New Scientist: Did GSK trial data mask Paxil suicide risk?

This article is taken from leading science publication New Scientist:

An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data - a claim the company describes as "absolutely false".

Glenmullen's report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

Several pages from the report were withheld by the judge, but Chuck Grassely, a Republican senator for Iowa, wrote to GSK on 6 February asking that the missing sections be made public.

"With new questions about when GlaxoSmithKline knew about risks for suicidal behavior compared to when it let the public know about those risks, it seems like it'd be in the drug maker's best interest to provide every bit of information about this issue," said Grassely. "At this point, any sense that more information is being withheld only leads to more suspicion about what went on and what still might be going on. The public has a right to know what there is to know about this and other drugs."

The analysis focuses on the "washout" phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can't be attributable to the trial and so are seldom if ever included in final results.

However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra "placebo" suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults.

GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data "was intended to present the full picture of events that occurred in all phases of the clinical trials - starting from the time patients were enrolled, before they were randomised". She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn't respond to a request for numerical proof that Glenmullen's verdict was wrong.

Glenmullen suggests that the FDA would have acted differently had the use of the washout data been made more explicit. Rhyne says that material still under seal shows the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Brecher, the FDA official who reviewed Paxil's safety, as agreeing during a pre-trial hearing that the use of the washout data was "scientifically illegitimate".

Independent researchers say it was wrong to use washout data as GSK did. "I can't imagine circumstances in which it would be appropriate," says Bruce Psaty of the University of Washington in Seattle.

Sanofi dismisses GSK cancer vaccine as inferior

By Andrew Jack - Financial Times

Published: February 7 2008 02:00 | Last updated: February 7 2008 02:00

GlaxoSmithKline's rival has criticised as inferior its new cervical cancer vaccine Cervarix in an attempt to shore up an early lead in its competitor product.

Sanofi Pasteur MSD has been wooing investors this week with presentations claiming greater proved health benefits from Gar-dasil, which was developed by Merck of the US, in preventing human papilloma virus infections, the leading cause of cervical cancer.

Didier Hoch, head of SPMSD, a joint venture between Sanofi-Aventis and Merck for European marketing of vaccines, said published GSK results on Cervarix were less conclusive and dismissed as "a marketing gimmick" its clinical study directly comparing the two products.

Mr Hoch's charm offensive in London comes ahead of GSK's annual results presentation today, at which the UK pharmaceuticals company will face questions over delays in winning US regulatory approval for Cervarix.

It will be the last presentation by Jean-Pierre Garnier, who is stepping down as chief executive.

Gardasil has already been launched in the US and Europe, while Cervarix, which began development more recently, has been struggling to catch up. It received European approval last year but the Food and Drug Administration is still demanding extra information on Cervarix. This could delay its US launch as late as 2010.

Philippe Monteyne, head of global vaccine development at GSK, said positive and constructive exchanges were continuing with the FDA. "The scientific evidence shows we have the best possible cervical cancer vaccine . . . the confidence is there."

The fight between Gar-dasil and Cervarix reflects the importance of a fast-

expanding market for pharmaceutical companies for high-priced vaccines estimated to be worth billions of dollars in annual sales. Both products sell for about €330 (£247) for a course of three injections.

Mr Hoch said Gardasil had sold 3m courses in Europe last year and generated €342m in sales, making it one of the fastest-expanding and highest-earning laun-ches in recent years of any drug or vaccine.

He said Gardasil had dominated Cervarix, winning market share of more than 90 per cent in most important European markets. The exception is Austria, where Gardasil's share of the market is 88.8 per cent, which Mr Hoch said was partly because GSK had offered a discount, selling a course of Cervarix injections at €220.

He criticised GSK's head-to-head study of Cervarix and Gardasil for its small sample size, use of people older than the vaccine's target population, and use of a test of efficacy that was not standardised. He said claims that Cervarix would provide protection against a number of strains of HPV remained speculative

Thank you

Wow, I've just checked the blog after a long summer break. I am totally amazed to see my page hits are pretty steady, Glaxo, Pfizer and even the Economist have been reading. I'd just like to say thanks really! Especially to those who left rather personal messages on the Lamictal post, it makes me think maybe this wasn't just a university project and actually helped someone somewhere.I shall attempt to get the blog going again soon :)

GSK slammed over HIV ad's

hey guys....well the journalism project has ended. My hatred for GSK has not. Therefore im going to keep posting for anyone who may find this page!

