GSK’s Tafenoquine…

Soldiers Anticipate Long-Awaited Report Into Anti-Malarial Drugs

Defence force personnel left with debilitating psychological effects from taking anti-malarial drugs are looking forward to the release of a long-anticipated report into the use of two separate medications.

Anti-malarial products mefloquine and tafenoquine have been prescribed for Australian defence personnel — as well as general civilians — for many years.

While mefloquine was registered with the Therapeutic Goods Administration as early as 1988, with tens of millions of prescriptions globally, recent years have shone a light on the drug’s potential side-effects.

A months-long federal government inquiry into the use of the two drugs, and any “adverse health effects” of their use, is due to report this week after being twice delayed.

The Department of Defence outlines that most symptoms are “minor”, and can include sleep problems, vivid dreams, anxiety and depression. In around 10 percent of cases, the department said, users can experience dizziness or headaches.

In one percent of cases, the department noted, side-effects can include “agitation, restlessness, mood swings, panic attacks, confusion, hallucinations, aggression, psychosis and suicidal ideation”, as well as balance problems and seizures.

(Getty Images)

The American Food and Drug Administration (FDA) added warning labels to mefloquine products in 2013, warning of possible psychological issues including dizziness, balance issues or ringing ears.

Much attention has been paid to the use of the drugs by defence force personnel around the world, including in the US and UK, with countless members sharing personal stories with journalists.

More than 1300 ADF members were prescribed mefloquine in a trial in Timor Leste in the early 2000s, while others — including retired army officer Stuart McCarthy — were given the drug, and another called tafenoquine, in other overseas missions to developing countries to combat malaria.

(Getty Images)

“I had a lot of chronic health issues that I could never really get to the bottom of. I was given tefenoquine in Bougainville in 1999, and I didn’t really think much of it connected to the subsequent health problems I had,” McCarthy told 10 daily.

“Even though I was given a very high dose during the trial, and the purpose was to eradicate malaria, I still got malaria regardless.”

McCarthy said he also later developed a range of serious psychological conditions, including depression, and other “subtle but noticeable” issues like vertigo and what he classed as general “cognitive decline”.

He claimed up to 3000 people may have been affected by these drugs, saying he had spoken to “hundreds” of families and was aware of some suicides allegedly linked to the use of the anti-malarial drugs.

“The evidence now is these drugs can cause a permanent brain injury. There’s a very distinctive set of symptoms including psychiatric ones, like depression, anxiety, and neurological symptoms,” he told 10 daily.

“The drug trial I was involved in, tafenoquine, my experience was there was very little if any info on side effects, other than you might have some gastro for a few days. There was no mention of possibility of brain damage.”

(Getty Images)

Around 140 Australian personnel were prescribed mefloquine between 2010 and 2016, according to the defence department.

“A Senate report will be released today on the use of anti-malarial drugs, which has had direct input from veterans throughout Australia and I look forward to reading the findings,” Veterans Affairs minister Darren Chester told 10 daily on Tuesday.

“I am focussed on putting veterans and their families first and delivering the essential services they rely on, with more than $11 billion provided each year.”

The Senate inquiry into ‘Use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the Australian Defence Force’ attracted nearly 140 submissions.

Those who used the drugs have complained the drug trials were incorrectly administered, and that the government has not provided appropriate access to health or support services to deal with ongoing side-effects.

“There is clear, extensive evidence of the harmful effects of mefloquine and tafenoquine, including lasting impact on many hundreds of Australian quinoline veterans and their families,” the Quinoline Veterans and Families Association (QVFA) said in its submission.

“Despite claims by Commonwealth officials that adequate help is available, the government has consistently denied the fact that these drugs are able to cause permanent brain damage resulting in widespread chronic neuropsychiatric illness and in some cases suicide.”

“There is a compelling need for the Commonwealth to implement a comprehensive program of outreach, rehabilitation and research, led by experts in ABI and clinical neurotoxicology.”

