GSK Given Warning Over Baby and Infant Medicine

It's only being reported in one news media outlet and I have wrote to them to ask for confirmation but, it seems like, GSK have been given a warning by the UAE ministry regarding the dosage instructions for Panadol.

The National UAE write the following...

The Ministry of Health has issued a warning to pharmaceuticals company GlaxoSmithKline telling it to modify the dosage instructions on the packaging of Panadol Baby and Infant Suspension. 

The ministry said that it discovered a mistake in the prescribed dosage that could lead to overdose, which could cause liver poisoning in children. 

Paediatricians, pharmacists and medical practitioners have been told to calculate the adequate dose based on the child’s age and weight and not rely on the dosage instructions shown on the outer package of the medicine until they are duly modified and approved by the drug department at the ministry.

It's a surprisingly short article given that parents may be administering potentially lethal doses of Panadol to their infants and children without actually realizing it!

The Ministry of Health UAE make no mention of the above on their website so I flicked GlaxoSmithKline an email to ask for confirmation of the alleged warning they had received.

Dear GSK,

I am writing to you in regard of a recent article that appeared in The National UAE that made reference to your product Panadol.

The article suggests that GSK were issued a warning by the UAE Ministry because, and I quote,  "they discovered a mistake in the prescribed dosage that could lead to overdose which could cause liver poisoning in children."

 Can you confirm if, in the interests of transparency, this article is correct please.

Sincerely,
--
Bob Fiddaman

Given that GSK normally make you jump through hoops before they answer a straight forward question, I've decided to run with this article and also highlight where Panadol has been in the news before.

In 2013 the Essential Baby online magazine wrote an article regarding a safety scare over GSK's Panadol. At the time, GSK acted promptly. They had learned that Children's Panadol Baby Drops syringes were faulty and could lead to parents giving their children more medication than is required.

Here's a photo of the faulty syringe compared to the correct syringe.

I'm sure you'll agree that's quite a faulty product. GSK's Children's Panadol Baby Drops  is for babies and children aged between one month and two years of age.

At the time GlaxoSmithKline medical director Andrew Yeates said even if babies had been given the incorrect doses of medication using the syringes, there was a "low risk" to their health.

Hmm, thanks for the reassurance!

One year later and the Essential Baby online magazine were once again reporting on GSK's Panadol.

This time they learned that GSK's Children's Panadol 1-5 Years Colour free Suspension also had a faulty syringe. Here's what they wrote...

The confusion with the Panadol syringe stems from the fact that to measure a correct dose, the widest part of the plunger needs to be in line with the desired dosage marking on the syringe.

"This differs from most syringes which measure to the tip of the plunger where the liquid finishes," the advisory reads. 

"With the Children's Panadol syringe, the liquid continues past the tip of the plunger and therefore needs be measured to where the widest sides of the plunger meet the barrel of the syringe."

If the syringe is used to measure in the incorrect way, an extra 1.26mls will be given with each dose of Children's Panadol.

Excessive doses of paracetamol can be harmful to the liver and the harmful effects can be fatal if not detected and treated.

So, if the story currently being covered by The National UAE is, in fact, correct then one has to ask, why can't GSK get their dosages right, more importantly, isn't it about time that they did? The target population for these products, infants and babies, really can't do it for themselves!

When we also take into account that GSK have been accused of making payments of $1,500 each to two doctors to promote Panadol in Syria then alarm bells must surely be calling for Andrew Witty to get his house in order.

This company, it could be argued, could damage your child's health.

Bob Fiddaman.

**If I get a response from either GSK or The National UAE then I shall amend this blog post accordingly.**

Irish Babies and GSK - Why the delay?

Photo courtesy of Irish Central - Religious orders allowed over 2,000 Irish children to be used in medical experiments

News that almost 800 bodies of babies had been found in a septic tank in Ireland surfaced last week. Now known as the 'Irish Baby Graves Scandal', 796 babies are thought to have been interred alongside what was called "The Home", run by Bon Secours nuns in Tuam. The proprietors took in "fallen women" and "illegitimate children" between the 1920's and 1960's.

The story has been linked to a vaccine clinical trial from the 1930's. The International Business Times writes...

Over 2,000 babies and young children at a number of Irish orphanages linked to the mass baby graves scandal were injected with a vaccine for diphtheria in the 1930s, it has been revealed. The children were used as guinea pigs on behalf of drugs giant Burroughs Wellcome. No evidence of consent has been discovered and there are no records of how many children became ill or died as a result.

Burroughs Wellcome, later subsumed into drugs giant GlaxoSmithKline (GSK)

Many are sickened by this news and both GSK and the Catholic church have come under fire.

It's a story, however, that isn't as fresh as what the mainstream press are letting on.

Four years ago, in 2010, the Irish Independent reported that legal action was being planned against GlaxoSmithKline and the Sacred Heart Order, which allowed the tests at the Bessborough Mother and Baby Home in Cork.

Campaigner and abuse survivor John Barrett alleged that was used in four different experiments when he was aged 12 and 13 at the Lota home.


He said: "All of the boys of my age were taken off and given tests, X-rays and general examinations.

"Lists were made of those deemed to be 'healthy' and we would sometimes be lined up in one of the dormitories and given massive injections."

At the time of these revelations the then Irish Health Minister, Mary Harney, was called on to instruct her officials to make available all relevant information regarding the ongoing vaccine trials.

The call, according to the Irish Times, came as a result of Mari Steed, 50, breaking her silence into how she was subjected to a controversial vaccine trial as a baby without her mother's consent.

She said she the trial were carried out on her between December 1960 and October 1961, when she was between nine and 18 months old.

Ms Steed, who in 2010 was living in the US, and three others, were preparing to take legal action in US courts against GlaxoSmithKline.

