re blind there’s nothing you can do
You’re blind it’s nothing to do with you

Teenage girl, What she was
Got depressed, just because
Like all kids, of her age
Some things change, at that stage

Of course it's safe for kids, she took the drug to cure her ills
But what she didn't know was she was taking blood stained pills

What are they gonna do
A blind eye deaf ear too
You’re too used, to all this
Ignorance I know’s bliss

You’re blind lay the blame on her
You’re blind blame it all on her
You’re blind there’s nothing you can do
You’re blind it’s nothing to do with you

Time for Health Canada
To get justice for her
GSK and you too
A look at what you do

You’re blind lay the blame on her
You’re blind blame it all on her
You’re blind there’s nothing you can do
You’re blind it’s nothing to do with you



Martin Hetherington 2009

----

Read more about Sara:


Sara Carlin: A life cut way too short... Paxil Suicide


Sara Carlin R.I.P. 21st July


Sara Carlin's Parents Call For Inquest


Canadian Activist Calls For Sara Carlin Support!


Sara Carlin Update


Canadian Activist Speaks Out


More on Sara Carlin Inquest


Ontario: Dr. Andrew McCallum. I salute you.


Concerned Canadian Citizen [Email to Health Canada]

Nessun Dorma - "None Shall Sleep"

Fid

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Premature Ejaculation Pill... an SSRi

Phil Dawdy over at Furious Seasons has an interesting post regarding a new premature ejaculation drug, dapoxetine. Dapoxetine is marketed as Priligy and has just been approved in Sweden and Finland.

Johnson & Johnson hold the patent for the drug - it was sold to them by pharma criminals, Eli Lilly for $65 million dollars and future royalties in December 2003.

Here's the rub [pardon the pun]

Dapoxetine is a short acting SSRi.

So, there is one side effect that pharma have turned to their advantage. Maybe some time down the line pharma will cease the opportunity and create a pill that will give people electric like zaps through their body or maybe a pill that will give the patient the experience of wanting to kill somebody or maybe even themselves!

So we are now led to beleive that dapoxetine will keep the wolf from the door but at what cost?

Premature ejaculation can drive a man [and a woman] insane. I'm guessing dapoxetine will too. I can't wait to see the 'withdrawal' advice on this one!

SHOOT TO THRILL - AC/DC

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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