(Getty Images)

In its own submission, the Department of Defence defended the use of mefloquine, saying it was not commonly used and only as a “third-line” treatment when people could not use two other more popular treatments.

But it acknowledged side-effects had been experienced by some personnel.

“Defence has always acknowledged that mefloquine can cause side effects, including neuropsychiatric problems, while individuals are taking the drug,” the department wrote.

“Generally, symptoms will disappear when the individual stops taking the drug but they can persist for some time afterwards due to the drug’s long half-life of two to four weeks. Defence also acknowledges that neuropsychiatric side effects have been known to continue and become long term in a small number of individuals.”

The Senate report is due to be delivered this week.

McCarthy acknowledged concerns raised by himself and others affected by the drugs had been well-received by federal officials, but said the government needed to take action.

“There needs to be a royal commission,” he told 10 daily.

“Most important, we need dedicated outreach and rehab programs for people affected by these drugs. We want the government to set up a program of referrals, so anyone with these symptoms can be referred to the appropriate medical specialist, and also appropriate social support.”


Are GSK’s Experimental Malaria Drug Tafenoquine And Roche’s Mefloquine (Lariam) Neurotoxic?


“…British soldiers are being given a controversial malaria drug that carries a higher risk of depression, anxiety and psychosis compared to its alternatives, an inquiry heard yesterday.

Dr Frances Nichol, of drugs manufacturer Roche, admitted to the Defence Select Committee that the drug Lariam, used by the military, had worse side effects than other common anti-malarials.

She warned that the drug should not be prescribed to soldiers with pre-existing conditions. But another Roche spokesman admitted there was a ‘risk’ that military personnel might not disclose previous mental health problems to officers for fear of damaging their careers…”

Daily Mail 2015

Roche’s anti-Malaria drug Mefloquine (which goes under the trade name Lariam) is a Malaria drug which has been dogged by controversy for at least a decade now. Roche were sued in Ireland recently because of the neuro-toxic effects of Lariam (there was an out of court settlement).


In proceedings initiated in 1999, Mr Bryce sued Roche Products (Ireland) Ltd; a medical doctor and Executive Medical Care Ltd, trading as Grafton Street Medical Centre, for damages for allegedly failing to warn him of all of the side-effects of the drug.

Mr Bryce claimed his delay in prosecuting his action was allegedly due to poor health since having taken the drug.

Mr Bryce had claimed he took Lariam prior to his honeymoon in Kenya in 1996.

He claimed he suffered panic attacks and dizziness and his health had deteriorated after returning from his honeymoon….”

The neuro-toxic effects of Roche’s Lariam have been well documented now, however GSK are developing their own anti-Malaria drug (which has yet to be fully licensed) called Tafenoquine.

Tafenoquine is in the same class of drug compounds as Mefloquine and there has been speculation that Tafenoquine could be even more neuro-toxic than Mefloquine (Lariam).


Dr Remington Nevin has been studying the neuro-toxicity of these drugs and there seems to be a lot of concerns raised about GSK’s Tafenoquine…

After the devastation caused by GSK products such as Myodil, Avandia, Seroxat and Pandemrix  I think the public have a right to be concerned when GSK claims to have made a breakthrough drug don’t you?…

Seroxat (Paxil) was marketed as a breakthrough wonder drug for the treatment of depression and anxiety in the late 90’s but it wasn’t long after that people began to realize that Seroxat was closer to a killer drug than a wonder drug…

I will be keeping my eye on  GSK’s Tafenoquine…

Personally I wouldn’t touch any GSK drug with a barge pole..


“…Through post-trial ­research, the ADF has confirmed mefloquine can cause side effects likened to that of PTSD, including agitation, mood swings, panic attacks, confusion, hallucinations, aggression, psychosis and suicidal thoughts in a small number of patients.