I found this story on United Press International....would re write but I've got a History of Journalism exam on friday and should reeeeally be revising....here goes:

U.S. AIDS advocacy group the AIDS Healthcare Foundation blasted what it says are "fear-based" ads for HIV drugs by GlaxoSmithKline.
In the group's cross-hairs is a widely disseminated print ad by the drug giant designed to draw attention to evidence of a link between HIV and HIV drugs and a higher risk of kidney disease.

The ad, according to the AIDS group, uses the line, "He knows he has HIV. He doesn't know his HIV puts him at risk for kidney disease," and in smaller print, "Ask your doctor about your risk factors and the impact that HIV and its treatment may have on your kidneys,"

"At first glance, these GSK ads appear to warn HIV patients -- and HIV- infected individuals who may not yet be on treatment -- of the potential for kidney disease among people living with HIV/AIDS," said AHF President Michael Weinstein in a statement issued Wednesday.

"In fact, while kidney disease may be a consequence of HIV and its treatment, these GSK ads are a thinly veiled attempt to maintain market share for one of GSK's own AIDS treatments by scaring patients away from competing treatments which are associated with a slightly higher risk of kidney disease."

Glaxo win animal rights case

GlaxoSmithKline won a High Court injunction banning animal rights protestors from the doors of 18 of its bases including Stockley Park in Uxbridge and at Greenford in Ealing.

On Friday a High Court judge granted the company an injunction restricting protests by creating "exclusion zones" around their premises and banning harassment of workers.


Over the years GSK have become more and more frequently targeted by animal rights acitvists. The main reason for this is that GSK is the single largest customer of contract animal testing company Huntington Life Sciences. They use HLS for experiments every single day and have used HLS many hundreds of times.

Huntingdon has been under intense pressure since 1999, when a group of British animal rights activists set up Stop Huntingdon Animal Cruelty (SHAC) after massing amounts of evidence emerged showing how badly the animals in their care were treated. Video footag emerged of staff at various sites, punching, kicking and beating animals and in one severe case disecting a monkey whilst it was still alive. Apart from this physical violence reports have also found that animals when ill are left ill and dying, in theur own faeces and in severe pain.

This case raises an important question, one in which i've talked to some of you about before.

Is animal rights animals right activism having and the opposite desired effect? Looking around at news reports about the recent cases there is a clearly sympathetic tone toward Gsk and all is almost forgotton about HLS wrong doings and GSKs involvment.

Im not against animal testing, I do believe anything is worth a cure or relief for people who suffer. What I do stand against is unecessary and inhumane testing that takes place in HLS. None the less are GSK justified in complaining about the abuse they get from animal rights activisim?

If any of you are interested the website for Stop Huntingdon Animal Cruelty (SHAC) is here. On the whole these are passionate campaigners. The minority are getting them a bad rep. It will give you a bit more information about the campaign, news....and for those of you who can stomach it...video footage.

(Photo of vivisection on Monkey at HLS. Permission for use granted)

Smoking Update

1 month 2 weeks. No cigarrettes...but most importantly....No patches....No money for Glaxo or likewise drug companies :)

Glaxo too!

Well as many of you know (seeing as it was my most popular post...all of you are suckers for scandal), Pfizer Inc had been watching my page a rather alarming amount in past months.

Well, now GlaxoSmithKline, the target of my blog have joined in this ridiculous paranoid game.

It's good to know the money you spend on overpriced perscriptions is going to good use.

3 Charged over Glaxo Vaccine failure

Russian prosecutors have confirmed that three doctors have been charged for breaching medical procedures when testing GlaxoSmithKline vaccines. The vaccines have been now forensically proven to have been the cause for making several children suffering from various disorders extremely ill and furthermore causing deterioration in their existing conditions. Click here for my previous blog and background.

GSK who had previously vehemently denied any wrong doing are suddenly and unsurprisingly refusing comment on the recent news.

