Posts tagged pharma

GSK fined after over vaccine trials; 14 babies reported dead

GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies.

Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.

The charges included experimenting with human beings as well 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 seven babies died in Santiago del Estero; five in Mendoza; and twoo in San Juan.

Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies wee being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”

“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.”

Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.

Likewise, Marchese, explained the modus operandi: “Once a picked patient arrived, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These kind of practices are not legal and occurred without any type of state control, plus they don’t comply with minimum ethical requirements.”

Marchese also remembered that “laboratory trials on human beings are not legalized in Argentina.”

Furthermore, the pediatrician explained that “it is also known that in various particular cases, the doctors who had conducted the trials did not answer the calls made by the worried parents after witnessing their babies’ reactions to the vaccines.”

According to Marchese, “there already exist very good vaccines for the same diseases, but we all know how laboratories work, they only care for their own business.”

To end, Doctor Marchese aimed to Santiago del Estero Governor, Gerardo Zamora, who “never ever came out to stage to comment on the case, and same happened with national deputies and senators that didn’t even bother into discussing a hot topic that was echoed worldwide. I’m also ashamed of the scientific community that also kept its mouth shut.”

Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero, said that “A lot of people wanted to leave the protocol but they weren’t allowed; they forced them to continue under the threat that if they leave they won’t receive any other vaccine.”

During 2008, the vaccine trial was still ongoing despite the reports issued by FESPROSA, and those in charge of the study told reporters that the procedures were being carried out in a lawful manner.

On the contrary, the ruling states that the laboratory as well the involved doctors broke all legal requirements for conducting clinical tests on babies.

Surprisingly, during same year pediatrician Enrique Smith, one of the lead investigators told reporters: “Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria.”

In Santiago del Estero, one of the country’s poorest provinces, the trials were authorized when Enrique’s brother, Juan Carlos Smith, was provincial health minister.

According to Fesprosa, “the laboratory paid $8,000 pesos for each child included in the study, but none (of that money) remained in the province that lends the public facilities and the health personnel for the private research.”

Meanwhile, a press communiqué was released by the ANMAT indicating that the irregularities detected during the COMPASS vaccine trial programme were related to “failures in the process of obtaining informed consent for participation, hence violating patients’ rights, and the inclusion of patients that did not fully meet the required clinical conditions to be submitted to the programme.”

Furthermore, the release states that “We [ANMAT] expressly remark that none of the deaths mentioned in the news stories were related to the vaccines given as part of the COMPASS programme, since all the involved patients had received blind placebo, which is a simile of the vaccine but without any active substance. The vaccine is safe.”

GlaxoSmithKline is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world’s third-largest pharmaceutical company measured by revenues after Johnson & Johnson and Pfizer.

Ironically, if one visits GlaxoSmithKline Argentina web site it welcomes the reader with a company disclosure that says: “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.”

According to www.GSK.com site, Glaxo was originally a baby food manufacturer processing local milk into a baby food by the same name, and founded in Bunnythorpe, New Zealand in 1904. The product was sold in the 1930s under the slogan “Glaxo builds bonny babies”.

GlaxoSmithKline Argentina’s massive 28,333 square-metre manufacturing plant is located in Northern Greater Buenos Aires town of San Fernando.

(Source: buenosairesherald.com)

Health experts say a growing shortage of a number of drugs in the US will start to affect patients in Australia.

Late last year the Food and Drug Administration in the US released a concerning report into drug shortages, showing nearly 200 medicines were in short supply - three times more than in 2006.

The shortage is mainly in cancer, anaesthetic and anti-infective drugs like penicillin.

This rise has already started delaying, even denying treatments for US patients with critical medical conditions.

Doctors and patient groups in Australia are now warning patients about how these shortages might affect them.

Ovarian Cancer Australia chief executive Annabelle Davis says her group has told hundreds of its members, who rely on a drug called Doxil, to start preparing.

“Doxil, which is more commonly known in Australia as Caelyx, is used to treat women with advanced ovarian cancer,” she said.

“Many of these women are prescribed the drug because they’re resistant to other more common treatments; one of the last options for them.

“So the fact that it’s not available at this time will be certainly of some concern and anguish to them.”

The pharmaceutical industry is increasingly globalised, which is why these shortages will affect Australians.

The industry says it needs financial incentives to keep up with growing demand in drugs.

Australian Medical Association president Dr Steve Hambleton says shortages happen mostly when a manufacturer malfunctions.

“Things like fire in manufacturing plants, the Japanese earthquake caused some problems, even the Icelandic volcano caused transportation issues and it can go right back to errors in labelling or other things,” he said.

“The problem is that when you’re manufacturing for the market, if the drug has been around for a long time there may be only one or two manufacturers and if there’s a problem in both plants at the same time, then you have a potential issue.”