But Dr Remington Nevin, a leading international expert on mefloquine and tafenoquine, told the audience via Skype that the “information in the ADF consent forms undermined critical manufacturer’s safety information and understated known risks”.

He also said ADF subjects were not given information to allow for fully informed ­consent, attributing both failures to soldiers “experiencing lasting harm from the drug”.

AVM Smart the forum was a “step in the right direction” and provided important ­dialogue to inform “the next steps”.

“It was really beneficial to be able to listen and understand the experiences of those who attended so we can work on further reducing the barriers both current and ex serving members might encounter when trying to seek help,” she said.

The Department of Veterans Affairs declined to attend the forum….”




Check out the following links on

GSK’s Tafenoquine And Roche’s Mefloquine:


GSK’s Raxar Was Withdrawn In 1999.. So Why Won’t They Withdraw Seroxat?

I have been campaigning for almost a decade now about Seroxat and GSK, and as each year passes I am still astonished that GSK have been allowed to keep Seroxat/Paxil (Aropax/Paroxetine) on the market. It is simply a killer drug with risks that far outweigh any perceived benefit. GSK’s Raxar drug was withdrawn in 1999 because of a supposedly very rare risk, and GSK’s Seroxat PIL (patient information leaflet) has grown into a litany of side effects, many of which are not rare, but are actually very common. GSK’s Raxar was apparently linked to 13 deaths, however GSK’s Seroxat has a body count which is far far greater, and the worst thing is, many tens of thousands are trapped on this killer drug because of its addictive properties. The link between Seroxat and birth defects has been established for some years now also.

Seroxat has been banned for use in under 18’s because it makes them want to kill themselves, and it causes self harm. There have also been reports of risks of suicide etc in ‘young adults‘. Those of us who have extensive experience with Seroxat (and those who have been harmed by Seroxat) know that these serious side effects occur regardless of age- so why is Seroxat still on the market? How can the regulators justify the continued sale of this deadly drug when other drugs have been withdrawn for a lot less?

November 1, 1999

Dear Health Care Provider:

Withdrawal of Product: RAXAR( (grepafloxacin HCl) 600 mg Tablets, 400 mg Tablets, and 200 mg Tablets

Glaxo Wellcome has voluntarily withdrawn all licensed formulations of RAXAR and the product is no longer available from pharmacies.

RAXAR is a fluoroquinolone antibiotic indicated for the treatment of infections caused by strains of bacteria susceptible to grepafloxacin in the following diseases: community-acquired pneumonia; acute bacterial exacerbations of chronic bronchitis; uncomplicated gonorrhea (urethral in males and endocervical and rectal in females); non-gonococcal urethritis and cervicitis.

Glaxo Wellcome has recently concluded an extensive review of the safety of RAXAR and determined that due to an effect of RAXAR on cardiac repolarization, manifested as QT interval prolongation on the electrocardiogram (ECG), some patients may be at risk of a very rare but serious ventricular arrhythmia known as torsade de pointes when treated with the product.

Although torsade de pointes has been reported very rarely in patients taking RAXAR, it is considered by the Company that the therapeutic benefit of treatment with RAXAR may be outweighed by the potential risk to patient safety, especially given the availability of alternative treatments.

For patients already commenced on a course of RAXAR, careful consideration should be given to switching the patient to an alternative antibiotic therapy.

If you have any samples of RAXAR in your possession, you may either contact Glaxo Wellcome to request self-addressed, postage-paid boxes to facilitate returning samples to Glaxo Wellcome, or you may dispose of any remaining RAXAR samples in the usual and customary way that you dispose of expired or damaged samples.

If you would like to request boxes, or for more information, please contact the Glaxo Wellcome Customer Response Center at telephone number 1-888-TALK-2-GW (888-825-5249).


Richard S. Kent, MD
Vice President – US Medical Operations
Glaxo Wellcome Inc.