Glaxo Lied

Kindly borrowed from Seroxat Sufferers (see links)


March 27 (Bloomberg) -- GlaxoSmithKline Plc, the world's second-largest drugmaker, was fined NZ$227,500 ($316,000) by a New Zealand court after pleading guilty to misleading consumers about the vitamin C content of its Ribena blackcurrant drink.

The London-based company was also ordered to take out corrective advertisements in New Zealand newspapers, according to the Commerce Commission, the nation's commercial regulator, in a statement e-mailed to Bloomberg today. The regulator took Glaxo to court.

The claims about Ribena constituted a ``massive breach of trust with the New Zealand public,'' Commission Chairwoman Paula Rebstock said. ``As a multinational company specializing in pharmaceuticals and health products, they should have had robust testing and quality assurance systems in place,'' she said.

The court ruling comes a week after Australia's regulator, the Australian Competition and Consumer Commission, ordered Glaxo to stop making ``any express or implied representation'' that Ribena contained more vitamin C than orange juice products, and to publish notices on its Web site and at retail outlets advising consumers of the misleading statements about vitamin C.

Glaxo's consumer health care division, which distributes Ribena, the Horlicks-brand drink and Nicorette anti-smoking chewing gum, said it regretted any confusion caused in New Zealand.

``The fact that some of our products had incorrect labeling is to us, unacceptable, and we sincerely regret any confusion caused to customers who feel they may have been misled,'' the company said in a statement e-mailed to Bloomberg.

Ready to Drink

The company said the discrepancies over vitamin C levels only applied to its Ribena ready-to-drink product and not its syrup concentrate. Packaging for the ready-to-drink version had been changed to remove references to vitamin C and advertising has been revised to correct potentially misleading claims about the vitamin, the company said.

Shares of GlaxoSmithKline fell 1 pence 1,390 pence in London yesterday.

Glaxo's consumer health-care division generated sales of 2.9 billion pounds in 2005. It's the third largest in oral care and over-the-counter products worldwide.

Glaxo fined for predatory pricing

GlaxoSmithKline’s French unit was fined $13.2 million for hindering the use of generic drugs in hospitals through “predatory” pricing policy on an injectable antibiotic, French regulators said.

The Conseil de la Concurrence ruled that in 1999 and 2000 the Glaxo laboratory sold injectable Zinnat below cost to freeze generic drug manufacturers out of the hospital market.

GlaxoSmithKline spokesman Phil Thomson said the company would appeal.

“GlaxoSmithKline disagrees with the position taken by the French competition council and intends to appeal the decision before the Paris court of appeal,” he said.

It was the first case in France to penalize predatory pricing. Companies typically raise prices when competition has left the market, recouping whatever money was lost on below-market pricing. Information taken from www.fortwayne.com

I found this article somewhat mind boggling. I have been the first to slam drug companies for over charging but this article shows how under pricing can have just as negative effect. In the long and short this article is saying....

Glaxo produced the said drug so cheaply that other manufacturers could not compete therefore forcing them out of the market. This means Glaxo becomes solely responsible for producing that drug.

Well surely that's good for the general public I hear you say? Lower priced drugs? Well no, not truly. As stated at the end of the article once Glaxo has got rid of all its competitors it is then free to charge any price it pleases and usually like in many cases dramatically raise prices. In a similar case involving Pfizer a few years ago it actually found once that market competitors were eradicated through predatory pricing their drug in question eventually rose back to its original price and after a few months actually went on to increase by $2. As no one was offering it cheaper, they got away with it as people depended on the drug. This case was never even brought to trial or taken up as an official matter however for the people in the industry it is common knowledge things like are common occurrence. They never hit the courts let alone our news stands.

Some would argue it is also much healthier literally and in terms of economics to have a variety of similar drugs available. Certain brands have different side effects and therefore people who can't take Glaxo's drug were able to take other manufacturers. Having many manufacturers helps keep prices low, not just temporarily lower them. This situation also helps Glaxo maintain its super pharma giant status. One drug, one company, one price, one choice. Your only choice.

Drug companies squeeze profits out of the NHS

An office of Fair Trading (OFT) report says that the NHS is paying the pharmaceutical companies hundreds of millions of pounds too much for drugs. The Department of Health buys £7 billion worth of branded medicines each year from the big drug companies.

