The Drugs Industry and The Regulators : Balancing “Benefits and Risks”…


When talking about prescription drugs , regulators and pharmaceutical companies regularly tout the well worn mantra of “benefits” and “risks”, but what exactly do they mean? , who decides on a drug’s benefit and who decides on how “risky” it is?…

In the case of Seroxat, the “risks” clearly outweigh the “benefits”. Seroxat is supposed to help depression (and a myriad of emotional responses, from anxiety to panic attacks) yet in its prescription leaflet, it states that anxiety, panic attacks, suicidal ideation and mood changes can be attributed to the pill. What benefit is that to a depressed patient? …

Not much…

If we take into account, the fact (the Royal College of Psychiatry UK state on their website) that “depression will go away after about 8 months for most people”, then that narrows the supposed benefits of SSRI (Seroxat) treatment to an even smaller figure. Psychiatric drugs, their side effects, who decides on their benefit, and who should be prescribed them, are all very dubious and subjective assumptions indeed…

http://www.dailymail.co.uk/health/article-2061267/Schoolgirl-left-waking-coma-sleeps-23-hours-day-severe-reaction-cervical-cancer-jab.html#ixzz1dhtBq7J1

GSK’s HPV Cervical Vaccine has been touted as a preventative jab for Cervical Cancer. Yet, A spokeswoman for NHS Cumbria said: ‘In the UK, about 3,000 women are diagnosed with cervical cancer every year and about 1,000 die from it.

So basically, 3,000 Women in the UK are diagnosed with Cervical Cancer each year, out of an estimated population of 30,000,0000 . That’s a figure of one in 10, 0000 chances of catching Cervical Cancer for UK Women during their lifetime. But the stat from dying from it is a third of that, therefore, there is around 1 in a 30,0000 chance of a UK woman dying from Cervical cancer in her lifetime.

It can take from 15 to 20 years for Cervical Cancer to develop in Women who have the virus, therefore the success (or failure) of mass vaccination programs will not be known for another generation at least…

But, according to the Daily Mail UK …

Of the four million vaccinations carried out over the programme’s first two years, there were 4,445 reported side effects.

1,669 reported ‘injection-site reactions’ for example a sore arm.

1,013 reported allergic reactions, most were rashes.

There were 3,591 ‘other recognised reactions’ including 631 cases of nausea and 629 headaches.

There were four cases of Guillan-Barre Syndrome, which can lead to paralysis. Although the Medicines and Healthcare products Regulatory Agency notes: ‘There is no evidence that the vaccine has increased the frequency of GBS above that expected to occur naturally in the population’.

None of the deaths or serious health problems which have followed immunisation has been directly linked to the vaccine – but it has been known to trigger undetected health problems.

Some critics also believe that the HPV injection can give teenagers a false sense of security, encouraging them to be more sexually active because they no longer have to fear cervical cancer

These Young girls were guinea pigs for GSK…

Who knows what other adverse side effects GSK’s vaccine will manifest? ..

Do the benefits really outweigh the risks?…

Of Course, GSK (and their regulator Buddies)… Caring as always about public health, released this statement :

‘Any suspected adverse reaction related to vaccination can be very distressing and we take these reports very seriously.
‘The UK medicines safety agency regularly reviews all reported suspected adverse events and has concluded that no new or serious risks have been identified during use of Cervarix in the UK, and that the balance of benefits and risks remains positive.

‘With GSK’s record of seriously damaging drugs, such as Seroxat and Avandia, can we really trust them to vaccinate anyone against anything?