Raxar, also known as Grepafloxacin hydrochloride, is used to treat bacterial infections such as pneumonia and gonorrhea. It is marketed by GlaxoSmithKline. The FDA approved the drug in November 1997. Raxar was withdrawn from the market in October 1999 because of its effect on QT interval prolongation which can lead to cardiac events and sudden death. Severe side effects include difficulty breathing, closing of the throat, hallucinations, irregular or slow heartbeats, muscle or joint pain, and liver damage. Common side effects include headache, nausea, diarrhea, ringing of the ears, drowsiness or insomnia. Sales in the U.S. generated $23.5 million in total revenue for the GlaxoSmithKline. Clinical trials indicated heart arrhythmia in patients using 600-milligram doses which resulted in death; however, patients using 400-milligram doses did not manifest the irregularities. Individual lawsuits were filed as a result of 13 deaths attributing to the use of Raxar. Settlements were reached with the individual plaintiffs in the fall of 2000.

Raxar (Grepafloxacin)

Development and Release

Raxar was developed by Otsuka Pharmaceuticals and licensed for sale to GlaxoWellcome (which became GlaxoSmithKline in 2000) as an antibiotic used to treat certain bacterial infections such as pneumonia and gonorrhea. The U.S. Food and Drug Administration (FDA) approved Raxar for sale to the general public in November of 1997. In the short time it was on the market before it was deemed too dangerous for sale, the product generated $23.5 million in sales in the United States.

Health Problems Associated With Raxar

In reports presented to the FDA at the time of Raxar’s approval, there were concerns that the drug caused heart-rhythm disturbances in patients. Although such irregularities did not occur in patients who took the 400-milligram dose of Raxar during the clinical trials, four of the subjects taking 600-milligram doses died as a result of a heart arrhythmia soon after withdrawing from the clinical trial. Glaxo and the FDA then sought to minimize the risk of harm to any individual through precautionary labeling.

Glaxo’s Response

While it was not clear at the time that Raxar was the culprit at the time of approval, one FDA medical officer noted that the question was “open.” Still, Glaxo maintained that the heart arrhythmia was not caused by Raxar and highlighted the fact that there were no “deaths or permanent disabilities” to patients who took the drug at 400-milligram doses. Conspicuously missing from the warning label, however, were the deaths that occurred in clinical trials to patients taking the 600-milligram dose.

According to the FDA, an estimated 13 people died as a result of their Raxar prescription. Most of the fatalities associated with Raxar were in patients under 70 years of age, with no reported prior heart irregularities. In October of 1999, almost two years after the product came to market, Glaxo pulled Raxar from shelves. The company issued an accompanying statement that it was “no longer convinced that the benefits of Raxar outweigh the potential risk to patients.”

Legal Response

Because so relatively few were exposed to Raxar’s risks, just 13 deaths were attributed to the drug—a relatively small number in the context of dangerous drug litigation. Glaxo reportedly reached individual settlements with the plaintiffs in the fall of 2000.

The Irony… GSK working on Asbestos disease-drug…

Further to my post yesterday about GSK asbestos contamination in GSK drugs made at a GSK Stiefel Site In Sligo, and the whistleblowers who claim that they also have been affected from Asbestos contamination, it seems that GSK is making a drug to help ease the conditions from Asbestos related diseases… Ironic? Yes, Very…

New Drug Targets Cancer Caused By Asbestos

May 26, 2014

Mesothelioma lung cancer can come to those persons who loved, and simply hugged their parent who worked around asbestos.  For example, now at age 45, Heather Von St. James recalls her father working as a building demolition employee around materials containing asbestos.  He would return home each day thoroughly covered by dirt and dust. She remembers how much she enjoyed hugging her father each night.

By age 36, Heather was diagnosed with mesothelioma, the deadly yet to be cured cancer connected with exposure to asbestos particles.  Mesothelioma can take decades to develop and it often kills within months after symptoms appear. Heather was a new mother to a 3-month-old daughter, and she was told her only chance to live was by having a lung removed.

