Will GSK ever atone for their Myodil scandal?
Will GSK ever atone for their Myodil scandal?
It seems the only way for us to access the truth about the medications we take is through the court system. How unfair is that?
A Federal Court judge has ordered Health Canada to release reams of pharmaceutical clinical trial data on five medications to an American researcher, undercutting the federal government’s attempts to keep the information confidential.
The July 9 ruling stems from a request by Maryland-based researcher Peter Doshi for access to clinical trial data submitted to Health Canada by the manufacturers of the HPV vaccines Gardasil, Gardasil 9 and Cervarix, and the anti-viral medications Tamiflu and Relenza.
He wanted to conduct a “systematic review” of the findings, but Health Canada said it was confidential business information and it would only hand it over if he signed a confidentiality agreement.
Doshi refused and took the federal government to court.
“I hope my case sets a precedent and allows researchers, clinicians, and the public easy access to clinical trial data,” he said in an email to CBC News.
“Regulators shouldn’t have a monopoly on judging the risks and benefits of medicines or hinder others from doing the same via confidentiality agreements,” said Doshi, assistant professor at the University of Maryland School of Pharmacy and an associate editor at the BMJ (formerly known as the British Medical Journal).
Some types of HPV can lead to cervical and other cancers, and vaccines are offered to girls and many boys in Canadian schools. Health Canada says the vaccines are a safe and highly effective way of preventing the types of HPV infections that could lead to cancer.
Tamiflu and Relenza are used to treat influenza.
The court decision earlier this week is the first to interpret and apply Vanessa’s Law. The legislation came in the wake of the 2000 death of an Ontario teenager, to allow Canada’s minister of health to disclose drug information to certain people, such as those who protect or promote public health.
On Thursday, Health Canada said in a statement it is working on regulations that would publicly release the “vast majority of information in clinical trial reports” for a wide range of medications.
It said it expected the regulations would come into effect by the end of the year.
But in court, it nonetheless fought Doshi’s request, arguing it remained its practice to treat unpublished pharmaceutical company trials as confidential business information.
The ruling by Federal Court Justice Sébastien Grammond, who called Health Canada’s stance “unreasonable,” is being welcomed by experts such as Matthew Herder, director of the Health Law Institute at Dalhousie University in Halifax.
Herder has watched the case closely and said he hopes the ruling will encourage researchers, even those outside Canada, to start requesting data on other current drugs on the market.
“The court said very clearly the public interest in ensuring access to this information, so that independent researchers can scrutinize it, fundamentally outweighs any sort of interest in terms of protecting commercial interests,” he said in an interview.
“The court didn’t say a confidentiality agreement is never appropriate, it didn’t go that far, but it certainly enshrined the importance of being able to disseminate findings.”
In his ruling, Gammond said publicly disclosing clinical trial results may benefit public health and uncover biased testing, selective publishing and regulatory failures, or overturn previous conclusions on the reliability of drugs.
“Clinical trials are undertaken by researchers under contract with pharmaceutical companies. Their results are usually kept secret,” Gammond wrote. “Pharmaceutical companies have insisted that they constitute confidential business information that regulators should not make public.”
He noted that Vanessa’s Law was enacted after the 15-year-old girl’s father, Terence Young, who later became a Conservative MP, fought for stronger measures to protect the public from unintended side-effects of drugs. Vanessa died following a heart attack while taking the prescription drug Prepulsid.
Dr. Nav Persaud, a staff physician at St. Michael’s Hospital and assistant professor at the University of Toronto, said the judgment is a positive step forward.
Persaud had to sign a confidentiality agreement to get access to information on the anti-morning sickness pill Diclectin. In 2015, Health Canada threatened him with legal action if he broke the agreement.
He hopes the ruling will lead Health Canada to rethink its approach.
“I don’t view this information as confidential business information. Information about the effects of medication people are taking are not confidential,” said Persaud in an interview. “That type of information should be available to people taking the medication.
“I think it’s important because sometimes re-analyses of this data overturns conclusions. So you could go from thinking a medication is effective to not effective.
“That’s what I think happened in the case of Diclectin. But, unfortunately, because there are so many barriers to doing this type of research, it’s relatively rare that this research is done. The confidentiality agreement is one example of a barrier that regulators like Health Canada put up. And that had the effect of deterring this kind of research.”
Persaud plans to resubmit his request for information on Diclectin to Health Canada and insist that he not be asked to sign a confidentiality agreement.
The ruling added that the department’s refusal to give Doshi the data ignored his fundamental rights to freedom of speech under the Charter of Rights and Freedoms.
Had he signed the agreement, Grammond wrote, and his clinical trial concluded that the drugs were ineffective or revealed new side-effects, Doshi would not have been able to summarize or paraphrase the contents of the documents, or reproduce the company’s conclusion in a paper outlining the results of his research.
“It is difficult to understand how, in practice, Dr. Doshi could meaningfully communicate the results of his research under such constraints,” wrote Grammond.
“Health Canada … simply reiterated a policy that predated Vanessa’s Law. The objectives of that policy are unstated and unclear. As far as one can understand, they appear to contradict the purposes of Vanessa’s Law. The mere fact that the policy is aligned with the preferences of the pharmaceutical industry would be insufficient to justify a restriction on Dr. Doshi’s freedom of expression.”
UK pharma company removed work history at Purdue from Lewent’s biography
David Crow in New York 5 hours ago
A director of GlaxoSmithKline, the British pharmaceuticals company, has been sued by the state of Massachusetts for her alleged role in fuelling the US opioid addiction epidemic. Judy Lewent, who served on the board of opioid drugmaker Purdue Pharma for more than four years until 2014, was named as a defendant in a lawsuit filed by the state’s attorney-general last month. The legal action comes as US authorities step up their campaign against those they hold responsible for a crisis that resulted in 42,200 opioid overdose deaths in 2016. The litigation, described as a “ tidal wave” by experts, is designed to raise funds to cover the costs of the epidemic, including addiction treatment centres and expanded morgue capacity. The epidemic — which has been declared a “public health emergency” by Donald Trump — has attracted international attention, but GSK appears to have recently scrubbed all mention of Ms Lewent’s time on the Purdue board from its annual report and company website.
In the company’s 2016 annual report, Ms Lewent’s biography said she was “previously a non-executive director” of Purdue and an associated company until December 2014. But the 2017 report, released in March this year, omitted that reference. Screenshots from GSK’s annual report in 2016, left, and 2017: the reference (highlighted) to Ms Lewent’s connection to Purdue Pharma and associated groups was removed A similar change was made to the company’s website some time after November 2017, according to a preserved copy from The Internet Archive, a not-for profit group that maintains a library of historical webpages. A spokesperson for GSK said: “It is not appropriate for GSK to comment on legal matters faced by another company. Board biographies are updated and approved by directors during the routine annual report process. “Reference to Ms Lewent’s role as non-executive director of the private company Purdue Pharma, which ended on 31 December 2014, was disclosed in previous annual reports.”
