MHRA's Ian Hudson Grilled Over Clinical Trial Data

Yesterday [Monday 20 October] UK Parliament broadcast a committee meeting regarding Tamiflu, a prescription medicine used to treat the flu (influenza) in people 2 weeks of age and older.

In January this year, drawing attention to the lack of transparency over the results of clinical trials of the antiviral medicine, stockpiled for use in an influenza epidemic.  The Commons Select Committee concluded that the failure of manufacturers to share the full results of clinical trials with doctors, researchers and clinicians, undermined their ability to make informed decisions about treatments and the use of medicines by the NHS.

Yesterdays meeting probed the lack of transparency further.

It's very interesting particularly as we can see Chief Executive of the MHRA, Ian Hudson, being grilled by Richard Bacon, MP. Hudson was asked just one question but seemed very reluctant to give any straight forward answers.

Basically, the UK government have claimed that it would not be feasible for the full methods and results of clinical trials to be made available to doctors and other healthcare professionals.

Ian Hudson was asked why he thought it was not feasible.

The exchange between Hudson and Richard Bacon, MP reminded me of David Brent, a fictional character played by Ricky Gervais in The Office. Brent, when questioned about his management methods was always evasive - Hudson's response to Bacon's question is so very similar. Whereas Brent speaks of pies and charts, Hudson speaks of Freedom of Information requests and policies...without actually answering the question.

Hudson is being really evasive here, just as he was when giving evidence for GlaxoSmithKline in a video deposition back in 2000. [1]  Hudson, was employed as GlaxoSmithKline's World Safety Officer before eventually landing his role of CEO of the agency that protects the public from unsafe prescription medication.

Time and time again he avoids the question put to him by Bacon, time and time again Bacon reiterates his question, leaving Hudson to waffle on in the style of David Brent. You can even see a man and a woman at the back of the room laugh at Hudson's avoidance to answer a simple question.

Kind of ironic that Hudson is being grilled by an MP whose surname is Bacon, doncha think? :-)


Here's the MHRA's Ian Hudson playing David Brent yesterday [Skip to 17.44.46] [LINK]



Just like The Office there is no canned laughter.



Now compare with David Brent.

[1] MHRA CEO, Paxil and Suicide

Bob Fiddaman.

FDA Votes to Keep Warning on Chantix

Despite the protests of the multi-billion dollar pharmaceutical company Pfizer, the FDA have voted to keep the black box warnings on the smoking cessation drug Chantix, known as Champix in Europe.

Only one person of the 11 panel members made up of  the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted to remove the black box warning.

Despite the evidence showing an increase in suicide, aggression and other bizarre side effects  Pfizer's Christopher Wohlberg, MD, PhD, said  "We think the available evidence is inconsistent with a boxed warning."

The panel disagreed and warnings will remain in place.

Below is a video presented to the committee meeting by patient advocate Kim Witczak.

These are actual patient testimonies - something Pfizer should pay heed to.

Bob Fiddaman

Back Stories

Pfizer enters final settlements in 660 Chantix lawsuits

Chantix Class-Action Plaintiff Is Former Pfizer Employee

Passenger Safety - The Champix Scandal

No Advertising Please, Pharma Reps Under Fire.

Pharmaceutical reps, to me at least, have had it their way for far too long... as have the healthcare professionals who accept cash payments, muffins, concert tickets and dinners from them.

Ironically, many of these doctor's profess to have some sort of insight into the brain, often seen prescribing millions of antidepressants because their patients  have some sort of psychological disorder.

What I find astounding is that many of these pill-pushers don't recognise their own psychological disorders, namely living in denial that their acceptance of such gifts makes them prescribe more pharmaceutical wares.

Now, a new campaign is under way to stop the pimping of pharmaceutical wares to healthcare professionals.

“No Advertising Please” was conceived by Dr Justin Coleman, a General Practitioner and President of the Australasian Medical Writers Association.

The campaign is trying to encourage doctors to avoid using drug representatives as their ‘educational’ resource, by pledging to not see drug reps at their practice for one year. Healthcare professionals are being encouraged to add their names to this initiative by signing 'The Pledge' on the “No Advertising Please” website.

It's predominantly Australian based but is receiving worldwide attention.

So, what do medicine regulators think about all of this?

Well, the Australian medicines regulator, Medicines Australia, have taken the unusual step of issuing their thoughts on the whole campaign.

Health journalist Melissa Sweet is reporting that Medicines Australia have issued their own press release stating that...

