Alli (GSK’s Weight Loss Pill): Another GSK Product With ‘Hidden Harms’? …


A weight-loss pill taken by millions of patients in the last two decades has been propped up by problematic clinical studies that “systematically understated” the drug’s potential harms, according to a new analysis. Danish researchers who reviewed data summaries and published journal articles found that seven drug trials funded by the drug maker Roche in the 1990s downplayed the frequency of apparent side effects like diarrhea or incontinence.

The drug, known to scientists as orlistat, and marketed in the US as Alli, has generated hundreds of millions in sales but has slumped in recent years in part because of a reputation for unpleasant gastrointestinal side effects.

The analysis shines light on “something that clinicians often are suspicious of: that the adverse event reporting in clinical trials doesn’t give the whole picture,” said Dr. Raj Padwal, a clinical pharmacologist and internist at the University of Alberta, who was not involved in the analysis.

The new research, published Tuesday in PLOS Medicine, didn’t examine the data reports that were submitted to the Food and Drug Administration when orlistat was approved, first in 1999 as a prescription drug sold by Roche as Xenical or later as a low-dose, over-the-counter pill sold by GlaxoSmithKline as Alli. (The FDA did, however, review the data from the trials in question.)

Those trials, conducted in the 1990s by researchers at academic or medical centers, resulted in journal articles. To evaluate the thoroughness of these articles, the Danish researchers compared them to data summaries submitted to European regulators, which were obtained by filing Freedom of Information Act requests. They found that the publications disclosed just a fraction — between 14 and 33 percent — of patients’ so-called “adverse events” as compared to the data summaries.

For example, two of the publications left out apparent side effects that occurred in fewer than 5 percent of trial participants; another counted multiple reports from the same patient as just one adverse event.

Another two articles, which are listed currently on Alli’s website as evidence of the drug’s safety and effectiveness, were also problematic. One of them only reported apparent side effects deemed “common”; the other omitted reports of apparent side effects that weren’t at least twice as common among trial participants taking the drug as those taking a placebo.

All of the studies in question still stand in the scientific literature.

Anja von Treskow, a spokeswoman for Roche, said the reporting on the trials “was done according to the standards of the time” and that the company “continuously update[s] our methods” to comply with changing standards.

Joanmarie Goddard, a spokeswoman for Alli’s marketer, GlaxoSmithKline, said the company “take[s] adverse event reporting for our products very seriously and routinely monitor[s] safety information in conjunction with health care professionals and regulatory agencies worldwide.”

The rise and fall of a weight-loss pill

In the first year after Roche brought Xenical to market in the US, the drug brought in $600 million worldwide. Over the course of the 2000s, the drug was prescribed 11 million times in the US, according to an analysis of data from the consumer group Public Citizen. When GSK launched the drug over-the-counter as Alli in 2007, it blew through the gates, selling $155 million in its first weeks on the market.

The drug, which is meant to be paired with diet and exercise, works by preventing the body from absorbing fat. But excreting lots of fat makes the stool oily, leading to gastrointestinal side effects for many patients.

Even at the drug’s peak, warning signs were apparent. US prescriptions of Xenical declined every year. A 2007 study of nearly 17,000 patients found that just 6 percent of participants were still taking Xenical after one year; after two years, it was down to 2 percent.

That’s an indication that “the balance between efficacy and harms is not very beneficial,” said Dr. Jeppe Schroll, lead author of the new analysis and a researcher at the Nordic Cochrane Centre in Copenhagen.

Then in 2010, the FDA added a warning to both Xenical and Alli cautioning about “rare reports” of liver damage; a 2012 study found such alarming toxicity effects that the researcher immediately reported his findings to the FDA.

Roche no longer markets Xenical in the US, though generic versions of the prescription drug are still available. GSK no longer breaks out Alli sales in its financial reports, and wouldn’t comment on current sales figures for the drug. A pack of 120 Alli pills sells online for $56.