Following the FT’s enquiries, the company said it would update its website so that Ms Lewent’s biography mentioned her tenure as a director of Purdue. Ms Lewent declined to comment via a GSK spokesperson and did not respond to direct enquiries. More than 30 US states, cities, counties and other local authorities have filed lawsuits against Purdue, a privately-held company that was among the biggest producers of opioid painkillers, as well as other drugmakers, wholesalers and pharmacy groups. Although most fatalities are caused by heroin spiked with fentanyl, a synthetic opioid, the majority of victims first became hooked on prescription painkillers like Purdue’s OxyContin before progressing to the illegal street drug.
However, the lawsuit filed in Massachusetts last month represented a new front in the legal fight because it targeted individual executives and directors of Purdue such as Ms Lewent and members of the wealthy Sackler family, which owns the company.
Ms Lewent, who is chair of GSK’s audit and risk committee, was paid $476,000 in fees by the British pharmaceutical company last year and $496,000 in 2016. A former chief financial officer at Merck & Co, the US drugmaker, she also serves as a director of Thermo Fisher Scientific and Motorola Solutions. OxyContin, made by Purdue Pharma, has been criticised for serving as a gateway to opioid addiction The legal complaint filed by Massachusetts alleges that Ms Lewent and the other defendants deceived patients and doctors on the risks of prescription opioids. It alleges that Purdue marketed the painkillers to vulnerable people, including the elderly, and encouraged physicians to prescribe them for long periods of time. Ms Lewent, who joined the Purdue board in 2009, and other directors were paid “hundreds of thousand of dollars” by the company, according to the lawsuit. The lawsuit says the directors were kept apprised of “signs that patients were being harmed” via regular reports, which “came in by the hundreds and even thousands”. Such reports were allegedly sent to Ms Lewent on eight occasions between April 2010 and July 2013.
A spokesperson for Purdue said it shared the attorney-general’s “concern about the opioid crisis”, but added: “We are disappointed, however, that in the midst of good-faith negotiations with many states, [Massachusetts] has decided to pursue a costly and protracted litigation process.” The spokesperson said the company “vigorously” denied the allegations and that it would continue to “work collaboratively with the states towards bringing meaningful solutions to address this public health challenge”. Purdue has not yet filed a response to the Massachusetts suit, but has filed motions to dismiss legal actions bought by other local authorities. One of its main lines of defence is that its medicines were approved by the US Food and Drug Administration for the treatment of chronic pain, which gave it the right to market them to doctors. “We believe it is inappropriate for [Massachusetts] to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA,” said Purdue.
When nurse Meleney Gallagher was told to line up with her colleagues on the renal ward at Sunderland Royal Hospital, for her swine flu vaccination, she had no idea the injection she was about to have had not gone through the usual testing process.
It had been rushed into circulation after the swine flu virus had swept across the globe in 2009, prompting fears thousands of people could die. From the moment the needle broke Gallagher’s skin, her life would never be the same.
“I remember vividly we were all lined up in the corridor and we were told we had to have it. It wasn’t a choice,” she claimed. “I was pressured into it. We were given no information.”
The date was 23 November 2009 and Gallagher was one of thousands of NHS staff vaccinated with Pandemrix, a vaccine made by pharmaceutical giant GlaxoSmithKline (GSK).
Eight years later, her career in the NHS is a memory and she’s living with incurable, debilitating narcolepsy and suffers from cataplexy, a sudden, uncontrollable loss of muscle tone that can cause her to collapse without warning. Because of her condition, she can no longer work or drive.
People with narcolepsy experience chronic fatigue and difficulty sleeping at night. They can have night terrors, hallucinations, and a range of mental health problems.
Gallagher is not alone. More than a dozen frontline NHS staff are among around 1,000 adults and children across Europe who are believed to have developed narcolepsy after being given Pandemrix. Today BuzzFeed News can reveal for the first time their battle to gain acknowledgement for a government decision that they say ruined their careers and has dominated their lives since.
Gallagher and four other NHS professionals – two nurses, a community midwife, and a junior doctor – have told how they felt pressured into receiving the vaccine, were given misleading information, and ultimately lost their careers.
They are all suing GlaxoSmithKline seeking compensation for what they believe was a faulty drug that has left them with lifelong consequences and means they will require medication and support for the rest of their lives.
They have been forced to take legal action, along with almost a hundred other sufferers, to force the company and the government to accept the consequences of the rushed vaccination programme eight years ago. In contrast to the UK, European countries have already compensated people whose narcolepsy was linked to the swine flu vaccine.
The revelations come the same day that health secretary Jeremy Hunt launched new measures to improve patient safety in the NHS, in response to research conducted by experts at the Universities of Sheffield, Manchester, and York that showed prescription errors cause 1,700 deaths each year, could contribute to as many as 22,000 deaths, and cost the NHS £1.6 billion.
The BuzzFeed News investigation raises serious questions over the advice that was given to NHS staff at the time by the government’s chief medical officer, the chief nurse, and the national flu director that the vaccine had been “thoroughly tested” and was safe to use. That advice was shared in a joint statement by the Department of Health (DH), medical royal colleges, and trade unions, including the British Medical Association and Unison.
Normally vaccines undergo testing to make sure they are safe, and vaccination has been proven to save millions of lives across the globe. But Pandemrix was different. It had not gone through the normal process and was fast-tracked without the usual clinical trials.
Staff were also not told that the government had agreed a unique deal with GSK to indemnify the company for any problems with the vaccine.
The investigation also turns the spotlight on decisions by the UK government to continue using the vaccine even after other European countries suspended its use once evidence of a problem emerged.
Peter Carter, then chief executive of the Royal College of Nursing, told BuzzFeed News it was “a matter of huge concern” that the vaccine had not been properly tested, contrary to what he was told at the time.
Meleney Gallagher was diagnosed in 2013 but only after years of being unable to stay awake and having cataplexy attacks several times a day, sometimes caused simply by laughing.
She switched jobs to be a district nurse, but the problems got worse. She said: “I was falling asleep in the clinic and driving home. I had cataplexy attacks when I was in the room with patients. I knew I wasn’t safe to practise.”
Although she sought help from occupational health services, her GP employer reported her to the Nursing and Midwifery Council and she was medically retired in April 2017. She received just 12 weeks’ pay for 20 years’ service in the NHS.