In 2013, more than 107,000 people died worldwide from mesothelioma.  However, Heather opted for the surgery instead, and removed the disease in time to stay alive.   According to Ms. St. James, “There’s a lot of people who don’t.”

Fortunately for other people with mesothelioma, or those that will discover they have the deadly disease, a new wave of drugs developed and being tested are giving new hope that mesothelioma cancer may be slowed or stopped.  Drug researchers, like Verastem Inc. (VSTM), GlaxoSmithKline Plc (GSK), and Dr. Parkash Gill of the USC Norris Comprehensive Cancer Center have announced that they are testing new cancer fighting drugs.

Carolyn Buser-Doepner (VP for tumor signaling at Glaxo, the U.K.’s biggest drugmaker), there are plans to combine a new drug GSK2256098 with some other medicines to potentially make cancer treatments more effective.  In one early-stage trial, it will be paired up with Glaxo’s Mekinist, which is approved for melanoma.  She said, “The pre-clinical data are very encouraging. We’re very excited about it.”

GSK Recalls ‘Alli’ Drug Due To ‘Drugs In Wrong Bottle’ Mix Up!…

Andrew Witty! CEO of The Year!...
Reminds me of the Cheryl Eckard Scandal...–finance.html


The GlaxoSmithKline logo is seen at the entrance of a building in Luxembourg

By Ben Hirschler

 LONDON (Reuters) – GlaxoSmithKline is recalling all supplies of its non-prescription weight-loss drug Alli in the United States and Puerto Rico after customers reported finding other pills and tablets in some bottles.

The news is a fresh blow for a product once touted as a potential blockbuster but which has had disappointing sales over the years – aggravated, in part, by a separate supply problem two years ago.

The British group said it believed that some U.S. bottles of Alli might not contain authentic product, adding that it was working with the U.S. Food and Drug Administration on the retailer-level recall.

News that bottles had been tampered with first emerged on Wednesday.

GSK has received inquiries from consumers in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas about 20 bottles containing tablets and capsules that were not Alli.

The treatment is also sold in Europe but the company said no problems had been detected there and European sales were not affected by the U.S. recall.

GSK said it was not immediately clear how the bottles had been tampered with or where in the supply chain the problem had occurred.


“The investigation is ongoing. We’ve asked people to return bottles to us, so we can examine them very closely … we don’t have any theories at this point,” a company spokeswoman said.

Shoppers said they had found a range of tablets and capsules of various shapes and colors in purchased Alli containers. The authentic drug is a turquoise-blue capsule. Some bottles inside the outer carton were also missing labels and had tamper-evident seals that were not genuine.

There have been no reports of any serious illnesses related to the product after news of the tampering.

Quality problems have become a big issue in the pharmaceuticals industry, with most attention focused on Indian generic prescription drug suppliers. However, Western groups such as Johnson & Johnson have also suffered failures in quality control.

Alli is marketed by GSK’s consumer healthcare business and is approved for over-the-counter (OTC) sale for overweight adults, in conjunction with a low-fat diet.

The treatment, which is a low-dose version of Roche’s Xenical, was launched in the United States in 2007 with a big marketing campaign. But the product has failed to achieve the $500 million to $1 billion of sales analysts had initially forecast.

GSK no longer breaks out Alli sales figures, though revenue from the product was 93 million pounds ($154 million) in 2011.