In spite of orlistat’s struggles, drug makers aren’t giving up on the pill. A Canadian drug company, M Pharmaceutical, is working on a reformulated alternative that will steer clear of the existing drug’s “socially unacceptable ‘underwear issues.’”

The problem of hidden harms

It’s hard to say how common the harms reporting discrepancies uncovered in the new orlistat analysis are.

The Danish researchers noted that space restrictions in journals may have played a role in what was disclosed, and that data reporting standards that have since been developed might make their findings less applicable to newer drugs.

Dr. Rohan Khera, a cardiology fellow at UT Southwestern Medical Center who has studied the effectiveness of different weight-loss drugs, called the new analysis “a good start in figuring out that there is a need to study this in further detail.”

Dr. Sidney Wolfe, a consumer advocate with Public Citizen who has unsuccessfully petitioned US regulators to take orlistat off the market, believes the stakes are high. “If you’re a doctor and rely on medical journals, you may be misled. Doctors don’t have the time to go reading the actual raw data,” he said.

Eliza Carthy and The Wayward Band – Cobblers Hornpipe


Ireland has great folk music, and the tradition is strong, but English folk music is often just as powerful… Particularly when played by the mighty Eliza Carthy of the Carthy folk dynasty…. fantastic passion and emotion in these tracks…

 

 

On Hounslow Heath as I rode o’er
I spied a lawyer riding before.
“Kind sir are you afraid,

Of Turpin, that mischievous blade?”

O rare Turpin hero,
O rare Turpin O

Said Turpin, “He’d ne’er find me here
I hid my money in my boot.”
The lawyer says, “There’s none can find,
I hid my gold in my cape behind.”

O rare Turpin hero,
O rare Turpin O

As they were riding past the mill
Turpin commands him to stand still;
Says, “Your cloak I must cut off,
My mare she needs a saddle cloth.”

O rare Turpin hero,
O rare Turpin O

As Turpin rode in search of prey
He spied a man on taxway;
And boldly then he bid him stand,
“Your gold,” he said, “I do demand.”

O rare Turpin hero,
O rare Turpin O

Oh Turpin then without remorse,
He knocked him quite from off his horse;
And left him on the ground to sprawl
While he rode off with his gold and all.

O rare Turpin hero,
O rare Turpin O

Well Turpin is condemned to die,
To hang upon yon gallows high;
Whose legacy is a strong rope,
For the shooting of a dung-hill cock.

O rare Turpin hero,
O rare Turpin O

Irish government fights claims by children with narcolepsy after Pandemrix swine flu vaccine


http://www.belfasttelegraph.co.uk/news/republic-of-ireland/irish-government-fights-claims-by-children-with-narcolepsy-after-pandemrix-swine-flu-vaccine-34770780.html

 

Irish government fights claims by children with narcolepsy after Pandemrix swine flu vaccine

 

Irish government fights claims by children with narcolepsy after Pandemrix swine flu vaccine

By Eilish O’Regan

Published 03/06/2016

The Irish government is fighting compensation claims by children who developed an incurable sleeping disorder after getting the Pandemrix swine flu vaccine.

This is despite a Government-commissioned report saying the Pandemrix jab left susceptible children at 14 times greater risk of developing the condition.

It said other “unspecified factors” may also have played a role.

The first legal stage of the cases will come before the High Court next week when an order for discovery of documents from the Department of Health and the vaccine manufacturer GlaxoSmithcline (GSK) will be sought.

Solicitor Michael Boylan of Augustus Cullen Law, who represents 60 of the children, revealed yesterday that he is shocked the State is denying liability and fighting the families.

It is denying it owes a duty of care to the children who received the vaccine.

“They are denying everything and putting us on proof of everything. Denying a duty of care is very radical.”

Mr Boylan said the Irish expert group found a 14-fold increase in the incidence of narcolepsy among children vaccinated, compared to those who did not get the jab.

The untested vaccine was rushed out during global panic over the swine flu pandemic in the winter of 2009 and 2010.