She said she had been denied an informed choice over the jab. “They can’t just do what they want with vaccines, otherwise it’s like Russian roulette and you can’t do that. I just want someone to stand up and to say they were wrong and apologise. Someone to be sorry for what they have done. I feel really angry.”
Gallagher’s vaccination was part of a concerted effort by the Department of Health to immunise as many workers as possible. At the time, there was widespread global concern about the spread of the swine flu virus and fears it could replicate the Spanish flu of 1918.
While the concern was to save lives, it is alleged that senior figures in the department, including the chief nurse, chief medical officer, and national flu director, did not give a full picture of the vaccine.
A swine flu leaflet produced by the DH for staff and patients ahead of the nationwide vaccination said: “The European Commission carefully considered all the evidence and recommended that [the vaccine] could be used.”
But it made no mention of the fact the European Medicines Agency had licensed Pandemrix under “exceptional circumstances” based on “mock vaccines” that did not include the actual ingredients that would eventually be injected into people. The EMA confirmed this approach was “unique to pandemic preparedness vaccines”.
The DH leaflet also made no mention of the government’s agreement to indemnify GSK for any problems with the vaccine. This was not widely known at the time, and the indemnity deal has never been published. In the summer of 2009, Wolf-Dieter Ludwig, chair of the German Medical Association’s drug commission, had warned EU governments not to bear the risk for pharmaceutical companies.
Nationwide vaccinations started in the UK on 21 October 2009, despite the fact that experts at the DH had known since May the flu was milder than first thought. On 22 October, ministers agreed to revise down the worst-case scenario from 19,000 deaths to 1,000.
Ahead of the vaccinations starting, Dame Christine Beasley, then chief nursing officer for England, told Nursing Times: “We’ve gone through exactly the same procedures as we do with seasonal flu vaccine and it’s as safe as a vaccine can be.”
On the day immunisations began, the RCN’s Peter Carter was quoted saying he was “entirely satisfied” the vaccine was safe because it had undergone “rigorous testing”.
Carter told BuzzFeed News: “At the time, Liam Donaldson, the chief medical officer, and Professor David Salisbury, the DH’s director of immunisation, were assuring people this vaccine had been thoroughly and properly tested, so people like me, in good faith, had no reason to disbelieve that and were happy to encourage people to have the swine flu vaccine.
“It is a matter of huge concern that several years later it’s now apparent this was not properly tested, and this will obviously shake the confidence of people for any future pandemic flu immunisation programmes. People have a reasonable expectation that what they are being told is accurate and it is a matter of regret that it clearly wasn’t.”
Salisbury told BuzzFeed News he believed a normal clinical trial would have been too small to pick up the problems with Pandemrix. “Given its rarity, any excess risk could only be detected after huge population exposure done through post-marketing surveillance,” he said.
He declined to comment on staff saying they felt pressured or on issues around informed consent.
Sir Liam Donaldson did not respond to a request for comment.
NHS trusts received six letters between September and October alone urging them to vaccinate staff.
In November 2009, Ian Dalton, then national director for NHS flu resilience and now chief executive of NHS Improvement, wrote for the Health Service Journal that vaccinating staff was the “highest clinical priority”. He stressed the need for staff to have information about “how it has been tested to ensure safety”.
By 4 February 2010, it was clear swine flu was not going to be the catastrophe many had feared and ministers agreed not to extend vaccinations to the public. The NHS vaccination campaign went on because staff were considered a priority group.
Dalton wrote to trusts again saying he expected improvement in the uptake rate despite the “predominantly mild illness”. In an update for the Health Service Journal, he warned against complacency and said the programme was a “key governance responsibility” for NHS boards.
By April 2010, around 40% of the NHS frontline staff had been vaccinated with Pandemrix, which was more than double the seasonal flu vaccine uptake of 17% in 2008.
Among them were Hayley Best, an intensive care nurse working in Craigavon, Northern Ireland, and Shane Keenan, a senior emergency nurse practitioner in Oxford, who worked for 35 years in the NHS.
Both said they felt pressured to have the vaccine. Keenan said he felt it was “emotional blackmail”, adding: “We weren’t informed it wasn’t properly trialled.” Best agreed: “It wasn’t that you were asked if you wanted it; you were told this was your appointment.”
Keenan told BuzzFeed News that after he got the Pandemrix jab his life “started to fall apart… By early February , I was having nightmares like you wouldn’t believe and visual hallucinations.”
Best said the effect on her was similarly dramatic, with severe suicidal thoughts within weeks.
Both said their symptoms were initially dismissed as depression and fatigue. Keenan was referred to specialists in December 2010. He struggled with work and was put through a capability assessment by his trust and moved down a pay band, decreasing his salary by £500 a month.
Eventually he realised he couldn’t continue. “I was a potential danger to patients. I went to occupational health and suggested ill health retirement.”
He said narcolepsy had “completely destroyed my life and my career. I worked damned hard to get to the pinnacle of my career. I lectured at Oxford University; now I can’t even stack shelves. I was injured in the line of duty. NHS staff are collateral damage.”
Best wasn’t diagnosed until October 2014. She switched jobs to become a district nurse but still struggled. “It really came to a head in 2014 when I started falling asleep behind the wheel of my car. I just got to the point where I would have driven to somebody’s house and not be able to remember doing it.” She was medically retired in October 2016, just before her 40th birthday.
She said: “I was given a vaccine that wasn’t properly tested. I am a big advocate for vaccination; my children have every vaccine that is offered.
“I was a good nurse, I know I was a good nurse. So where are my employers now? Where is my NHS? Where is my government? If you are going to encourage your frontline staff to have vaccines then the least you can do is have facilities in place if they happen to react to it. I feel completely betrayed. I have been abandoned. The NHS should have something in place if and when it goes wrong.”
Not everyone had been convinced the vaccine was safe for use. Switzerland’s medicine regulator Swissmedic refused to license it for use on under-18s in October 2009, and Michael Kochen, president of the German College of General Practitioners and Family Physicians, told the BMJ that same year that it had not been sufficiently tested to be declared safe.
The first hard evidence of a problem with Pandemrix emerged in 2010 when doctors in Finland noticed a dramatic increase in children with narcolepsy. Since then a number of studies in Europe and the UK have shown the vaccine is linked to an increased risk of narcolepsy in children and adults.
But even then, the Department of Health was not finished with the vaccine. While other European countries suspended its use in August 2010 due to the concerns, the UK used it to fill gaps in the seasonal flu jab supply in January 2011.
Professor Salisbury said at the time it was not a “second-class vaccine” and patients were “getting an effective vaccine and a safe vaccine”.