“…the idea that you can ignore information from a pharmaceutical company that has conducted extensive research and development to help treat disease is laughable at best and negligent at worst,”

Once again we see a medicines regulator with its tongue down the rear end of the proverbial pharmaceutical trousers. Hardly surprising given that global medicines regulators are made up of former pharmaceutical employees. One only has to look at who is in charge of the British drug regulator to understand how this mafia-type industry operate.

Dr Ian Hudson is head of British drug regulator, the MHRA. He was the former World Safety Officer at SmithKline Beecham (GlaxoSmithKline) - He even gave evidence (if you can call it that) defending Glaxo and their antidepressant Paxil.

You can watch part of his performance in the video below.


Hudson's video deposition and involvement in the concealment of the Paxil suicide link can be seen around the 19 mins 50 second mark.

“No Advertising Please” is a great concept and it's taken a clash of conscience to get the ball rolling no doubt. It's going to take more now from healthcare professionals to get on board the campaign and to refuse those latte's and sandwiches from the traveling pharmaceutical reps who have had conscience removed by heavy-handed tactics of pharmaceutical managers.

Pharmaceutical reps push products on doctors in efforts to fatten their own bank balances and not to help patients... of course, I'm generalizing here, some reps do have a conscience, we normally see this with whistleblowers who refuse to promote unsafe drugs anymore, they are usually threatened with dismissal so, in turn, blow the whistle on the off-label promotional practices of the pharmaceutical companies. Some would suggest that these whistleblowers have, themselves, been paying doctors to promote drugs...but here's the rub - they decided enough was enough, they decided that what they once did was wrong. Yeh, a whistleblower can reap the rewards of any such lawsuits against their employers but it's not an easy ride. More often than not they are lambasted by fellow reps and left penniless during the lengthy process of Qui Tam litigation. They'll also find it difficult to find work in the pharma field during any such litigation due to their employers refusing to give them references or, worse still, laying down poison to any prospective employer.

It was notoriously difficult for members of the Mafia to leave - particularly if they threatened to 'spill the beans' on how the organisation was run. The pharmaceutical industry is your modern day Mafia. Bribery, corruption, death and concealment of unsafe products.

Moreover, we have medicines regulators, like Medicines Australia, coming to the aid of the industry when they feel threatened that drug sales will slump as a result of any outside action.

The medicine regulators wrap the pharmaceutical industry in cotton wool, they put an electrical fence around them that protects them from any outside interference. They then sit back and police unsafe drugs made available to the public via websites designed to make a fast-buck on erectile dysfunction problems. "These drugs are not fit for human consumption", they cry. Dig deep and you will find that they are only protecting the pharmaceutical industry. They also do it with natural supplements that lay claim that their product can, for example, 'keep depression at bay' or 'keep your cholesterol levels in check'.

Medicines regulators, I believe, are just as bad as the pharmaceutical industry. They are part of the problem and will feel threatened by the 'No Advertising Please' campaign. What could be a bigger threat to an agency than doctors not prescribing drugs based on a chocolate muffin feast?

Scouring through the thousands of pharmaceutical documents that I've been privy to over the years has seen a smooth operation fueled by greed. Most doctors will be unaware that their prescribing habits are recorded by the pharmaceutical industry, they know exactly how many scripts doctors write for each of their products. When a doctor is not seen to be prescribing their particular brands they up the ante, usually in the form of a lavish dinner for the doctor.

Pharmaceutical reps are trained to learn everything about the doctors on their patch. How many children they have, what their wives names are, what their pet dog is called. They do this to strike up a relationship with a doctor, a personal relationship. 

Those doctors who believe their reps are decent folk who always remember minor details such as family members ("Hey, how's your wife, Cathy and the kids, Ron, Deb and Jack?") will be unaware that they are trained in such psychology. "Get to know your doctor on a personal level and he will warm to you, this results in the doctor prescribing the drugs you promote to him."

As for Australian regulators, well, I've had run-ins with them before. 

Some ads for Paxil (known as Aropax in Australia) appeared on the website of the Delphi Centre in Australia. These ads ran counter to the law in Australia which does not permit direct-to-consumer advertising of pharmaceuticals. 

I wrote to the TGA [Australia's regulatory agency for medical drugs and devices], told them and they gave me assurances that the Paxil ads had now been removed from the website. Thing is, the ads weren't removed.  Here's how the Delphi Centre's webpage looked back in 2007.

it took some weeks before the ads were taken down.

For a Pom to bring it to the attention of Australian drug regulators must have been a tad embarrassing. If they can't regulate their own back yard then what hope do we have?

Medicines Australia can, if they so desire, criticize the efforts of the 'No Advertising Please' campaign. I love the fact that they are because it highlights how tied to the industry they are.