Read more

Swine flu jab linked to narcolepsy

Irish doctors must return flu vaccine over narcolepsy fears  

The pandemic turned out to be much milder than feared but parents were strongly urged by senior medical officers in the Department of Health and public health experts to have children, who were a risk group for the virus, vaccinated.

However, some 80 children who received the vaccine went on to develop the sleeping disorder narcolepsy.

The rare disorder causes people to feel drowsy or to suffer spontaneous ‘sleep attacks’. They can sometimes experience loss of muscle power and fall. This can be triggered by stimulus like laughter.

All of the young people, many of whom are now teenagers or young adults, are on medication to stay awake during the day or sleep at night.

Mr Boylan said the children allege negligence by the State and GSK in the circumstances where they were administered an untested vaccine and/or that the vaccine was a defective product.

Parents were not made aware of the fact that it was untested, he added.

At the time the vaccine was issued, GSK got the then government to grant the drugs giant indemnity from any potential compensation claims.

Mr Boylan said: “Other countries like Switzerland, America, Poland and Australia would not give a licence to the vaccine.

“They were afraid it was not fully tested.”

He said boosters were included in the vaccine, which increase the body’s immune response to the jab.

“It is not clear why the manufacturing process for the vaccine in Quebec in Canada, where no cases of narcolepsy followed, was different to that of the drugs plant in Dresden.”

Children in several other countries have been compensated; some through no-fault vaccine redress schemes.

In the Netherlands, some children have got payouts of nearly €1m and the sums demanded here are likely to be in seven figures, he added.

“If you look at the public health leaflets at the time they state ‘it stops with you.’

“People were made to feel they had a civic duty to get the vaccine to stop the plague.”

He said the health effects are devastating for many of the children.

Most also have cataplexy, in which they “collapse like a puppet” and have suffered accidents like falls down stairs or crashes through glass panes in showers.

Mairead Hilliard, whose son Alex (11) developed narcolepsy after the jab, said yesterday the condition has left the young people on life-long medication and at risk of never meeting their full potential.

The compensation is needed because of the debilitating effect it has on their ability to live a normal life, she said.

They are all growing up now and some are students who find they are fighting the illness all the time, and there is no cure for it, she added.

Irish Independent

Background

Pandemrix, a vaccine used in response to the swine flu pandemic that began in 2009, increased children’s risk of narcolepsy – a chronic disorder which causes excessive daytime sleepiness, research suggests. For every 55,000 doses delivered around one child developed the condition, said health experts.

The research, published in the British Medical Journal, examined 75 children aged between four and 18 who were diagnosed with narcolepsy from January 2008 and who attended sleep centres across England. Researchers from the Health Protection Agency (HPA) and Papworth and Addenbrooke’s hospitals in Cambridge found that 11 of these had received the vaccine before their symptoms began.

After adjusting for clinical conditions, the authors associated the vaccination with a 14-fold increased risk of narcolepsy. In absolute numbers, this means that one in 52,000 to 57,500 doses are associated with narcolepsy, said the authors. Since 2011, the use of the vaccine in people under the age of 20 across Europe has been restricted following reports of increased cases of the sleep disorder – which is characterised by periods of extreme drowsiness, sudden naps, and paralysis attacks.

Are GSK Responsible For This Woman’s Death?…


http://www.mirror.co.uk/news/uk-news/nursery-nurse-killed-herself-after-8610711

Nursery nurse ‘killed herself after developing sleep disorder after she received swine flu vaccine’

Katie Clack, 23, became depressed after developing narcolepsy in 2009 and jumped to her death from a car park five years later

PA Katie Clack as a coroner has concluded it is "most likely" that the nursery nurse developed the sleep disorder narcolepsy as a result of receiving a swine flu vaccination
Katie Clack fell from a car park after developing the sleep disorder narcolepsy

A nursery nurse killed herself after becoming depressed over a sleep disorder which “most likely” developed after she received a swine flu vaccination, an inquest heard.