According to the EMA, more than 980 people across Europe have been reported as developing narcolepsy because of Pandemrix, with 872 people reported as developing cataplexy, including more than 500 children.
More than 120 children and adults are believed to have been affected in the UK – some because of vaccinations that took place in winter 2010-11, after the first studies showing the side-effects had emerged and a year after the swine flu scare.
Around 100 UK families are suing GSK claiming the vaccine was a faulty product. Their law firm, Hodge Jones & Allen, declined to comment but the case has been ongoing since October 2013. It could result in a compensation bill as high as £100 million.
In 2016, judges ruled in favour of Josh Hadfield, who received a maximum £120,000 via the Vaccine Damage Payments Act after the Department of Work and Pensions (DWP), which administers the scheme, admitted Pandemrix caused Josh’s narcolepsy when he was vaccinated aged 4.
His mother, Caroline, described the effect of the vaccine to BuzzFeed News: “He would like to have a bath on his own but he can’t because there is a risk that he is going to fall asleep and drown. He is very introverted and doesn’t like going out on his own because he is scared of what might happen.
“He sleeps two to four hours a day at school and that is when he is fully medicated. He has his own small bedroom at school. He doesn’t have a normal childhood.”
She added: “I am not saying all vaccines are bad and people shouldn’t have them. It’s the fact the government won’t help people after something goes wrong.”
During a parliamentary debate in March last year, Tracy Brabin MP accused the government of “foot dragging”, which was “causing unacceptable and upsetting suffering and distress for the families involved”.
She said in Sweden, Finland, Norway, Iceland, and France people who developed narcolepsy due to Pandemrix have already been compensated.
In 2014, 23-year-old nursery assistant Katie Clack died after jumping from a multi-storey car park. In a note to her family written on the day she died, she described the effects of narcolepsy as unbearable and urged her family to continue her legal action against GSK.
For the NHS staff who have developed narcolepsy, their ordeal has been compounded by being forced to battle with the health service and the government for recognition.
Junior doctor Ruth Tunney was in her third year of medical school on placement at Salford Royal Hospital when she volunteered for the vaccine.
“It was bundled in with the seasonal flu,” she told BuzzFeed News. “I don’t remember reading anywhere that it hadn’t been tested. I didn’t see anything that told me it was a different vaccine. It was a generic consent form.”
She added: “I appreciate at the time they thought people were going to die and they had to act. I am completely pro-vaccination but they should acknowledge what has happened and do something about it rather than just denying it, which it feels is what is happening. It’s changed my life for the worse forever.”
Community midwife Susan Hamilton was formally diagnosed in 2012 after falling asleep while driving with her son. Her career was over, and six years on she faces having to sell her family home.
Hamilton said she tried reaching a compromise with her NHS trust but “was told categorically that they could not make a job for me and didn’t have any obligation to make a job for me”.
She said: “I have been forced out of my job because of a faulty drug and a trust who would not help me work around my condition or wait until I was stabilised on my medication. The NHS has abandoned us. We are damaged goods.”
Like other staff, she said was not given information about the vaccine: “We weren’t given a choice. It wasn’t informed consent.”
In response to this winter’s severe seasonal flu there are increasing calls for NHS staff to face mandatory vaccinations. On Twitter, former NHS England and Department of Health medical director Sir Bruce Keogh responded to such calls by saying: “I think a serious debate around mandatory flu vaccination is inevitable before next winter.”
Speaking to Buzzfeed News, Keogh said: “Every winter flu puts a significant strain on the NHS and a lot of people die. Both can be reduced with sensible vaccination programmes. A debate is emerging on how best to protect both vulnerable patients and staff in the NHS, particularly since there is such a big difference in vaccination rates between NHS organisations and over a third of flu is transmitted by asymptomatic people, meaning staff could unwittingly be spreading flu to their patients. No one wants that.
“Some people are in favour of mandatory vaccination, which could be across the board or only as a prerequisite for working in certain areas. Others are opposed on the basis of freedom of choice. My sense is that staff should have their choice informed by evidence of benefit to themselves, their patients, and their organisation along with any potential personal risks or preferences.
“My view is that the focus on increasing staff vaccination rates should be on ensuring that organisations can demonstrate they have offered every single member of staff the chance to have a vaccine and made it easy for them to do so. This is what organisations with high vaccination rates do.”
On the specific issues around Pandemrix and the lack of support for the staff affected by the vaccine, Keogh said: “It would seem both fair and reasonable and in keeping with the values of the NHS that if somebody suffers as a result of trying to do the right thing for others that they would be looked after appropriately.”
Matt O’Neill, chair of Narcolepsy UK, a charity supporting some of the families affected, believes there should be a public inquiry into the use of the vaccines, what was known at the time, and how staff have been treated since.
He said: “NHS staff vaccinated with Pandemrix have been treated pretty disgustingly. Having a vaccination is an act you take on behalf of the community, for the benefit of the herd. When it goes wrong it makes sense that the herd should look after you.”
“More staff would sign up for vaccines if they saw the NHS admit when it went wrong and that it supported staff. At some point, there will be another pandemic and we will need staff to have confidence they will be looked after if something goes wrong.”
In 2010, Andy Burnham, the Labour health secretary at the time, and other ministers contributed to a review of the handling of the pandemic. It said: “[Management] personally would prefer to be criticised for doing too much rather than the alternative, where there could have been unnecessary deaths from doing too little.”
Guy Leschziner, a consultant neurologist at Guy’s and St Thomas’ Foundation Trust, has treated a number of people who developed narcolepsy after having the swine flu vaccine.
On the use of Pandemrix, he told BuzzFeed News: “It’s always easy with the benefit of hindsight. What we have to remember was what was going on at the time, which was that we thought we were going to have an epidemic of a very severe flu. Now today, knowing we didn’t have quite the epidemic we thought we were going to have, you might come to a different conclusion, but at the time we didn’t know that Pandemrix was associated with narcolepsy in comparison to the other vaccine.”
GSK refused to answer questions from BuzzFeed News but issued a statement saying further research was needed to understand what role Pandemrix played in the development of narcolepsy. The company did not renew its licence and the vaccine is no longer authorised by the EMA.
On its website, the EMA said: “Understanding the link between narcolepsy and Pandemrix remains the subject of investigations and may have implications for the future use of similar vaccines.” It said GSK had agreed to continue investigating the vaccine.
Guido Rasi, the executive director of the European Medicines Agency, said: “Immunisation has helped us to bring some major human diseases under control. Worldwide, vaccines are saving the lives of approximately 9 million people every year, more than the whole population of Austria. Today, no child in Europe has to die from formerly common childhood diseases.”