It also highlights how they, along with other global medicine regulators, just want to keep the money-making Pharmafia machine ticking over, regardless of unsafe drugs that disfigure and kill people.

The No Advertising Please Campaign webpage is well worth the read, even if you aren't a doctor.

For anyone reading this it may be worth writing down the url and urging your own doctor to take the pledge.

noadvertisingplease.org

Bob Fiddaman

**Update

I've just been informed that Medicines Australia aren't even a regulator. Begs the question why they are sticking their noses in.

Apathetic Attitudes and Antidepressants

 The Creation

By determining where Abraham fits into history chronologically and adding up the ages provided in Genesis 5 and 11, it becomes apparent that the Bible teaches the earth to be about 6000 years old, give or take a few hundred years. [Source]

This has NEVER been proven.


Cave Drawings

The artworks are in a rural area on the Indonesian Island of Sulawesi.

Until now, paintings this old had been confirmed in caves only in Western Europe.

Researchers tell the journal Nature that the Indonesian discovery transforms ideas about how humans first developed the ability to produce art.

Early artists made them by carefully blowing paint around hands that were pressed tightly against the cave walls and ceilings. The oldest is at least 40,000 years old. [Source]

Below we can see evidence that substantiates these claims [Fig 1]

Fig 1

People, despite this obvious flaw in the Bible and its teachings, still purchase copies of the Bible and live by its teachings. The Bible has reached millions of people the world over. In fact, we now know that the earth is millions of years old, at least 4.5 billion years.

The Chemical Imbalance and Depression

During the 1990's Americans were submitted to heavy marketing by the pharmaceutical industry by the means of  television commercials for antidepressants that claimed that depression was caused by a “chemical imbalance” of low levels of serotonin and which could be treated with “chemically balancing” antidepressants such as Prozac, Zoloft, Paxil, and other selective serotonin reuptake inhibitors (SSRIs). [To source this one only has to read a patient information leaflet that accompanies the various SSRI's on the market today]

The Myth

"No biological etiology has been proven for any psychiatric disorder in spite of decades of research. Don't accept the myth that we can make an 'accurate diagnosis.' Neither should you believe that your problems are due solely to a 'chemical imbalance.'" - Edward Drummond, M.D. Associate Medical Director, Seacoast Mental Health Center, Portsmouth, NH

"After a half-century of research, the chemical-imbalance hypothesis as promulgated by the drug companies that manufacture SSRIs and other antidepressants is not only with clear and consistent support, but has been disproved by experimental evidence."  ― Irving Kirsch, The Emperor's New Drugs: Exploding the Antidepressant Myth

"There is no chemical imbalance to begin with, but when treating mental illness with drugs, we create a chemical imbalance, an artificial condition that the brain tries to counteract." - Dr. David Healy, Psychiatrist, psychopharmacologist, scientist, and author

"The actual truth about a chemical imbalance is that it’s an actual lie. Nobody has yet measured, demonstrated, or created a test to show that somebody has a chemical imbalance in their brain. Period." - Thomas Stephen Szasz - Psychiatrist and academic, a Fellow of the American Psychiatric Association, a member of the American Psychoanalytic Association, a professor of psychiatry at the State University of New York and starting in 1990, he was professor emeritus of psychiatry at the State University of New York Upstate Medical University in Syracuse.

People, despite these findings, still continue to take antidepressants because they are told by doctors and psychiatrists, and the pharmaceutical companies that their depression is caused by a chemical imbalance. Moreover, healthcare professionals, including family doctors and  adult and pediatric psychiatrists continue to prescribe antidepressants to millions of people the world over.


The Apathy

When the teachings of the Bible were proven to have flaws we saw little interest. People world-wide shrugged their shoulders and said "So what, we will never fully understand God's way, after all, he is mysterious. I still believe in his work."

Can you imagine the headlines 2,000 years ago?

How would the people of those times reacted?

Well, I guess with apathy, the same apathy that is shown by millions of people when they read the same thing about the mythical marketing of antidepressants and depression. "So what, we will never fully understand how the brain works, after all, it's complex. I still believe antidepressants work."

I've often wondered why churches, whatever their domination, refuse to speak out about the harm antidepressants cause - One church does, for that they are ridiculed and labelled as 'nutters' or 'brain washers" - This being the Church of Scientology.

For the record, I'm neither a Scientologist or attached to any other religious denomination. Point I'm making is one party speaks out and the other parties ridicule.

Coroner's Inquests

AntiDepAware is a website created by a friend of mine. 'Brian' collates newspaper archives of coroner inquests, he has amassed quite a database.