I don’t think we can…

http://www.dailymail.co.uk/health/article-2061267/Schoolgirl-left-waking-coma-sleeps-23-hours-day-severe-reaction-cervical-cancer-jab.html

Girl, 13, left in ‘waking coma’ and sleeps for 23 hours a day after severe reaction to cervical cancer jabs
Lucy Hinks is unable to walk or talk after having injections at school

Parents warn others to check on potential side effects of Cervarix vaccine

By LAUREN PAXMAN
Last updated at 6:19 PM on 14th November 2011

Bad reaction: Lucy Hinks, 13, began to experience extreme exhaustion soon after having the cervical cancer vaccine alongside classmates
A schoolgirl has been left in a ‘waking coma’, too exhausted to open her eyes or speak, after having a cervical cancer vaccine.
Last October and again a month later, Lucy Hinks joined her classmates at school in Wigton in Cumbria to have the HPV jab Cervarix as part of a country-wide programme.
By Christmas, she had visited the doctor several times with flu-like symptoms, tiredness and joint pain.
After the third injection of the vaccine, in May this year, Lucy began to experience extreme exhaustion.
Her health has now deteriorated to such an extent that for the past seven weeks she has slept for up to 23 hours day.
Lucy is also unable to walk or even talk to her devastated family.
Today, her mother Pauline and father Steve, who works for Pirelli, reveal the stress their family is enduring and their fears that it could be years before she recovers.
They now care for Lucy – who has lost nearly three stone – around the clock and describe their lives as a ‘living nightmare’.
The couple, from Port Carlisle, Cumbria, are urging parents to find out about the potential side effects of the vaccine, Cervarix.
Their warning comes as thousands of year eight pupils prepare to receive the vaccine in schools.
Mrs Hinks said: ‘I would not wish what we’ve been through on anyone.
‘I’ve not seen the whites of Lucy’s eyes for weeks and nobody can tell us when it will turn.
‘I would urge parents to get all the facts, gather as much information as you can. Decide for yourself if it’s right for your child.’

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She added: ‘I could put up with the constant sleep. I believe her body needs it.
‘But it’s the fact that to me she’s in a waking coma, with no treatment.
‘At first we didn’t pay any major attention to it. We were only aware there was something seriously wrong this July.’
Lucy, a bright scholar at Nelson Tomlinson School with a gift for maths, had her third and final instalment of the vaccine in May.
Soon afterwards, she started displaying signs of exhaustion.
HUMAN PAPILLOMAVIRUS (HPV)

Almost all cases of cervical cancer start off as an HPV infection.
There are more than 30 types of HPV. The virus is typically transmitted through sexual contact.
80 per cent of women will contract a form of HPV by the time they reach 50, most forms are harmless.
Two of the types, numbers 16 and 18, are responsible for 70 per cent of cervical cancer cases.
These two strains are treatable with HPV vaccines which are 98 per cent effective.
The other types of HPV are not preventable with the injections, which is why women must still have regular smear tests.
Only 5-10 per cent of women infected with the virus face the risk of the disease developing into cervical cancer.
This process usually takes 15–20 years.
‘Then she got up one weekend,’ said Mrs Hinks. ‘She shouted for me, she was too exhausted to stand.’
Initially, Lucy’s GP found her spleen and liver were enlarged. Then, after the teenager collapsed in the doctor’s waiting room, she was taken to Carlisle’s Cumberland Infirmary.
She was submitted to a barrage of tests over the weeks to come, including those for glandular fever and a brain tumour. But these failed to find any cause.
Later in the summer, Lucy was again admitted to hospital. This time she was unable to walk at all.
Mr Hinks said: ‘She had been able to limp from the settee to the toilet herself.
‘But suddenly she couldn’t take a single step. She lost her balance, her arms and legs were failing.
‘We got a letter from the consultant at the hospital. It says it’s quite possible that this might turn out to be a reaction to the HPV vaccine.’
Lucy’s parents now attend her every need and one of them is always nearby.
Mrs Hinks, who gets up to her daughter through the night, said: ‘At one stage I thought she was going to die in her sleep.’
Lucy’s daily routine begins with a small breakfast of a scone and dried fruit about 9.30am.
‘I stroke her face, talk to her,’ said her mother. ‘Then I pull her up onto pillows. I bring a bowl of water and wash her. She feeds herself her breakfast.
‘Slowly, and she never opens her eyes.’
Recently, the family installed a stairlift to take Lucy from her bed to the living room sofa.
‘I bring her downstairs because she’s part of the family,’ said Mrs Hinks. ‘I want her down here and hope that subconsciously she can hear something of what’s going on.’
They have rigged up an electric bell which Lucy presses when she needs pain relief.
‘She can whisper five words,’ said Mr Hinks, who uses a microphone to help make out Lucy’s barely audible syllables.
‘She says “hurting, toilet, tablet, water” and, most of all, “mum”.’
Mr and Mrs Hinks spoon feed their daughter her lunch and dinner. Meals must consist of soft food, because chewing takes precious energy.
The couple said doctors are now 95 per cent sure Lucy’s diagnosis of ME/Chronic Fatigue Syndrome (CFS) is correct.
She has a nurse who visits weekly and is under the care of a consultant paediatrician at the West Cumberland Hospital in Whitehaven – both of whom the Hinks praise highly.
Mrs Hinks has revisited the decision to allow Lucy to have the vaccine many times.
‘I have regrets,’ she said. ‘But it’s no good having them because you can’t change what we’ve got. Hindsight is a marvellous thing.’