He accepted vaccines were not 100% risk-free but added: “No medicine is. There is a one in a million chance that an adverse event happens. In Europe, we are actively monitoring the safety of medicines, including vaccines, and also looking at all reported side effects. These are recorded in a database and reviewed regularly to identify any potential problem at an early stage.” Around a million reports are made every year.
The Department of Health said its decision to use the vaccine was based on evidence and advice from experts but declined to comment due to the ongoing legal action. Although the DWP has previously admitted causation in the case of Josh Hadfield, it refused to answer questions, saying it would not detail its policy on Pandemrix unless a Freedom of Information Act request was submitted.
Swine flu was a potential health crisis and there are no suggestions ministers, the DH, or GSK acted with anything other than the best of intentions to save lives. But fear of the virus and misplaced confidence in the vaccine’s safety led to staff feeling pressured to have the jab, and not being given all the facts. Eight years on, those staff are still waiting for their sacrifice to be recognised.
“It has been soul-destroying to lose my career,” said Meleney Gallagher. “I used to say if I could go to work and make one patient smile then I’d have done my job, but I couldn’t do that because I couldn’t even risk laughing with a patient in case I collapsed.
“I am angry. I put a lot into my career, I gave a lot. I would have expected a bit of respect for the effort I put into the NHS.”
“..The study looked at the average effect of anti-depressants rather than how they worked for individuals, and the researchers said the findings might not apply to use of the drugs over the longer term…”
Great documentary from the acclaimed ‘the doctor who gave up drugs’ series (see below), about the dangers of anti-depressants in kids. It has been established for a long time now that SSRI anti-depressants are unsafe for kids, but what about their use in the adult population?
Interesting segment from David Healy discussing the raw data on Seroxat in teens (see first video below). It was because of the actions of people like David Healy that Seroxat was never officially approved for use in teens in the UK. If Glaxo had gotten their way, it’s possible that Glaxo would have pushed Seroxat for a licence for kids in the UK. This would have meant more SSRI induced teen suicides.
The most interesting segment for me was the part with Andrea Cipriani, the researcher who recently analyzed a meta-analysis of studies on SSRI’s, which made waves in the media not too long ago.
Back in February, Cipriani (see second video down) said that ‘anti-depressants are effective for moderate to severe major depression in adults’. However as Dr David Healy points out, the studies that Cipriani made his analysis on, were mostly ghost written articles.
Cipriani did not study the raw data, therefore his analysis is inherently skewed. He doesn’t mention this in the many media articles he appeared in to promote this study.; he only addresses it because David Healy brought it up. It seems to me that doctors like Cipriani are merely agents of PR for psychiatry (and indeed by default then- the drug companies) than patient advocates. Every few years psychiatry needs to re-establish its dominance of the mental health paradigm.
It’s just marketing.
Why do academics like Cipriani not demand to see the raw data from the drug companies?
Why do they mislead the public?
Why does Cipriani (and indeed Carmine Pariante) not mention also that his analysis was based on very short term studies (and that these studies are not raw data studies), and that safety and effectiveness in long term use in adults has not been established? (This despite the fact that people end up on these drugs for years, sometimes decades).
I feel also that any time Carmine Pariante is interviewed on TV he should be forced to mention his links to drug companies:
His links to GSK alone are shameful considering GSK’s vast criminality and harm to consumers and patients over the decades.
“…Dr Carmine Pariante has received Funds for a member of staff and funds for research. Professor Pariante’s research on depression and inflammation is supported by: the grants ‘Persistent Fatigue Induced by Interferon alpha: A New Immunological Model for Chronic Fatigue Syndrome’ (MR/J002739/1) and ‘Immunopsychiatry: a consortium to test the opportunity for immunotherapeutics in psychiatry’ (MR/L014815/1; together with GSK), from the Medical Research Council (UK); the National Institute for HealthResearch (NIHR) Mental Health Biomedical Research Centre in Mental Health at South London and Maudsley NHS Foundati on Trust and King’s College London; by Johnson & Johnson as part of a programme of research on depression and inflammation; and by a Wellcome Trust led consortium that also include Johnson & Johnson, GSK and Lundbeck…”
I don’t trust Andrea Cipriani, I don’t think he is being honest.
I also don’t trust Carmine Pariante either, however I think he is more misguided than anything else.
Anti-depressants don’t save lives.
Doctors like David Healy save lives.
Doctors like Pariante and Cipriani help drug companies to extinguish them..
“….A senior whistleblower at GlaxoSmithKline is suing the drugs giant over claims his warnings about allegedly dangerous botched IT projects were hushed up by his superiors who eventually ended his 16-year career at the company.
Thomas Reilly worked around the world designing, installing and troubleshooting major IT projects at GSK production plants and at its UK and US data centres.
He claims he warned for years of serious issues in IT systems in many countries that caused numerous factory shutdowns.
Yet, in a lawsuit filed against the firm in the US, he says his concerns were not properly acted upon by his superiors in Britain. In one case, he says his warnings about a Latin American plant were covered up by his manager for fear of alerting auditor PricewaterhouseCoopers….“
One IT issue he warned about in 2011 in GSK’s North America Pharmaceutical arm caused a major server to become unstable, two years later causing three “crippling performance events” at factories. It was only when Reilly was despatched to fix the problem in 2013 that he discovered his original warnings had never been passed on.
“….Other major IT failures he had warned about but been ignored over covered factories in Australia, Latin America and Africa, his case alleges. Even when investigations were carried out, they were not acted upon by his manager, he claims.
When he escalated his concerns to GSK’s global compliance officer, he was told then-chief executive Sir Andrew Witty had been informed of his concerns. An investigation apparently came to nothing.
In 2015, he contacted Witty directly with his concerns that GSK’s IT systems were so fragile that they risked causing another Cidra-style crisis. Witty, he claims, sent Jason Lord, global head of corporate investigations, to the US to question him. A subsequent investigation Lord set up concluded his concerns were minor, and his employment was terminated.
The case comes as GSK awaits the outcome of a Serious Fraud Office investigation into its handling of whistleblower claims in China. British fraud investigator Peter Humphreys alleges he and his wife were jailed in China after unwittingly being hired by GSK to discredit a suspected whistleblower. He is suing GSK in the same Philadelphia court as Reilly.
Reilly’s lawyer Scott Pollins said: “We are working to vindicate Tom’s actions. We want a jury to say what he did was honourable and that he should not have been punished for it.”
Former GSK employee (turned whistle blower) Thomas Reilly’s ongoing case against GSK is perhaps the most damning (in terms of allegations against the company) that I have seen.
And that’s really saying something, considering GSK’s disturbing corporate history of seriously bad behavior!