The OFT says the NHS is not getting the best prices for drugs and recommends the overhauling of PPR scheme which is supposed to set prices. Especially on drugs such as those to control blood pressure and cholesterol, it said "prices are significantly out of line with patient benefits."

Purchasing medicines and drugs takes up about a seventh of the NHS budget. The pharmaceutical companies are the most profitable sector of the economy with their rate of return dwarfing even those of the major banks or the oil industry.

Pharmaceutical giants still do not reveal how much of their profit comes from the NHS but estimates are high. Increasingly they are linked at the top with the Department of Health and Downing Street advisers.

OFT'S report may get a warm welcome from the Treasury that wants to make big savings on the NHS. However there will be ferrocious opposition from the drug giants and also from their men amoungst the governments ranks.

The Socialist workers party have argued they want an NHS that is able to carry out its vital work without shareholders profits being the biggest concern. The pharmaceutical companies and other industries making profits out of the NHS sch as the medical supplies industy, should be nationalised under democratic workers control and management.

I've quit smoking

Im currently attempting to quit smoking. I had decided to quit on thursday and then on wednesday the cash machine ate my card so I had no choice haha. I am glad though because the next time I return to my homeland of Wales for Easter the ban will be in place as of April 1st.

The ban which comes into place July 1st in England is going to be good news and mean big money for Glaxo who make Nicorette and NiQuitin amoungst a variety of other nicotine replacement products. Gordon Brown is also set to slash the VAT of these products in the coming budget as encouragment for more people to quit helping Glaxo even more.

Alas I have decided to go cold turkey. I tried patches a few years ago and they made me go slightly loopy. I found the side effects quite bad and they didn't relieve the need to smoke in the slightest. On the GSK website they say the side effects are nausea, dizziness, headaches, heart palpitations and insomnia. I obliged to let them know it turns you into a complete fruit haha. Most importantly though and out of principle I feel I shouldn't fund Glaxo.

I am using sheer willpower....wish me luck. Im dying for a ciggarette.


EDIT 29/03/07

Yesterday the Sun Newspaper reported a woman who had begun using Niquittin inhalers to combat her 40 a day addiction to ciggarettes. As a result however, and for the past three years she has become dependent on them getting through nearly as many as she did cigarrettes. She claimed the companies purposely made the products more addictive to boost profit.

Update: Its been like 2 weeks and no fags! I have added this lovely picture for my benefit...to remind me I used to smell. I regained my sense of smell and have gone through about 40 bottles of air freshner and washed everything possible! Uch a fi!(thats welsh for urgggh by the way)

UNICEF

For those of you who don’t know, when I’m not blogging Glaxo I can frequently be found working for Pell and Bales as a telephone fundraiser for many of the worlds largest charities. Currently and for the next few months I shall be working for UNICEF. The campaigns running are on Immunisation and HIV.

You frequently get people telling you to go fuck yourself when you ask for money however I had a few different objections lately. I had two ladies ask me about drug companies. Unlike most people who tell you to piss off these two women didn't want to give as it helped line the pockets of the drug companies UNICEF buy immunisations and anti retro viral drugs from.

How on earth do you respond to that? I mean I agree. I shamelessly plugged my blog and said fair enough. I will probably get sacked if I keep doing it but I don’t care. They were right. Nothing will change with the situation as it stands. I am not saying withdraw aid to developing countries. But more lobbying needs to be done. Only 60% of the worlds children are immunised against basic diseases such as polio, tetanus, and measles. 40% of immunisations are done by UNICEF. Why should it be left to charity. This is not a criticism of just the drugs companies but also government bodies.

What do you think? Should UNICEF and other charities co-operate with the Pharma companies? Should there be an independent body to provide drugs for the developing words, even the Western world?

Pfizer are watching!

For all of you who don't know Pfizer are the worlds biggest drug company. A bigger fish than my beloved and blogged Glaxo. Pfizer Inc, New York has visited my pages over 10 times in the past 24 hours. It took them less 8 hours after making my first post to find the site.

I personally find it quite creepy, however I suppose it's only fair that if there are watchdogs for the Pharmaceutical companies that there be watchdogs for the watchdogs. However I think viewing my page with hourly intervals 10 times a day is a bit excessive in terms of surveilance!