Constant care: Lucy’s parents now attend her every need and one of them is always nearby. She is pictured with her sister Emily, 12, (left) who was recently offered the injection

TODAY’S POLL

Would you let your daughter have the HPV injection?

According to Lucy’s parents, there is no treatment plan as such for CFS/ME and they take each day as it comes, using instinct to determine her needs.
She has now lost nearly three stone in weight and her parents are terrified she may need to be fed through a tube in the future.
The couple are exhausted and heartbroken, though remain pragmatic.
Mrs Hinks is frank: ‘We’re not launching a campaign. Our only concern is to keep our daughter alive.’
But the pair say they were never given information about any potential side-effects of the vaccine.
At the time Mrs Hinks signed the consent form for Lucy to have the treatment, she raised concerns because Lucy had suffered a reaction to the MMR vaccine in infancy.
‘I was told not to worry,’ she said.
Though neither has any criticisms of the local vaccination programme, Mr and Mrs Hinks are now urging parents to make sure they have as much information as possible before making a decision.
‘Talk to people about it,’ said Mrs Hinks. ‘You decide, not the Government, whether it’s right for your child.
CERVICAL CANCER JAB CONTROVERSY
The NHS initiated its UK HPV immunisation programme in September 2008.
The HPV jab is available on the NHS to those aged between 12 and 13 years old. Many are immunised at school.
Vaccines are delivered in three shots over six months. They do not have any therapeutic effect on existing HPV infections or cervical lesions which is why girls are vaccinated before they become sexually active.
The vaccine cuts the risk of cervical cancer by about 70 per cent
Of the four million vaccinations carried out over the programme’s first two years, there were 4,445 reported side effects.
1,669 reported ‘injection-site reactions’ for example a sore arm.
1,013 reported allergic reactions, most were rashes.
There were 3,591 ‘other recognised reactions’ including 631 cases of nausea and 629 headaches.
There were four cases of Guillan-Barre Syndrome, which can lead to paralysis. Although the Medicines and Healthcare products Regulatory Agency notes: ‘There is no evidence that the vaccine has increased the frequency of GBS above that expected to occur naturally in the population’.
None of the deaths or serious health problems which have followed immunisation has been directly linked to the vaccine – but it has been known to trigger undetected health problems.
Some critics also believe that the HPV injection can give teenagers a false sense of security, encouraging them to be more sexually active because they no longer have to fear cervical cancer.