A history that includes a 3 Billion dollar fine for fraud in 2012 (brought by whistle-blower Greg Thorpe), a 500 million dollar fine in China for bribery in 2014, an ongoing investigation by the serious fraud office UK (involving numerous other allegations), not to mention recent allegations of fraud/bribery in India (first documented on this blog before anywhere else I might add), and numerous lawsuits/controversies/scandals over the years involving harm/injury to patients/consumers of GSK drugs such as Paxil, Avandia, Myodil, Cervarix, Pandemrix, Tafenoquine, Dexedrine (all documented in 11 years blog posts on this blog).
Why do I say that Thomas Reilly’s case is possibly the most damning of all the allegations/accusations leveled against GSK for the past two decades?
I say this because these allegations shine a light on GSK’s broken manufacturing practices.
Dangerous, shoddy and broken manufacturing processes in Pharmaceuticals leads to disasters such as GSK’s infamous Cidra debacle.
In that case GSK were fined 750 million, and it was another former GSK employee- Cheryl Eckard who reported that:
“...Eckard was a quality control inspector for the company when she found trouble at Cidra in 2002. According to the CBS News coverage, Eckard found a host of mess-ups there. “All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career,” she told 60 Minutes. Tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles, she now says…”
“..Eckard reported that the Cidra plant’s water system was contaminated, that drugs were being made in unsterile conditions, and that drugs of different strengths were being mixed in the same bottle…”
Glaxo would like us to think that Cidra was a one off, however what is most disturbing about Thomas Reilly’s lawsuit against GSK is it is obvious that Cidra certainly wasn’t a one off.
Just like Glaxo’s fraud and corruption problem, GSK’s manufacturing woes are systemic.
GSK’s entire manufacturing processes are broken because the I.T. (Information technology) infrastructure-system that underpins it -is clearly not fit for purpose. The operating systems (the computers that run Glaxo’s manufacturing) are clearly defunct.
In the Cidra case, pills were contaminated, the whole factory was a mess, and medicines were put in the wrong bottles. Who knows how many deaths, or how much harm occurred to patients, from this scandal? do you think that every bottle of GSK meds from Cidra was tracked from the factory to a patient?
Of course they weren’t. It was all covered up.
I have been blogging about GSK for over a decade, and I have noticed a pattern in the media reporting of GSK’s various drug mix ups etc over the years. Even in 2005, way before Cidra was reported about, there were reports of mix ups, and drug manufacturing problems within GSK’s facilities.
See this from the Guardian in 2005:
“…GlaxoSmithKline has been forced to warn doctors in Canada that its medicine packs may include “stray tablets” for a different disease and that this could be dangerous for asthma patients.
The drug firm has had a series of quality control issues at its manufacturing plant in Cidra, Puerto Rico, culminating in the seizure of stocks of its diabetes drug Avandamet and the antidepressant Paxil by US marshals last month.
Some of the tablets were falling apart and sometimes contained the wrong dose….”
As recently as 2014 there were reports of contamination of GSK’s notorious Seroxat drug from their Irish manufacturing plant in Cork, how many people were harmed from the contaminated drugs released from the malfunctioning systems at this plant? We may never know, as once again this seemed to be covered up…
see RTE news link :
“….The Irish Medicines Board has confirmed that a number of batches of an anti-depressant drug being recalled by GlaxoSmithKline had been placed on the Irish market.
The recall was ordered following a warning from the US Food and Drug Administration.
It said the active ingredient for the drug, manufactured in Co Cork, may have been contaminated with a solvent from a pharmaceutical waste tank.
The anti-depressant is branded under the names Paxil and Seroxat, depending on the markets, and the active ingredient is called Paroxetine.
In a statement this evening, the IMB said it is also investigating the possibility that further batches of the drug were imported into Ireland from other EU countries.
The board said it is being informed by GlaxoSmithKline that the company is voluntarily recalling the affected batches at wholesale level.
It said it is monitoring this process.
It is understood that inspectors from the board are on site at the GlaxoSmithKline manufacturing plant at Currabinny in Co Cork, to ensure that the company’s investigation into what happened has been thorough.
They will also ensure that any additional work necessary is carried out and that measures have been taken to prevent a recurrence.
The IMB said on the basis of information available, there are no patient safety concerns arising from the potential contamination.
The batches of Paroxetine involved were manufactured in Cork between July 2011 and February 2012, and it is thought the medication manufactured from these batches may have already been consumed.
The US Food and Drug Administration has warned GlaxoSmithKline that unless the company addresses the deficiencies identified at its Currabinny plant it may withhold approval for any of its new products .
It said it may even ban existing Glaxo drugs manufactured there from the United States…”
A whistle-blower contacted me some years ago alleging that there was serious problems at another GSK plant in Ireland, Stiefel in Sligo. Those allegations also seemed to be hushed up too…
“….Last year I received an e-mail from a whistle-blower based at the GSK (Stiefel) site who claimed that there was a major contamination problem at this GSK site in Sligo in Ireland. Allegedly, there was asbestos contamination which affected a few GSK drugs that are manufactured there (and also according to these claims- if they are true- some employees health has been affected by these health and safety breaches)…”
Even as recently as just this year (2018), there were media reports of a Glaxo recall of Ventolin inhalers from a GSK factory, this time from one of the French manufacturing sites:
“….GlaxoSmithKline is again having issues with the manufacturing of some of its respiratory inhalers, leading it to voluntarily recall some products in the U.K. and eight other markets, but not in the U.S….”
The issue, which occurred during the assembly of the devices, involved a foil strip containing the medicine inside the device which may have been damaged, reducing the full number of doses the inhaler may deliver. The issue, which affected one day of production or about 200,000 units, has been fixed, he said. The inhalers were assembled in June of last year at GSK’s site in Evreux, France…”
Interestingly in 2015/2016 , a similar breach occurred.
This breach involved :
“…GlaxoSmithKline voluntary recall of two lots of Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations…”
Furthermore in 2017, a massive breach occurred, and this time the source of the defective GSK product came from its plant in Zebulon, North Carolina.
“….The company said it had received an elevated number of product complaints about a bulging of the outside wrapper, indicating a leak of the propellant that delivers the medicine. The recall involves three lots of the Ventolin HFA 200D inhalers manufactured at GSK’s plant in Zebulon, North Carolina.
The U.S. Food and Drug Administration has approved the voluntary “Level 2” recall, which only affects products in the United States, GSK spokesman Juan Carlos Molina said.
The defect does not pose a danger to patients, so they are not being asked to return inhalers they have already purchased.
GSK said it was trying to identify the root cause of the problem and would take corrective action.
Meanwhile, the Zebulon plant is still making the inhalers, Molina said….”