The company tried to sell the Alli brand that year, along with a number of other non-core OTC healthcare products, but its divestment was scrapped after an interruption in supplies from Roche, which makes the active ingredient for the drug. ($1 = 0.6037 British Pounds)

(Editing by David Goodman)

Remembering Glaxo’s Infamous Study 329 : The Paradigm of Fraudulent Pharmaceutical ‘Ghost Writing’

October 8, 2012

‘Any Reasonable Person’ Would See Glaxo Study as Fraud

To the Editor:

Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement” (The Chronicle, August 6) raises the correct questions about GlaxoSmithKline’s recent $3-billion settlement with the Department of Justice. But in a letter from its attorney Thomas H. Lee II (“Journal Article Didn’t Mislead, Drug Company Asserts,The Chronicle, September 23), GlaxoSmithKline seizes on a one-line “escape clause” from the July 5, 2012, plea wherein another of Glaxo­SmithKline’s attorneys states that GlaxoSmithKline “agrees that there’s a sufficient factual basis to support the guilty plea,” but the company “is not by that guilty plea agreeing to each and every factual allegation that’s set forth in the information.”

This is a standard maneuver in plea agreements, but it does little to change the role that Study 329 played in the fraudulent conduct. Any reasonable person who examined the reporting of Study 329 (“Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized Controlled Trial,” published in the names of Martin Keller et al. in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001) would conclude the article was false and misleading and part of the fraud. We also find it interesting that GlaxoSmithKline cc’d the journal’s current editor, Andrés Martin, on Mr. Lee’s letter at a time when Dr. Martin was being pressured by demands from the international scientific community to retract the article.

Mr. Lee’s response to The Chronicle’s article claims “to correct some significant factual inaccuracies.” In turn, we wish to respond to some inaccuracies in Mr. Lee’s letter.

Having been engaged by the plaintiffs’ law firm, Baum, Hedlund, Aristei & Goldman, to provide an independent evaluation of the reporting of Study 329, we studied over 10,000 pages of confidential documents relating to Study 329 and published four papers in medical and bioethics journals on our findings. While Mr. Lee admits Glaxo­SmithKline hired a medical writer to provide “editorial assistance to the clinical investigators,” he claims that GlaxoSmithKline “believed then and continues to believe that the journal article reflects the honestly held views of the clinical-investigator authors.”

In fact, Sally Laden of Scientific Therapeutics Inc. testified in her deposition that she wrote the first draft of the manuscript from a summary provided by GlaxoSmithKline. We are not sure what Mr. Lee regards as “substantial comments on and input into the manuscript,” but the documents we saw show clearly that the minority of named “authors” who made any contribution to the manuscript at all provided little more than “editorial assistance” to Ms. Laden. A comparison to the published paper shows that few significant changes were ever made to Ms. Laden’s first draft.

Contrary to GlaxoSmithKline’s claims, control over the contents of the manuscript did not remain “at all times with the clinical-investigator authors.” In accordance with GlaxoSmithKline’s corporate intellectual-property policy, since the company paid for the trial, the data, and the manuscript, it was the company’s intellectual property, which GlaxoSmithKline only transferred to the “lead author” once the paper was ready to be submitted for publication. The ghostwriter, Ms. Laden, continued to manage the manuscript throughout the process, under guidance from GlaxoSmithKline. This allowed Glaxo­SmithKline to control the message, minimizing the possibility of a contrary view by an “author” who might compromise the company’s manipulation of the data. The investigators signed off on the manuscript without seeing the raw data from the trial.

Only a fraction of the thousands of documents concerning Study 329 that we reviewed have been released into the public domain, a subset of which can be found on the Web sites of Healthy Skepticism and the University of San Francisco’s Drug Industry Document Archive. If GlaxoSmithKline is serious about “vigorously disput[ing] that the journal article was false, misleading, or fraudulent,” the company should release the rest of the documents concerning Study 329 so the public can judge whether the results of Study 329 were reported honestly and accurately in the journal.

The journal article on Study 329 has become the paradigm case of medical ghostwriting, one that facilitated the misrepresentation of study results for both efficacy and safety, and as a result harmed young patients who were prescribed Paxil in reliance on this article. The fact that GlaxoSmithKline continues to dispute vigorously the report of this study demonstrates, in our view, that the company is still out of step with the companywide overhaul initiated by the new CEO, Andrew Witty, to prevent “unacceptable” mistakes that led to the record $3-billion fine.

