Back in September 2009, started the buzz about a new drug that is more effective than Prozac in treating depression.

Background
At just £1-a-day, the drug agomelatine – also known as Valdoxan – was found to help 77.7% of people with severe depression. In comparison Prozac was found to help 68.8%.
Previous research has shown that, in the first week of treatment, agomelatine works in twice as many people compared to the antidepressant venlafaxine – Efexor.
There are also fewer side-effects from agomelatine, which can include weight gain, sexual problems and difficulty sleeping.
The latest study was carried out on 515 patients with an average age of 42, who were followed for eight weeks.

Prozac can cause nausea
The authors concluded: “This study demonstrates the superior efficacy of agomelatine over fluoxetine – Prozac – in treating severe depression, with a good tolerability profile, confirming that agomelatine offers a good alternative for the treatment of depression including the severe forms.”
Lead researcher Professor Tony Hale, head of division of psychiatry at the University of Kent, added: “These results, showing better efficacy over Prozac, one of the most commonly prescribed antidepressants in the UK, add to the growing wealth of evidence supporting agomelatine as a new and important alternative for the treatment of depression.
“Despite the wide range of currently available antidepressants, there are still unmet needs in the management of depression.”

Positive Buzz
There are a lot of people buzzing about the drug about, i caught the following comments:

“I was part of a clinical trial with agomelatine last year for GAD (General Anxiety disorders) and was on agomelatine for 4 months. At the beginning I was extremely skeptical, which I think could be attributed to being a neuroscience PhD student. I’ve done preclinical research in the area of antidepressants for years and my knowledge of the field has led me to be very questioning towards such medications. But the effects of agomelatine really forced me to change my point of view. Before this trial I had never taken anything for my GAD and I found that I started to feel different after about 2 weeks. The experience was absolutely life changing and I’ve never been able to replicate it with other medications since.

The thing that made the biggest impression was the quality of my sleep. My sleep was incredible. I can’t even fully describe it. I hadn’t even realized that my sleep was so bad until it changed. I would wake up feeling absolutely refreshed and energized. I would be very alert and awake all day and right up until bedtime. My sleep was very regular and very efficient. I found I needed much less sleep and felt better than ever.

My GAD symptoms also pretty much disappeared with absolutely NO side effects. And I appreciate this so much more in hindsight because I seem to be VERY sensitive to side effects of SSRI’s and I’ve been struggling in vain since I stopped agomelatine.

When I came off the drug I wasn’t aware of it (after 4 months of medications we started a period of double-blind placebo), but it was obvious within the first week. I didn’t experience any actual withdrawal symptoms, I just went back to the way I had been before. My sleep was terrible and all my GAD symptoms came back over the course of a few weeks.”

How does it work?
Valdoxan (agomelatine) is the first melatonergic antidepressant. The drug combines antidepressant efficacy with an extremely favourable side-effect profile and has
the additional benefit of sleep regulation in depressive patients.
So you have tow effects there :
First the drug does promote serotonin reuptake as usual SSRI drugs do, but you don’t get the traditional side effects.
Second the drug relieves from sleep disruption without affecting daytime vigilance.
The combination of these two effects is seen as a key advantage for an antidepressant.

What is Valdoxan expected to be used for?
Valdoxan is expected to be used in adult patients to treat major depressive disorder. In major depressive disorder, patients have disturbances of mood that interfere with their everyday life. They may suffer from deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight. The key symptoms are depressed mood and loss/diminished interest or pleasure. Patients often suffer relapses (when the disease comes back after it has been treated).

Is it available ?
Agomelatine was launched in the UK by manufacturer Servier in June at a pack price of £38.53 for a packet of 28 25mg tablets – compared to the £1.02 net cost of a 30-cap pack of 20mg fluoxetine.

Data on Valdoxan here:
http://emc.medicines.org.uk/medicine/21830/SPC/Valdoxan/
http://www.paxilprogress.org/forums/showthread.php?t=14390
http://en.wikipedia.org/wiki/Agomelatine

At the end of September 2009, the European drugs regulator gave the go-ahead for one of the UK’s swine flu vaccines. An expert committee agreed that Pandemrix, made by GlaxoSmithKline(GSK), can be used in adults and children over six months old and pregnant women. The UK has bought 60 million doses of the vaccine.

Also, the UK government has already signed a contract for an as yet unapproved vaccine, Celvapan, produced by Baxter. It means the UK has provision for up to 132 million doses – enough for every person in the country.