What Brian tries to do is create awareness where the coroner fails.

Here's just one recent example of Brian's...

15-year-old schoolboy George Werb died near his home in Colyton, South Devon, on Friday June 28 2013, when he was struck by a train.

George’s father Justin told the inquest held this week that George first started to become withdrawn about 18 months before his death. He began to have delusions that he was suffering from ailments and diseases, but had to wait 10 months until his first appointment with a Child and Adolescent Mental Health Services (CAMHS) team member. He was diagnosed as suffering from psychosis involving persistent delusion disorder with depression.

George was initially prescribed the anti-psychotic drug Olanzapine, but Justin explained that they noticed a “massive change” in their son from the point he started taking the medication. George became extremely distressed, and the medication was discontinued.

George’s parents were subsequently advised that he needed hospitalisation to ensure his safety and for ongoing assessment and treatment. The closest hospital with availability was 220 km away at Huntercombe Hospital in Berkshire, where George was prescribed the antidepressant Fluoxetine (Prozac), after which he became suicidal and withdrew from the drug.

George’s parents were dissatisfied with the hospital and with George’s treatment there, and removed him after three weeks.

After returning home for a short period, George was sectioned and, in the month before his death, was admitted to the Priory, Southampton, 140 km from home.

Here he was treated by psychiatrist Dr Carlos Hoyos. He was once more prescribed Olanzapine and, at first, placed on one-to-one observations. Over the course of the following weeks his observations were reduced and his medication regime increased.

George’s mother Joanne told the inquest that, days before he died, she read a note by George expressing his worry about the effect that his medications were having on him. She said that she told Dr Hoyos about the note and of George’s desperation to come off Olanzapine.

She said: “We did tell him that George was suicidal. But he did not want to discuss it. He was just adamant George stay on the dosage he was on and start with the Fluoxetine. We felt he had not listened to what we had tried to say to him.”

George, at the tender age of just 15, walked in front of a train after being released from the Priory.

Antidepressants and Suicide... and Apathy

The issue of suicidality on SSRIs became one of public concern with reports in 1990 that Prozac could lead to suicidality in patients.

Fourteen years later, warning labels were put on antidepressants.

We still have those same shoulders shrugging today then those of fourteen years ago. We still have doctors and psychiatrists prescribing these medications, ignoring the findings.

Ironically, Psychiatry does not see religion as a mental disorder. If a Christian, or any other religious follower, told a psychiatrist that he believed the earth was just over 6,000 years old then his treating psychiatrist could not diagnose him/her with any delusional mental disorder.. yet a 15 year-old child, who had a slight case of hypochondria, is prescribed mind altering drugs that are known to induce suicide.

And we, the general public still shrug our shoulders.


Something is radically wrong with the human belief system.

Bob Fiddaman.

Listen to AC/DC's 'Play Ball' in Full [Updated]

Bob Fiddaman

AC/DC - In Rock We Trust, it's Rock or Bust!

I was fortunate to be part of an AC/DC video shoot yesterday. The shoot, for a future release from AC/DC's new album, "Rock Or Bust", was filmed at Black Island Studios in London, Middlesex to be precise.

An email confirming the shoot was sent out on Friday, it was all pretty vague, meet at location in London, hand over ticket and be given a coach ticket to be driven to studio.

It was thought that the 500 or so lucky punters would be part of another song off the album, namely "Play Ball". The video for this song, however, was recorded at Black Island the day before with no fan participation.

After queuing in the rain for what seemed like an eternity, I, and the other fans who had turned up, some from Canada and Argentina, were given coach tickets. A 40 minute drive to the studios with the accompanying "Confidentiality Agreements" to sign saw us arrive and shepherded into a waiting room. When here we all got to hear the track that we would be part of that day. "Rock or Bust", the title track off the new album was played, the acoustics of the room not really giving it justice to breathe.

This was all about to change...

We were each directed to positions in the studio next door, the set was a mini-mock-up of a stadium (see pic)

Pic courtesy of acdcbrasil.net

With phones and camera's being confiscated there wouldn't be much chance of recording the audio or taking photos during the shoot, I'm unsure how the above photo was leaked?

The band were introduced and each member walked down to the small round stage. Unfortunately, AC/DC drummer, Phil Rudd, had been called away at the last minute, his place being filled by Bob Richards (Shogun, Adrian Smith Band The Wild Family, Man)

A huge cheer greeted them all then subsided as Brian took the mic to address the fans. He spoke of Malcolm and the overwhelming wave of support he had received from fans across the world, he then introduced Malcolm's permanent replacement Stevie Young, nephew of both Angus and Malcolm Young.