Leemon B. McHenry
Department of Philosophy
California State University<
Northridge, Calif.

Jon N. Jureidini
Discipline of Psychiatry
University of Adelaide

Remembering Sharise Gatchell: A Seroxat Induced Suicide

This web site is dedicated to my late sister Sharise Gatchell.

Sharise committed suicide on the 25th May 2003…age 18… Sharise had been prescribed the anti-depressant Seroxat, also known as Paxil in the U.S.

I really thought she would become a famous artist.. Sharise had so much talent and energy, Seroxat took that all that away… after only 17 days on Seroxat, she hanged herself from the loft hatch in my parents home…

My mom and dad found her on their return from a weekend trip in Scotland… Sharise knew very well that my parents would not let her go back on Seroxat and so she took it secretly. The first time she was prescribed the drug at the age of 16, she started self harming, cutting her arms, something that had never ever happened before. She was never the same again.

2 years later Sharise felt really down and in desperation went to see a GP. Unwittingly a new doctor prescribed my sister Seroxat again. The previous doctor never bothered to add to the medical records that Seroxat had caused Sharise to self harm, even after my mother made a great deal of effort to make her aware of the issue.

The drugs manufacturer GlaxoSmithKline has finally admitted that Seroxat can cause some people to have suicidal thoughts and tendencies when on the drug.. Thanks for letting us know 2 weeks after her death. Congratulations for raking in billions of pounds while you poison our society with your wicked “treatments” that are now turning out to be less beneficial than a placebo. I wish immense stress and bankruptcy on all of you.

My family and I will spend the rest of our days making people aware of the enormity of your greed, and your selfish disregard for human life… we shall NEVER stop…

Footprints In the Snow:

We fall to the earth like leaves
Lives as brief as footprints in snow
No words express the grief we feel
I feel I cannot let her go.
For she is everywhere.
Walking on the windswept beach
Talking in the sunlit square.
Next to me in the car
I see her sitting there.
At night she dreams me
and in the morning the sun does not rise.
My life is as thin as the wind
And I am done with counting stars.
She is gone, she is gone.
I am her sad music, and I play on, and on, and on.
(Roger McGough)

GSK at it again? …GSK Drug Rep Found Guilty of Promoting Drug For Unlicensed Use…

Just months after paying a record-breaking 3 Billion dollar fine for fraud with the Dept of Justice in the US- a GSK drug rep is found guilty of promoting a GSK drug for unlicensed use-

The Guardian Reports: 

GSK sales representative found guilty of promoting Revolade for unlicensed use in serious breach of industry code of practice:

  • The Guardian, Monday 12 November 2012 19.49 GMTJulia Kollewe

    GlaxoSmithKline sales representative has been found guilty of promoting a medicine for an unlicensed use, just months after the drugmaker was fined a record $3bn for mis-selling drugs in the US.

    GSK chief Sir Andrew Witty had vowed a company-wide overhaul would prevent a repeat of the mis-selling of the Paxil antidepressant for unlicensed use on children and other illegal practices.

    But in another blow to the drug giant, a GSK employee has blown the whistle on a sales rep’s promotion of the use of the Revolade blood disorder drug for myeloid fibrosis, a bone marrow disease for which it has no licence. The employee said a company salesperson had promoted the drug to an NHS consultant in an email.

    The email suggested dates for an appointment to “discuss putting together the individual funding request for your patient with Myeloid Fibrosis”. But the medicine has only been approved to treat a bleeding disorder called immune (idiopathic) thrombocytopenic purpura in patients whose spleen has been removed.

    The Prescription Medicines Code of Practice Authority, which polices the Association of the British Pharmaceutical Industry’s code of practice, investigated the GSK employee’s claims and ruled that the drugmaker had breached three clauses. The first clause states that companies cannot market a drug off label, for example outside its licence; the second that high standards must be maintained at all times; and the third that sales reps must adhere to high ethical standards and comply with the code.