“We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK said in a statement.
As recently as February of this year (2018), GSK recalled some more of its inhalers due to problems and defects in their production and manufacturing:
“…GSK is recalling two specific batches of Ventolin (salbutamol) 200mcg Accuhaler devices from patients and one specific batch of Seretide (salmeterol xinafoate, fluticasone propionate) 50/250mcg Accuhaler devices from hospitals, pharmacies, dispensing practices, retailers and wholesalers….”
This action follows a manufacturing issue that may result in a small number of Accuhaler devices not delivering the full number of doses in the device.
The Accuhaler, which has a distinctive disk-like shape, is used to treat asthma, but is not widely used in the UK compared to the more commonly used Evohaler.
Dr Karen Mullen, UK Medical Director, GSK, said: “It is very easy to check whether a Ventolin Accuhaler device has come from an affected batch by checking the Lot number. Any patient who has an affected inhaler should return their inhalers to their pharmacist or dispensing practice where they will be issued with a replacement inhaler. This isn’t something we want patients to be alarmed about but it is important that we ensure our inhalers work properly for all our patients. We are committed to supplying high-quality products to our patients and sincerely regret any concern caused to them and healthcare professionals.”
“..The MHRA – the body that regulates the devices – warned that patients may find their symptoms are not relieved as normal…
In 2014, Glaxo ordered a recall of its dodgy Alli (weight loss) pill :
“…GlaxoSmithKline (GSK) Consumer Healthcare has voluntarily recalled all of its nonprescription weight-loss drug orlistat (alli) from retailers in the United States and Puerto Rico, the company announced March 27.
GSK said customers have reported that bottles of orlistat they purchased over the counter in retail stores contained tablets and capsules that were not orlistat…”
In 2016, GSK recalled its antibiotic Bactroban due to contamination.
Bactroban is a skin cream, therefore, people would have rubbed this contaminated product into their bodies- who knows what harm that did?
“…GlaxoSmithKline announced a recall of 13 lots of Bactroban (mupirocin) Nasal Ointment, Bactroban Ointment, and Bactroban Cream. This recall is a precautionary measure due to potential contamination during manufacturing….”
A similar Bactroban recall was issued in 2015:
“…31 August 2015
GSK Australia, in consultation with the Therapeutic Goods Administration (TGA), is initiating a pharmacy level recall of five batches of Bactroban Cream and three batches of Bactroban Nasal Ointment.
GSK is undertaking this recall due to the potential for physical particulate (sub-visible) contamination of the Active Pharmaceutical Ingredient (API) used in the manufacture of Bactroban Cream and Bactroban Nasal Ointment…”
GSK’s toothpaste product was also recalled due to possible foreign substances in it, notably – metal. Imagine brushing your teeth with contaminated toothpaste..
“…USAF Dental Evaluation & Consultation ServiceRecall: Parodontax Whitening (Stannous Fluoride) Daily Fluoride & AntigingivitisToothpaste—Possibility of the Presence of Metal in the ProductGlaxoSmithKline issueda Recall on Parodo ntax TP Whitening 3.4 ozGSK, due to presence of foreign substance: possibility of the presence of metal in the product. Identify any affected product in inventory and contact the manufacturer.GlaxoSmithKline manufacturer letter was not provided..”
“….With its deal last year to combine consumer health operations with Novartis ($NVS) in a joint venture that GlaxoSmithKline ($GSK) will run, GSK CEO Andrew Witty bet a big piece of the drugmaker’s future on products like OTC pain meds and toothpaste. While Witty has lauded the future of that operation, it has stumbled in that market with the recall of nearly 4 million tubes of toothpaste products that may give users splinters.
GSK is recalling dozens of lots–3,977,252 tubes–made up of different varieties of Biotene and Sensodyne toothpaste, from the U.S., Puerto Rico and Taiwan. According to the FDA’s most recent Enforcement Report, “fragments of wood were found when the product was extruded onto a toothbrush.” The toothpaste was actually manufactured for GSK by Oratech, a Utah-based contractor.
According to a letter to retailers posted by Smith Drugs, GSK started the recall several weeks ago but the product has been on the market for nearly two years. It was shipped from June 2013 through April of this year. GSK said it was alerted to the problem by a “small number of complaints.” In a statement today, GSK said only that it hasn’t learned of any injuries from the tainted toothpaste but is recalling the product as a precautionary measure since they may contain wood fragments….”
In 2011, there was a recall issued for 3 GSK vaccines- Synflorix, Infanrix and Fluarix because of suspected quality defects:
“….The Department of Health (DH) today (March 4) ordered a licensed drug company, GlaxoSmithKline Ltd. (GSK), to recall from the market 144 units of three of its vaccines because of suspected quality defect.
The products to be recalled are 115 units of Fluarix vaccine (Registration No.: HK-43003; Batch No.: AFLUA510AB) from eight private practitioners and two units from Hong Kong Baptist Hospital (HKBH); 20 units of Infanrix-IPV/Hib vaccine (Registration No.: HK-47367; Batch No. A20CA598A) from Hong Kong Sanatorium and Hospital Ltd (HKSH); and two units of Synflorix vaccine (Registration No.: HK-58098; Batch No. ASPNA023DC ) from DH’s Anne Black Maternal and Child Health Centre (MCHC) and five units from Ap Lei Chau MCHC….”
In 2011, Hong Kong considered prosecuting GSK over issues with its antibiotic Augmentin:
“…Hong Kong isn’t happy with GlaxoSmithKline ($GSK). Regulators there have ordered the drugmaker to recall an antibiotic roughly a month after they found powdered forms of the drug contaminated by chemicals known as “plasticizers.” The new recall order applies to Augmentin tablets, which also were found to be tainted by the chemicals....”
In 2014 GSK had other manufacturing issues with its nicotine product:
“…26 March 2014
GSK is in the process of voluntarily recalling from warehouses and distributors a number of batches of nicotine lozenges sold globally, after we detected manufacturing issues affecting some batches. In some cases, the lozenges were larger or smaller than GSK’s manufacturing standards….”
In 2015, GSK recalled its Maxinutrition product over choking concerns:
“…GlaxoSmithKline (GSK) is recalling all batches of MaxiNutrition Cyclone Milk (strawberry flavour and chocolate flavour). In some cases one of the ingredients, creatine, has recrystallised in the product and if consumed may cause choking and injury to the mouth. A point of sale recall notice should be displayed in stores that sold this product….”
In 2013, GSK issued a warning about defects in its Childrens Panadol Baby Drops, which could lead to accidental overdose in babies…
“Recall – incorrectly placed dosing indicator 26 November 2013 …This update provides further specific information about the recall of Children’s Panado Baby Drops being undertaken by GlaxoSmithKline (GSK), in conjunction with the TGA, for a misaligned dosing syringe that could lead to accidental overdoses.