Finally a third vaccine made by Novartis, Focetria, has also been recommended for licensing by the European Medicines Agency – but this is not planned to be used in the UK.

The decision removes one of the last obstacles to getting the immunization program under way although licensing still needs to be formalized.

Final marketing authorization for the vaccines still needs to be signed off by the European Commission and is expected “as soon as possible”.
The EMEA said they were working with Baxter on some ongoing issues about their vaccine but hoped to be able to resolve those next week.

Approval of the vaccine
The vaccines have undergone an accelerated approval process as “mock-ups” of the vaccine had already been developed in preparation for a pandemic and tested in 6,000 people.
Manufacturers have worked quickly to add the swine flu H1N1 strain to the mock versions.
Early trial data had suggested good immune responses with just one dose of the vaccines.
However, the EMEA is recommending two doses are given three weeks apart for both vaccines, but may revisit that decision as more clinical trials are carried out.

A background of rising cases of swine flu
The number of new cases of swine flu in England has almost doubled from the middle of September 2009.
In Scotland, the new weekly figures showed a slight increase from 6,180 to 7,034.
Across the UK there have been 82 deaths.
Although the figures are rising, they are as yet far short of the 100,000 cases a week seen in July.
Officials are still predicting a second wave of swine flu as winter approaches.
Worldwide some 3,917 people have died from swine flu infections since the H1N1 virus was uncovered in April, World Health Organization figures show.

When will the vaccine be distributed to the population ?
The UK Government plans to start vaccination in October 2009, subject to vaccine being licensed and manufacturers’ delivery schedules.

Why Two vaccines?
The UK has agreed contracts for swine flu vaccine with GSK and Baxter. Having two contracts increases the number of doses available. Also because the Baxter vaccine is not made in eggs it can be used in people with an egg allergy
There are other differences between the vaccines -for example the GSK one contains an adjuvant. It minimizes the risk of problems should one vaccine run into trouble during production or licensing.

Who should be vaccinated against swine flu?
Eventually, everyone, except for people who have the same allergies — primarily, allergy to eggs — that make annual flu shots dangerous for them. But for now, the first vaccine batches are reserved for those most at-risk: health care and emergency workers; pregnant women; people caring for infants younger than 6 months old; people 6 months to 24 years old; and anyone younger than 65 who has a weakened immune system or such medical conditions as asthma, diabetes or morbid obesity. As more vaccines are made, healthy adults ages 25 and up should be vaccinated, too.

How can I be sure it’s safe?
It’s very safe, the H1N1 vaccine is made in the same way as the regular winter flu vaccine that is used by nearly 100 million Americans a year with very few, minor side effects. There’s no biological reason the H1N1 vaccine should react any differently, and no red flags have appeared in studies of several thousand people.

However what you should look for is GBS..
Some Neurologists are concerned that an increase in a brain disorder called Guillain-Barre Syndrome (GBS) could be triggered by the vaccine. GBS attacks the lining of the nerves, causing paralysis and inability to breathe, and can be fatal.

The debacle of the US swine flu Vaccine in 1976
There are concerns that with the new vaccine, there could be a repeat of what became known as the ‘1976 debacle’ in the US, where a swine flu vaccine killed 25 people – more than the virus itself.
A mass vaccination was given the go-ahead by President Gerald Ford because scientists believed that the swine flu strain was similar to the one responsible for the 1918-19 pandemic, which killed half a million Americans and 20million people worldwide.
The swine flu vaccine being offered to children had not been tested on infants
Within days, symptoms of GBS were reported among those who had been immunized and 25 people died from respiratory failure after severe paralysis. One in 80,000 people came down with the condition. In contrast, just one person died of swine flu.
More than 40million Americans had received the vaccine by the time the program was stopped after ten weeks. The US Government paid out millions of dollars in compensation to those affected.
The swine flu virus in the new vaccine is a slightly different strain from the 1976 virus, but the possibility of an increased incidence of GBS remains a concern.

UK regulators have set up a special portal on the website for reporting any problems with swine flu medicines and vaccines when they begin to be used.

Today Q&A about the news that a 14 year old girl died soon after receiving the Cervarix vaccine in the UK.

My view

It’s always sad when someone dies.

I have no objection to the safety of vaccinations. It is a fact that there are risks, but they are remote, especially when compared to the diseases they prevent.  We do not know yet what caused the accident but this is the first death in England.

Any doctor will tell you that death caused by vaccine will be very rare and that since 750 women die from cervical cancer in England every year the benefits outweigh the costs.