Katie Clack, 23, became depressed after developing narcolepsy in 2009.

She jumped to her death from the top of a multi-storey car park in Peterborough in September 2014.

Her narcolepsy had led to her sleeping for up to 19 hours per day on occasions and her mental health worsened.

An inquest in Stamford heard that the Peterborough woman did not want the vaccine but was required to take it for her job.

Recording a narrative conclusion, Paul Cooper, acting senior coroner for South Lincolnshire, said studies showed there were “significantly raised odds of narcolepsy after (being given the) Pandemrix” vaccine in those aged 18 and above.

Hoax caller warned if she swears at anyone she could face a jail sentence

“On the available evidence on the association between vaccination with Pandemrix and onset of narcolepsy it seems most likely that receipt of this vaccine in December 2009 caused Miss Clack’s narcolepsy,” said Mr Cooper.

He added that narcolepsy triggers depression, though he noted the case of Ms Clack was “complex and very rare”.

A statement issued on behalf of Ms Clack’s family said: “Katie was an energetic young woman who had just discovered her passion working with children.

“Narcolepsy turned her life into a terrible daily struggle and drastically reduced her quality of life.

“We cannot believe she would have decided to take her own life had the balance of her mind not been disturbed.”

Ms Colvin added: “The Clack family has waited a long time for this inquest.

“It is important that the coroner has recognised the casual link between the vaccine and narcolepsy and the devastating impact this had on Katie’s short life.”

Earlier this year a boy who developed the sleeping disorder caused by the swine flu vaccine was awarded £120,000 in damages.

Josh Hadfield, 10, from Frome in Somerset, developed narcolepsy after receiving the Pandemrix vaccine six years ago.

In 2013, lawyers launched a class action on behalf of 38 Britons – including 19 children – who developed narcolepsy after having the vaccine.

Scientists from the former Health Protection Agency (HPA) said there was evidence of a link between the Pandemrix jab – manufactured by GlaxoSmithKline(GSK) – and narcolepsy in children.

HPA figures suggested one in 55,000 children vaccinated – about 20 in the UK – are thought to have developed narcolepsy.

Josh was awarded the money after an appeal against the Government, which had initially refused to pay as he was not “severely disabled” enough.

Speaking at the time, a spokesman for GlaxoSmithKline said: “We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.”

It was also supporting investigations into reported cases.

Across Europe, about 31 million people are thought to have received the Pandemrix jab.

Narcolepsy is a rare but serious neurological disorder that affects about 31,000 people in Britain.

The condition can cause massive disruption to sleep and daily life.

A Department of Health spokesman said: “Katie’s death was tragic and we offer our sympathies to her family.

“Pandemrix vaccine was used to prevent serious illness and deaths during the swine flu pandemic in 2009/10.

“At the time, the possible association with narcolepsy was not known.”

This Is How Glaxo Treats Animals…


http://www.timesherald.com/business/20160810/glaxo-smith-kline-laboratory-king-of-prussia-cited-after-death-of-animal

 

Glaxo Smith Kline laboratory, King of Prussia, cited after death of animal

Negligence at a Glaxo Smith Kline laboratory – the second largest employer here – has led to a primate strangling to death in violation of federal laws, according to a national research watchdog group.

A recently obtained government inspection report reveals the U.S. Department of Agriculture, which oversees research laboratories, cited Glaxo Smith Kline for violating federal laws, said SAEN (Stop Animal Exploitation NOW!), which monitors the nation’s research facilities for violation of law and abuse of animals.

A USDA inspection report dated June 14 specifically cited Glaxo Smith Kline for violating the primary enclosure requirements of the Animal Welfare Act – a primate was able to open the squeeze lock mechanism and move the back panel of the cage forward, which resulted in the primate getting caught in the space created and choking to death.

In its official complaint SAEN filed with the USDA, SAEN is insisting on an additional citation and a federal fine which could be as high as $10,000 per infraction.