Whatever came of that legal action?

Moreover, did  the then Irish Health Minister, Mary Harney secure all relevant information regarding the ongoing vaccine trials?

Do GlaxoSmithKline still hold records that belonged to Burroughs Wellcome, if so, why haven't these documents been released to investigators?

Why, four years on are we still asking for these documents and why, four years on, are GlaxoSmithKline being quoted as saying,  “The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.

“We would need further details to investigate what actually took place, but the practices outlined certainly don’t reflect how modern clinical trials are carried out. We conduct our trials to the same high scientific and ethical standards, no matter where in the world they are run.”

Was the investigation four years ago brushed under the carpet, was an out of court settlement made to those who intended to file a lawsuit in the US?

Who, exactly, is at fault here, is it the Irish government, the Catholic church or GlaxoSmithKline?

Not much is known about these clinical trials, the whole scandal seems to have been put to bed for the last four years...only to resurface again with the 'Irish Baby Graves Scandal'.

A good source of information can be found on Paddy Doyle's website, The God Squad. Paddy has been investigating the whole sordid affair for sometime now.

In the meantime we wait for Glaxo to get the "further details to investigate what actually took place".

Don't hold your breath folks.


Related

Pressure mounts for GSK [inquiry into trials of vaccines]

Bob Fiddaman.

Glaxo Fined £60,000 For Killing 14 Babies

Throw a cat in a bin and get massive media coverage and public outrage. Kill 14 babies and our British press don't even give it a small column. We've lost our morals folks. Glaxo are a British company and their wrong-doings should be reported by the British press. With James Murdoch on the board at GSK and with Andrew Witty cupping the balls of the UK government with the threat of moving his business elsewhere, it's left, once again, to bloggers to report on this abhorrent misuse of human life.

What price a human life?

Well Judge Marcelo Aguinsky has fined GlaxoSmithKline 400,000 Argentinian Pesos [about £60,000] for its part in the 2007/08 vaccine trials conducted in Argentina where 14 children died. The charges, writes the Herald, included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

The Buenos Aires Herald reports:

The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan.

By my reckoning that's just over £4,000 per child.


"GSK Argentina set a protocol at the hospital, and recruited several doctors working there," Pediatrician Ana Marchese told Continental AM radio in an interview. Adding that:

“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries."

GlaxoSmithKline Argentina are appealing the decision. Medical Director Rosana Felice said in a statement, "None of the deaths are related to the vaccines", and added, "Likewise, Glaxo doesn’t pay any kind of bribes in order to lead any clinical studies here in Argentina or at any other location around the globe."

Phew! Thank goodness for that, for one minute I thought they had actually been rumbled.


The GlaxoSmithKline corporate motto is, "We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer."


Based on the findings in the above enquiry I'd suggest that GlaxoSmithKline look up the words 'Inspiring', 'Improve' and 'Quality'.



Full shameful story in the Buenos Aires Herald

Heads up: Pharmalot

Back story: Is GlaxoSmithKline Behaving Badly in Argentina?


On January 1st Glaxo CEO Andrew Witty was knighted.

Nice to see our monarchy getting its priorities in order.

Glaxo's Augmentin for Paediatric Patients Recalled

The Hong Kong Department of Health announced yesterday that they had ordered GlaxoSmithKline to recall an antibiotic manufactured in France for paediatric patients.

Augmentin powder for syrup, used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin, was found to have traces of a plasticiser, Diisodecyl phthalate (DIDP) in the 156mg/5ml bottles.

Diisodecyl phthalate (DIDP) is a commonly used plasticizer used in the production of plastic and plastic coating to increase flexibility. It is a mixture of compounds derived from the esterification of phthalic acid and isomeric decyl alcohols.

The coating on furnishings, cookware, pharmaceutical pills, food wrappers and many other products may have DIDP or other phthalates in them. There has been recent concern in the USA and European Union for their toxicity and bioaccumulative quality. [1]

7th Space Interactive writes:

Referring to the detection of plasticiser in Augmentin in Taiwan in particular, the spokesman explained, "Augmentin is an antibiotic for the treatment of bacterial infections. In Hong Kong, there are two Augmentin products containing flavouring agents, both of which are registered under GSK by the Pharmacy and Poisons Board, namely Augmentin powder for syrup 156mg/5ml manufactured in France, and Augmentin powder for syrup 457mg/5ml manufactured in the UK. Both are for use in children.

Samples were submitted earlier on to the Government Laboratory (GL) for plasticiser analysis."

The spokesman went on to reveal that, "On testing, the GL found DIDP in the French-made Augmentin powder for syrup 156mg/5ml at a level of 18ppm. This is two times Europe's specific migration limit for DIDP for food contact materials. Plasticisers were not otherwise detected in the other samples tested."

Well, whaddya know - Glaxo and children's medicine in the news [again]

The Hong Kong Standard also reports on Glaxo's product recall, they write:

A British pharmaceutical firm faces possible prosecution in Hong Kong after tests showed a pediatric syrup manufactured in its French factory contained twice the allowable limit for a plasticizer.

...The Augmentin powder for syrup 457/5ml manufactured in Britain did not have any trace of DIDP. Both contained flavoring agents, suspected to be the main source of contamination.

The department has already notified the Drug Regulatory Authority in France.

"The source of DIDP is yet to be investigated by the manufacturers," a spokeswoman said.

About 400 children treated at Hospital Authority clinics and hospitals have been prescribed the drug and still have it on hand.

GlaxoSmithKline's corporate motto is that it helps people to...

DO MORE
FEEL BETTER
LIVE LONGER
[1] http://en.wikipedia.org/wiki/Diisodecyl_phthalate