Global industry

There are 2,500 medicines on the Therapeutic Goods Administration (TGA) list and the drug industry says so far they have managed the shortages well.

Medicines Australia chief executive Dr Brendan Shaw concedes it would be better to boost the capacity of local suppliers, however in the current market he says this may not be possible.

“The medicines industry these days is a global industry and it’s because we have a global industry that we have access to so many different medicines,” he said.

“There are some issues that we need to address long-term about proper reimbursement or the incentives for supplying medicines to market and indeed manufacturing them in Australia.

“And I think it’s important also that governments, when setting prices for medicines, also need to take into account making sure the viability of supplying that medicine and making sure that medicines can be supplied in Australia and indeed manufactured in Australia.”

Dr Shaw says this might come at a cost; the price of drugs will have to be much higher.

“It is important that when pricing medicines on the market that industry viability is considered; that is you’ve got to make sure there’s enough incentive there for companies to supply the market,” he said.

“It’s one thing in the short-term to try and cut costs by driving prices down, but it’s also important to remember to have incentives for companies to supply that medicine.

“If the incentives are too low then it’ll be commercially difficult for those companies to supply those medicines.”

For its part, the TGA has released a statement saying it works closely with the industry to ensure continuity of supply and to identify alternative sources of medicine.

(Source: abc.net.au)

For almost two years, an infant school pupil has found himself losing muscle control and falling asleep at a moment’s notice due to a rare sleeping illness.

Six-year-old Josh Hadfield, from Frome in Somerset, had shown no symptoms of narcolepsy prior to February 2010, and it took another year for doctors to diagnose the condition.

Josh’s mother, Caroline, fears it could be linked to a swine flu vaccine called Pandemrix which he received three weeks before showing symptoms.

Tests in the UK have not revealed a link between Pandemrix and narcolepsy, although the Medicines and Healthcare Regulatory Agency said “a similar risk had only been confirmed in Finland and Sweden”.

‘Dropping forward’

Mrs Hadfield said her son “became a different boy” soon after receiving the vaccination, and Josh was also found to have cataplexy which makes his muscles collapse whenever he laughs.

She said: “Initially, I put it down to being the end of term, coming up to half-term week.

“He was tired and then he started losing muscle control so he couldn’t hold things properly.

“He needed you to support his hand because it was just dropping forward. It was horrible.”

In Finland, investigators found 79 vaccinated children and adolescents had developed narcolepsy, 12 times more than they would expect.

The Finnish government said it accepted a link between Pandemrix and narcolepsy and has promised compensation and support for affected families.

Health Minister Paula Risikko said: “We have decided to take these measures because the decision to acquire the vaccine was ours under the threat of a pandemic, and therefore we want to take the responsibility for the outcome.”

‘Genetic link’

The vaccine is manufactured by GlaxoSmithKline, whose UK medical director Dr Pim Kon said: “There is currently no evidence at all to suggest there is a causal link between Pandemrix and narcolepsy.

“We are working very hard with the regulatory authorities to try to understand what is happening.

“At the end of day, patient safety is of utmost importance to us and we wouldn’t ever put out a drug or leave it out there if we believed that it actually was a true issue.”

The European Medicines Agency said in July studies had shown a six to 13-fold increased risk of narcolepsy in children and adolescents vaccinated with Pandemrix compared with unvaccinated children.

But it added there appeared to be a link but the vaccine “is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and that other factors may have contributed to the results”.

And despite six million doses being administered, only seven children have been reported to have developed narcolepsy after taking Pandemrix in the UK.

But Mrs Hadfield believes there could be more families affected and has set up a Facebook campaign to try to track them down.

One such child is eight-year-old Lucas Carleton from Liverpool who has been off school for nearly a year and can sleep up to 20 hours per day.

His mother Pauline said: “He was a humorous little boy who used to make me laugh so much. He had a wicked sense of humour.

“All that’s gone and all that’s left is this angry frustrated little boy. It’s heartbreaking, absolutely heartbreaking.”

(Source: BBC)

An emergency medicine expert has called for an investigation into the danger to human health of feeding animals antibiotics to promote growth.

The president of the Australian Society for Infectious Diseases, Dr Thomas Gottleib, is worried about the flow-on effects on the food chain.

He says heavy use of antibiotics in animal health, agriculture and the medical world is feeding antibiotic resistance in humans.

“We’ve been using antibiotics since they’ve emerged in the 1950s as drugs that we can use on any occasion where there’s a potential infection,” he said.

“We’ve become very complacent with our use of antibiotics.

“There was an incredible use of antibiotics both in the medical world, in animal health and in agriculture, and all this large volume of use is feeding antibiotic resistance both in Australia and worldwide.

“We in Australia are not isolated from the rest of the world because the impact of antibiotic use anywhere in the world eventually impacts on us because we travel, and bacteria travel, and the risk of resistance developing is just becoming more and more evident.”

(Source: abc.net.au)