“Glaxo Smith Kline’s primate enclosure did not satisfy the safety requirements set by federal law, and a primate suffered and died as a result. Because an animal was subject to prolonged suffering and death, this lab deserves of a severe penalty,” said Stacey Ellison, SAEN research analyst.

Pfizer, GSK Accused of Price Gouging of Vaccinations for Refugees in Greece


http://www.triplepundit.com/2016/08/pfizer-gsk-accused-price-gouging-vaccinations-refugees-greece/

Pfizer, GSK Accused of Price Gouging of Vaccinations for Refugees in Greece

Syrian refugees, refugees, vaccines, immunizations, Doctors without Borders, Greece, Leon Kaye, human rights
MSF is protesting the high prices it has to pay for vaccines.

GlaxoSmithKline (GSK) and Pfizer are amongst the pharmaceutical companies that insist they are doing what they can to help the world cope with the global refugee crisis. But according to the humanitarian aid group, Doctors Without Borders/Médecins Sans Frontières (MSF), these companies’ obstinacy in lowering their price for critical vaccines at refugee camps in Greece is putting children at risk.

MSF put volunteer doctors to work in Greece when the humanitarian crisis in that country exploded last year, due largely to the influx of Syrian refugees fleeing their country’s ongoing civil war. In five Greek islands, on the country’s border with Macedonia and in Athens, MSF provides a bevy of services, including mental health consultations, immediate care for victims of torture and the delivery of basic healthcare.

But the key focus for MSF is immunizations. The lack of healthcare access in Afghanistan, Iraq and Syria made it nearly impossible for many families to vaccinate their children. The crowded and often unsanitary conditions at these refugee camps put them at risk for rapid disease outbreaks. Add the trauma and exhaustion suffered by many of these refugees, and the chances of life-threatening illnesses sweeping through these settlements becomes even higher. To that end, MSF said it has vaccinated at least 5,000 children, from the ages of 6 months to 15 years, across these camps since May.

The problem, however, is that while most pharmaceutical companies have long agreed to sell their vaccines and medicines to developing countries at a highly discounted rate, the same policy has not applied to middle- and higher-income countries trying to cope with this ongoing crisis.

https://www.instagram.com/p/BH2LtCCD9wR/embed/captioned/?v=7

Most critical, according to MSF, is for pneumonia vaccines (PCV) to be sold at a rate at or near the lowest available rates sold on the global market. Governments of poorer nations can purchase such vaccines for as low as $3.10 a dose. But because such pricing is not available in Greece, MSF claims each dose costs 60 euros (US$68) at local pharmacies. MSF says it cannot purchase the vaccines through Gavi, the international organization that works with pharmaceutical firms to price vaccines at a far more affordable rate.

MSF pressed the issue with an online petition, signed by over 400,000 people, that asked pharmaceutical companies to lower the price of their pneumonia vaccines. The NGO said its representatives personally delivered copies of that petition to Pfizer and GSK at their American and Europen offices.

So far, however, neither company is budging. GSK, for example, already declared that it would not lower its price any further. GSK claims that its PCV, Synflorix, is already priced at $9.15 per child ($3.05 a dose, as a child must be inoculated three times in order for the vaccine to be effective). MSF requested the price drop globally to $5 for the full course of doses, but GSK said that would mean it would have to sell and distribute that vaccine at a loss. The company says it has already entered into a three-year agreement with MSF to supply Synflorix for use in refugee camps.

While the world has turned its attention elsewhere since the refugee crisis dominated the newswires last fall, this human rights crisis is far from going away. The Christian Science Monitor, in fact, reported that while far fewer refugees are attempting to cross from Turkey into Greece, a spike in the number of North Africans attempting to cross the Mediterranean is underway. Big Pharma, NGOs such as MSF, governments and the United Nations must arrive at consensus on countless challenges the refugee crisis presents the world. And preventing communicable diseases from spreading, and treating children who had no say in leaving their homes, has got to be at or near the top of this list.