I do urge whoever you are watching to join in debate, it wouldn't be fair otherwise, we'd greatly appreciate you're opinions. However if you are just her to monitor me because your company doesn't like negative comments made, about things such as the controversial accusations over the deaths your drug Trovan allegedly caused in unconsented trials, well you know what you can do....just learn some morals and don't make such grievous errors in the first place.

Any comments from Pfizer or otherwise welcome

EDIT: In the few mintues it took me to write this comment and post it....I can see Pfizer have visited the page twice. And not just Pfizer UK, Pfizer New York....Quick work. Nice touch.

The drugs DON'T work

A shocking revelation was made by GSK a few years ago and I feel that anyone who takes the time to read this blog should be made aware of this.

A senior executive of Glaxo admitted "Our Drugs Do Not Work on Most Patients"

Allen Roses, then worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them.

It is an open secret within the drugs industry that most of its products are ineffective in most patients but this is the first time that such a senior drugs boss has gone public. GSK also announced it had 20 or more new drugs under development that could each earn the company up to $1bn

The bombshell came when Dr Roses, an academic geneticist from Duke University in North Carolina, spoke at a recent scientific meeting in London where he cited figures on how well different classes of drugs work in real patients.

Drugs for Alzheimer's disease work in fewer than one in three patients, whereas those for cancer are only effective in a quarter of patients. Drugs for migraines, for osteoporosis, and arthritis work in about half the patients. "Most drugs work in fewer than one in two patients mainly because the recipients carry genes that interfere in some way with the medicine", he said.

"The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people."

Children harmed by GSK vaccine trial

A huge ethical issue raised through pharmaceutical companies is gaining consent. GSK are not the only company to come under fire in this area. One famous case was the company Pfizer trials for Trovan in Nigeria. The company was sued after 11 children died during the trials for their drug. The families claim they were unaware they were taking part in a trial and had not given consent.

Currently a similar investigation is taking place with GSK. News from Russia has worryingly revealed that a local hospital and GSK are being investigated on suspicions it illegally tested vaccines made by GSK. Parents and children have claimed those who took part have become seriously ill and their development severely hampered.

Glaxo vaccines were tested on more than 100 toddlers at the hospital in Volgograd, Russia. Prosecutors claim parents were made to believe these were routine vaccinations and were most certainly not made aware it was a drug on trial. According to the prosecutors, Glaxo paid the clinic in southwestern Russia $50,000 to conduct the trials, which made many children ill.

Furthermore GSK did not follow the trial contract guidelines which clearly state only healthy children can take part in the trials.

Spokeswoman for the Volgograd region prosecutors, Lydia Sergeyeva said:
"Many of the children sent for trials had been diagnosed with diseases. They (GSK) had no right to put children with health problems through these clinical tests. It can lead to a deterioration in the child's condition, which has happened in the case of some of these children.”

The prosecutors told of a 2 year-old girl whose neurological illness progressed sharply after she was vaccinated. The girl can hardly speak and shows other signs of arrested development.

GSK denied the claims and said there was no evidence of adverse events or misconduct in the way the study had been carried out. A company spokeswoman said its own internal audit showed informed consent had been given by all parents and doctors involved in the trial. However as the situation stands and with compelling evidence shown GSK could be facing court.

Background to the Blog

Hello and welcome to GlaxoSmithKline News.

UK based GlaxoSmithKline are Europe's largest pharmaceutical company and second largest in the world only recently overtaken by Pfizer. As it stands the pharmaceutical sector is the highest profiting sector of the economy and in 2006 alone GSK made a profit of £7.8 billion.

GSK like many of the worlds leading pharmaceutical companies have come under criticism on various grounds. With this blog I hope to highlight some of the ethical issues raised within GSK and the pharmaceutical sector.

I will look at issues varying from animal testing, unconsented trials, drug safety amongst other areas. I will attempt to be as honest and unbiased as possible but I will make no lie of it. I do not like GlaxoSmithKline. In my opinion, with strong reason I believe the pharma industry literally make money out of people dying for drugs.

I hope after reading the entries next time you drink your Lucozade or Ribena, brush your teeth with Aquafresh or take that Solpadine for your hangover you are aware of what your money funds.