‘I accept that out of all the girls in Cumbria in Lucy’s year, she might be the only one. But for one child to lose the quality of life she had is one too many.’
Lucy’s paediatrician has warned it could be years before she recovers.
‘Right now education is irrelevant,’ said Mrs Hinks. ‘Lucy is not in a situation where she can stay in contact with her friends at all. I worry this will have an impact on her down the line.
‘People ask ‘how do you cope?’ Well, you just have to.’
Mr Hinks copes by trawling the internet for cures. He has found case studies of other girls who are believed to have suffered similar reactions to the vaccine.
The couple were also recently asked to have their other daughter, 12-year-old Emily, vaccinated with Cervarix.
They refused and wrote to the health authority stating their fears.

Coping mechanism: Steve Hinks trawls the internet for cures. He has found case studies of other girls who are believed to have suffered similar reactions to the vaccine
Last month, Mr Hinks met Cumbria’s associate director of public health, Dr Nigel Calvert, and the county’s immunisation coordinator, Jane Morphet, to express his concerns.
Ms Morphet has since written to the national director of immunisation, David Salisbury, to ask if there is ‘any new evidence of any possible link between the vaccine and CFS/ME’.
A ‘yellow card’ – a report made to the Medicines and Healthcare Products Regulatory Agency over suspected side effects to drugs or vaccines – has been lodged. And Cervarix manufacturers, GlaxoSmithKline, are aware of the family’s concerns.
The Hinks’ are now considering taking legal advice. Pauline says: ‘How does she cope after our day? Down the line you never know what you might need to do.’
Despite the circumstances, the Hinks’ still believe they are lucky.
Mr Hinks is a health and safety environment manager for Pirelli in Carlisle and his wife manages a sports and social club associated with the plant.
They say the firm has been fantastic and is to help them get a second opinion on Lucy’s condition from doctors abroad.
Mr Hinks says: ‘We both have jobs, we had to write out the cheque for the stairlift there and then. At least we can do that.’
Each day, the family pray Lucy will begin to respond more and will try anything to raise a tiny smile.
‘I’ve told her that if she can talk to us, she can have a puppy,’ said Mrs Hinks.
‘Even if she just gave us a glimmer, that would be something.’
A spokeswoman at GlaxoSmithKline said: ‘Any suspected adverse reaction related to vaccination can be very distressing and we take these reports very seriously.
‘The UK medicines safety agency regularly reviews all reported suspected adverse events and has concluded that no new or serious risks have been identified during use of Cervarix in the UK, and that the balance of benefits and risks remains positive.’
Cumbria’s health authority says the cervical cancer jab used to immunise 60,000 girls in the county so far has a ‘strong safety record’.
‘She can whisper five words. She says “hurting”, “toilet”, “tablet”, “water” and, most of all, “Mum”‘
The dangers of the disease were highlighted by the death of reality TV star Jade Goody from cervical cancer.
A spokeswoman for NHS Cumbria said: ‘In the UK, about 3,000 women are diagnosed with cervical cancer every year and about 1,000 die from it.
‘The HPV vaccine is designed to help protect young women from developing the human papilloma virus, one of the causes of cervical cancer.
‘The vaccine has been rigorously tested and a million doses have now been given in the UK.’
Lucy is not the first to have suffered devastating health effects apparently linked to the injection.
Rachel Attridge, then 17, was unable to move, speak or eat for four months, after she was struck down 18 months ago with Guillain-Barre Syndrome – a rare disease where the body’s immune system attacks the nervous system by mistake.
Her doctors told her they were ‘99.9 per cent sure’, the illness had been triggered by the cervical cancer jab.
In one of the most high-profile cases linked to the injection, though, Natalie Morton’s death – one hour after being given the jab – was judged to be nothing to do with the immunisation.
The 14-year-old died from an undiagnosed heart tumour

Read more: http://www.dailymail.co.uk/health/article-2061267/Schoolgirl-left-waking-coma-sleeps-23-hours-day-severe-reaction-cervical-cancer-jab.html#ixzz1dhxM2Lv8

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