Image credit: MSF/Edwin Torres

Supermodel Cara Delevigne Doesn’t Agree With Anti-depressants…


Interesting article about super-model Cara Delevigne…

I wonder what ‘meds’ she was prescribed?…


http://www.tv3.ie/xpose/article/entertainment-news/212493/Cara-Delevingne-doesnt-agree-with-antidepressants

Cara Delevingne ‘doesn’t agree’ with anti-depressants

4th Aug 16 | Entertainment News

Cara Delevingne stopped taking anti-depressants because she didn’t want to become dependent on medication.

Suicide Squad European Premiere

The model-turned-actress has been candid about her battle with depression, and how it left her feeling so low that she even contemplated suicide around the age of 16.

She was placed on a strong cocktail of medication but decided to come off the tablets when she was 18 because she never wanted to become reliant on them.

“I hate meds,” she told Britain’s Esquire magazine. “I don’t agree with them. It’s so easy to abuse them.”

She added that she immediately felt the difference once she came off her medication because her feelings returned and she had sex for the first time.

“That week (I stopped taking them), I lost my virginity, I got into fights, I cried, I laughed,” she admitted. “It was the best thing in the world to feel things again. And I get depressed still but I would rather learn to figure it out myself rather be dependent on meds, ever.”

During the interview, she spoke about having a mental breakdown as a teenager. Dealing with her hormones and the pressure of achieving good school grades sent her into a downwards spiral so severe that she even considered taking her own life.

“I couldn’t deal with it anymore. I realised how lucky and privileged I was, but all I wanted to do was die,” she explained. “I felt so guilty because of that and hated myself because of that, and then it’s a cycle. I didn’t want to exist anymore. I wanted for each molecule of my body to disintegrate. I wanted to die.”

During that time, Cara, 23, dropped out of boarding school and pursued a career in modelling, following in the footsteps of her older sister Poppy.

© WENN Newsdesk 2016

GSK’s Avandia And The RICO Act (Racketeer Influenced and Corrupt Organizations)


pharmafia

An interesting GSK scandal brewing away at the minute is the Avandia scandal and the RICO Act 1970. The RICO Act was originally brought about to prosecute organized crime syndicates like the Mafia in the US therefore it is interesting (and wholly appropriate) that GSK should be prosecuted under it too. They are, after all- Global Serial Killers- and a Pharmafia- type- organization who have proven time and time again, over decades, to be nothing but utterly corrupt and fraudulent.

See RICO Act Avandia Suit here


http://www.biopharmadive.com/news/high-court-rules-glaxosmithkline-must-face-rico-suits-over-avandia/420476/

High court rules GlaxoSmithKline must face RICO suits over Avandia

Dive Brief:

  • The Supreme Court ruled Monday that GlaxoSmithKline must face lawsuits brought by three union health plans that said they overpaid for the diabetes pill Avandia.

  • The lawsuits claims GSK concealed the cardiovascular risks of Avandia to boost sales
  • The three union health funds are pursuing a claim under the RICO act, claiming GSK was engaged in an illegal conspiracy.

Dive Insight:

The suits, filed by three union health funds between 2007 and 2010, claim the plans paid more for prescriptions than they would if they knew of the risks. Avandia was hit with an FDA label warning in 2007, and with new restrictions in 2010, as reports surfaced of the cardiovascular risks.

The FDA lifted all its safety measures late last year, but the drug had fallen from $3 billion in annual sales to less than $200 million. The FDA subsequently took a fresh look at Avandia data and voted in 2013 to remove many of the restrictions it had placed on the drugs, saying the data did not show an increased cardioviscular risk over standard diabetes treatments.

Recommended Reading

Business Intelligence: U.S. top court rejects Glaxo bid to throw out racketeering lawsuits
Stat: Supreme Court says Glaxo must face racketeering suits over a diabetes pill