    A PMCPA spokeswoman said the drugmaker had to undertake to avoid a similar breach of the code in future and ensure its systems are changed accordingly.

Promises Promises… GlaxoSmithKline and Andrew Witty…

A couple of days ago I drew attention to some comments on the Guardian article about GSK’s promise of increased transparency in its business model. I am certainly not the only one who is cynical about GSK and its company Chief Executive, Andrew Witty. GSK have operated like a criminal cartel, people have died because of their  illegal and unethical corporate behavior. It would be foolish to believe anything coming from their direction, now or in the future. 

From the ‘Seroxat Sufferers’ Blog, Bob Fiddaman Writes :

15 Good Reasons Not to Trust Andrew Witty and GSK

GSK Head, Andrew Witty and his recent announcement about transparency could possibly be believed if one were inclined to be gullable. See here, Glaxo’s Murky Transparency Claim

He blamed the recent $3 billion guilty plea for off-label promotion of GSK drugs that not only harmed but killed people on an era. See here, GlaxoSmithKline: The Andrew Witty “Era”

Do we, as consumers, really think Andrew Witty is being sincere with his latest offering? He, as recent as last year, refused to meet with Janice Simmons, founder of the Seroxat User Group, to discuss the 15,000 emails she has amassed from patients who are struggling to withdraw from his company’s antidepressant, Seroxat. See here, **Exclusive – GSK’s Andrew Witty in Patient Aftercare Snub

Witty’s backroom staff and predecessor’s have also made promises and outrageous statements in the past.

Glaxo, and indeed other pharmaceutical companies, are always telling doctor’s and patients about the benefit vs risk of taking their antidepressant medications.Like Witty, I’m coming up with my own benefit vs risk ratio. Can he, or indeed his company, GSK, be trusted to deliver the goods this time around?History would suggest otherwise.

And from the ‘Seroxat Secrets’ Blog:

Trust GlaxoSmithKline?

Trust GSK? – you must be mad.

Sarah Boseley in The Guardian writes:

“The British drugs company GlaxoSmithKline is to open up the detailed data from its clinical trials to the scrutiny of scientists in a bid to help the discovery of new medicines and end the suspicions of critics that it has secrets to hide.

In a speech today [11 Oct] to the Wellcome Trust in London, the chief executive, Andrew Witty, will say openness to the public and active collaboration with scientists and firms outside GSK are essential to finding new drugs to treat the diseases plaguing the world, from novel antibiotics to cures for malaria and tuberculosis.

He told the Guardian GSK had already done much to advance transparency in clinical research, including publishing a summary of every drug trial – whether a success or not – on its website

Said Sir Mark Walport, director of the Wellcome Trust – “In its commitment towards more openness and collaboration, GSK is setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other. GSK’s moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today.”

But hold on a minute – Dr Ben Goldacre’s not sure about GSK :

“But we should judge drug companies by their actions, not by their promises, especially when similar promises have been made in the past, and then broken.

In 1998 GlaxoWellcome promised to set up a clinical trials register, amidst outcry over withheld trial results. But when the company merged with SKB to create GSK, in 2002, this register was unceremonially deleted from the internet. This tragic story is described in aexcellent open access article on this history of attempts to get access to hidden data, by Iain Chalmers.

Then, in 2003, GSK were caught withholding clinical trial data showing that their drug seroxat increases the risk of suicide in young people. As part of the settlement on fraud charges, in the US in 2004, GSK were forced to promise to post all trial results on a public website. But in 2012 GSK paid a new $3bn fine for criminal and civil fraud: this included charges over withholding data on the diabetes drug Avandia, as late as 2007, well after this earlier promise of transparency was made”.

That’s a pretty poor record, I’m sure you’ll agree.

As far as GSK is concerned, talk is cheap and promises are routinely broken with no compunction whatsoever.