Myself and some old friends I had met from Sweden were directed to one of the upper tiers and, along with others, were anticipating hearing "Rock Or Bust" and watching the band perform.

The 500 strong crowd needed no direction. The thing is, being an AC/DC fan you pretty much know what you are going to get.

"Rock Or Bust" is a foot-stomping, fist-punching assault to the ears, it's anthemic and was made in mind for the fan. If you are after lyrics that are life-changing, you'll be disappointed. AC/DC don't do lyrics that make you ponder, they write lyrics that make you want to grab your imaginary guitar and lose yourself in simplicity.

Although the song was not performed live (studio version piped in) you could hear that familiar sound, a little bit of Angus before the drums kicking in along with the bass then vocals that may surprise many.

AC/DC's vocalist Brian Johnson, at 67, still knows how to belt out a good tune, most people his age revert to Sinatra or Elvis but Johnson gives it full pelt in this short rock number that will have you throwing fists in the air for many years to come.

AC/DC are back and although the line-up may be different you really can't tell. Stevie Young is an accomplished rhythm guitarist, he's been playing the circuits for many years and he fits perfectly, he's that t-shirt that hides the beer belly, the one that we all feel comfortable wearing.

The shoot was surprisingly short, 4 or 5 takes and we were all done, a far cry from a previous video shoot I was privileged of being part of (Are You Ready)

The masses departed the studio, Rock or Bust still ringing in their ears.

We now await the album release (late Nov, early Dec) and, of course, await to see the release of both videos, Play Ball and Rock or Bust.

Yesterday may be the last time we get to see AC/DC in a video shoot, the release of the album will see them embark on a world tour, it may be their last given that it's been 6 years since their last album (Black Ice) - if we add on 6 years from their tour next year then any future releases will come around 2021, I really can't see AC/DC hitting the road in 2021. I hope I'm wrong as they have been a part of my life since I first heard them back in the late 70's.

If you have never seen AC/DC in concert you have missed out on something, they should be on everyone's bucket list.

AC/DC are legends, it really is as simple as that.

**Special mention to Cameron Sinclair without whom none of this would have been possible.

Get well soon brother.

Bob Fiddaman.

Chantix Dangers

The following is a message from Kim Witczak, a drug safety advocate who is testifying in front of the FDA soon on behalf of users of Chantix who have experienced severe side effects - the FDA are considering removing the black box warning that comes with Chantix.

For those that don't know Chantix is a smoking cessation drug and has a dark history with regard to suicidal and homicidal acts. It's maker, Pfizer, have made many settlements out of court. Chantix is also known as Champix, it's generic name being varenicline.

In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of Chantix after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately.

The FAA took this action one week after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.

Chantix was the subject of a freedom of information request I made back in April 2010. I had learned that the Federal Aviation Administration [FAA] had changed their policy regarding pilots being allowed to operate aircraft whilst under the influence of SSRi-type medication. The full 58 page document sent to me can be read here.

Here's a message from Kim.

You can contact her with your story via the email address at the end of her message.

--

Have you or anyone you know taken Chantix to quit smoking?

The psychiatric side effects of Chantix are moving back to center stage. Later this month the FDA will be holding hearings to decide whether or not to remove or reduce the black box warnings on Chantix.

Chantix came under fire after reports of hostility, suicide, suicide attempts and other psychiatric disturbances such as aggression and nightmares. In 2009 FDA required a "black box" warning (most serious of warnings) on the drug, to alert patients and doctors to the risk of psychiatric side effects.

Now, they are saying after further review the data from recent studies found little or no evidence of psychiatric problems. What gives?

Last year Pfizer settled the majority of its 2,700 lawsuits against it for $275M. Chantix had global sales of $648 million last year. That was down about 26 percent from the drug's peak sales of $883 million in 2007.

How you can help???

In preparation for my testimony at the FDA hearing, I will be representing the voice of people who have experienced psychiatric side effects from taking this drug. If you have a personal story and are willing to share it, please let me know. We need real life experiences vs just what Pfizer shares.

As you many of you know, I have been working on drug safety issues since my husband took his own life after being given antidepressant Zoloft for insomnia in 2003. (At the time there were no warnings on these drugs.) There are many parallels between the narratives surrounding antidepressants and Chantix. There are many, including myself, who believe that this is the first step in undoing the black box warnings for antidepressants.

Warnings are there for a reason. It gives information about a drug's potential risks and what to look for if you or loved one are taking it. You never know if you or your loved one may be the small % of risk. But that small % could be your 100%.

If you have a Chantix story, please share.

Email - Info@woodymatters.com


Bob Fiddaman.