One issue does remain, the vaccine has not been proved to work beyond the 5 year period and the vaccine is marketed as working for 5+ years, so there may be a need for vaccinate again all those young girls (see death stats here).

I have to say there are a lot of critics out there. Some will question the success rate of the vaccine, some will question the link between the HPV virus and having cervix cancer, some will attack the marketing techniques, some will say that regardless of the vaccine a yearly review will still be needed, some regard the vaccination program as an experiment. So many more…

Apart from all these views which are well worth listening to,  I am of the view that this vaccine program is worth being undertaken. I just hope a better vaccine will in time be developed  that has lesser side effects.

What happened?

All we know at this stage is that a 14-year-old girl tragically died shortly after being given the vaccine. We do not know her past medical history, and a post-mortem has yet to be held to ascertain the cause of death.

What do we know about the vaccine?

Cervarix vaccine prevents infection with the two commonest types of HPV involved in cervical cancer. HPV stands for Human Papillomavirus.

Cervarix is given in three doses during a six-month period to trigger immune responses that help protect against two strains of HPV responsible for most cervical cancer cases.

The vaccine is approved for females ages 9 to 26. The vaccine has not been tested beyond 5 years so it is not known how long the immunity from the vaccine will last beyond that.

Even with the cervical screening program, in England, each year, there are:

• 21,617 cases of advanced precancerous disease.

• 2,221 cases of invasive cancer of the cervix.

• 899 deaths from cancer of the cervix.

The vaccine will probably prevent around 70% of these. It has been used in this country for just over a year, and more than a million doses have been given. Worldwide, many more doses have been administered with a good safety record.

Here are links to some stats and infor from the NHS

Is the vaccine safe?

The vaccine is safe, there will always be events of bad reactions and some mild to serious side effects.  Since the vaccine was introduced (it is now licensed in over 90 countries), its safety has been monitored very carefully. In spite of millions of doses being given, we haven’t heard of other deaths.

Now i don’t want to appear biased but the side effects do exist.  In the UK, Cervarix has been used for a year now, there have been over 2000 adverse reactions and over 4000 suspected adverse reactions. About 10 of these are so serious that their families are suing Glaxo Smith Kline, the manufacturer of the vaccine. Read here on page 2.

My conclusion is that overall, rarely a person does have a life-threatening allergic reaction after a vaccine and things have not changed with this one.

Could there be a problem with a particular batch of vaccine?

Until we know more, this is impossible to say. However, as a precaution, the batch from which this young girl was immunised (AHPVA043BB).

Should we go on using the vaccine?

The worldwide track record of this vaccine is such that it is most unlikely there is any problem with the vaccine in general.

The UK Government introduced a systematic program of vaccination in April 2008 to protects girls from the sexually transmitted human papillomavirus which causes 70 per cent of cervical tumours.
When the Government introduced the Cervarix vaccination programme last year, some campaigners dubbed it a “promiscuity jab”. The vaccine was developped by Galxosmithkline.

In total the drug safety watchdog Medicines and Health care products Regulatory Agency (MHRA) has recorded so far about more than 2,000 suspected reactions but these were overall mild, with dozens of girls recording rashes, pain in the arm, and allergies.

A support group says it has received dozens of calls from parents who believe their daughters have been damaged by the vaccine.
The parents of one teenage girl given the jab last autumn believe it was to blame for repeated seizures which have left her with brain damage and psychosis.

The report prepared by the MHRA earlier this month also discloses cases in which teens have suffered convulsions, eye rolling, muscle spasms, seizures and hyperventilation soon after being given the jab.

The analysis by the MHRA, drawn up this month, found 2,107 patients had reported some kind of suspected adverse reaction to Cervarix. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total.

Jackie Fletcher, founder of Jabs, a support group for families whose children have fallen ill after immunisation, said she had taken dozens of calls from parents who believed their daughters had been damaged by the cervical cancer vaccine.

She said: “We have spoken to parents whose daughters have had seizures, paralysis, blurred vision, severe headaches and the loss of feeling in parts of their body.

“Doctors will try to convince parents that these problems are in their child’s mind, or have nothing to do with the vaccines, but we don’t think there is sufficient evidence to show Cervarix is safe.”
Medical safety experts insist the benefits of the vaccine outweigh the risks.

A spokesman for GlaxoSmithKline, which makes Cervarix, said the drug had to undergo rigorous testing, with over 70,000 doses used in trials before a licence was granted.