In 2011, GSK recalled some of its Lucozade products, in some there was a risk of mould:
A Similar recall occurred in 2009:
“...The Centre for Food Safety warned the public not to drink two types of Lucozade Sport Drinks after mould was found in the products. The drinks concerned are Lucozade Sport HydroActive (Citrus Fruits Flavour Drink) and Lucozade Sport HydroActive (Summer Fruits Flavour Drink), both made by GlaxoSmithKline (GSK). The company was recalling the products and had set up a hotline, 6015 6889, for customers….”
In 2010, GSK recalled its Warfarin tablets in NewZealand:
GlaxoSmithKline New Zealand Ltd (GSK) is recalling all Marevan (Warfarin) 3mg tablets dispensed to patients since 23 November 2009. Marevan (Warfarin) is an anticoagulant treatment used to prevent blood clots. Marevan 3mg tablets are blue in colour.
The recall of Marevan (Warfarin) 3mg tablets is due to a manufacturing problem with some tablets dispensed after 23 November 2009. The problem could result in some tablets containing a higher dose of Warfarin than intended.
If tablets with a higher dose of Warfarin are taken, patients may be more likely to experience an adverse reaction to the medicine such as abnormal bleeding or bruising, vomiting with the appearance of coffee grounds or blood, blood in the urine or stool, black tarry stools…”
In 2012, Glaxo recalled 394,000 bottles of a hypertension drug due to bottle mix ups:
“….GlaxoSmithKline PLC (GSK) has recalled more than 394,200 bottles of a drug used in the treatment for high-blood pressure due to the potential for tablet mix-ups at a plant that supplies the drug. U.K-based Glaxo said on Friday last that it had issued a voluntary recall of all bottles of DynaCirc remaining in the U.S market from wholesalers, pharmacies and hospitals…..”
In 2015, Glaxo withdrew its flu drug due to ‘potency’ issues:
It seems this vaccine came from a Canadian plant with manufacturing issues:
GlaxoSmithKline (GSK) is recalling all remaining FluLaval Quadrivalent Thimerosal-Free prefilled vaccine syringes because they may offer suboptimal protection against some influenza strains, according to a company statement.
“As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine,” the company statement notes. “The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern.”
In 2017, GSK announced a recall for a Meningitus Vaccine due to:
“…This recall is considered precautionary as the batch associated with the recall was subject to a “mechanical intervention executed during the aseptic filling operations, which is not supported by validation data.”
In 2014, GSK recalled batches of Eye-Mo for non-compliance with standards:
“…GSK recalls batches of Eye-Mo for ‘noncompliance’ with standards
Pharmaceutical firm GlaxoSmithKline is recalling several batches of its Eye-Mo Red Eyes Formula Ophthalmic Solution, the Food and Drug Administration said over the weekend.
The FDA, in Advisory 2014-066, said the recall covers batches of Tetrahydrozoline HCl 0.05% Ophthalmic Solution with registration number DRHR-431.
It said this stemmed from the noncompliance with good manufacturing practice issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci, the maker of Tetrahydrozoline HCl.
“The active pharmaceutical ingredient Tetrahydrozoline HCl was used in the manufacture of Eye-Mo Red Eyes Formula Ophthalmic Solution by GlaxoSmithKline (Tianjin) Co. Ltd. China,” it said…”
Glaxo packaging defects from 2014:
“…GlaxoSmithKline has voluntarily recalled four lots of Panadol Advance 100-count bottles in Puerto Rico. The recall for the pain relief medication was issued due to a lack of appropriate child-resistant packaging to protect against access by young children. Panadol Advance contains acetaminophen, which is required to be noted clearly on the label and given special packaging to avoid acetaminophen overdose or poisoning….”
In 2016, Glaxo was warned about contamination at its Penicillin Plant:
“…GlaxoSmithKline is recalling a “small” number of batches of its Bactroban antibiotic following a harsh rebuke from US regulators about contamination at a key plant. The move comes after the US Food and Drug Administration sent a stern warning letter late last month to the drug maker about a host of quality-control problems at the facility, which is located in Worthing in the United Kingdom.
The FDA issued its missive as a follow-up to a July 2015 inspection of the facility and found what it called “significant deviations” from good manufacturing practices, according to the June 30 letter, which was posted on the agency web site yesterday. The FDA, moreover, also noted that the drug maker provided an inadequate response, despite having halted production of the antibiotic and recalling product from wholesalers last year…”
Imitrex recall from 2013 :
“…GlaxoSmithKline has issued a voluntary recall for two lots of the migraine medication Imitrex (sumatriptan). Pre-filled syringes in the affected lots (C637078 and C632842) may be protruding through the protective packaging, affecting sterility of the product and putting patients at risk for potential infection…”
Glaxo Recalls then discontinues Polygrip under mounting pressure from lawsuits:
“:…Facing increasing pressure from zinc poisoning lawsuits and critics calling for a Super Poligrip recall, GlaxoSmithKline has announced that it will discontinue all Super Poligrip denture adhesives that contain zinc….”
2011, Problems with Glaxo’s Lamotrigine:
“…Two batches of Lamictal 200mg have been recalled by manufacturer GlaxoSmithKline after tablets were found to have delayed dissolution.
Glaxo recalls batched of blood pressure drug in 2012:
“….GlaxoSmithKline ($GSK) is the latest victim of a contract-manufacturing snafu. The company has recalled 394,230 bottles of its DynaCirc CR blood pressure drug over fears that other tablets made at the same plant might have been mixed into the packages...”
Glaxo recalls ‘wrongly labeled’ Athlete’s foot drug in 2016:
“…GlaxoSmithKline’s consumer unit is recalling 462,732 bottles of Zeasorb AF miconazole nitrate 2% that it manufactured for its North Carolina-based Stiefel Laboratories. According to the FDA Enforcement report, some of the labels have incorrect NDC codes while some back labels incorrectly state “use for the cure of most jock itch” rather than “use for the cure of most athlete’s foot.”…”
In 2012, Glaxo recalls baby vaccine over fears of bacteria contamination:
“….Islamabad – Ministry of National Health Services (NHS) on Tuesday directed for recall of a cough syrup named ‘Sancos’ from all pharmacies of the city on the ground that it carries more percentage of pseudoephedrine than the prescribed share, said an official on Tuesday.
The letter said that both Novartis and GSK had deliberately hidden information for several months and allowed consumption of the sub standard drug. In July 2017, they were about the failure of batches, but initiated action in January 2018....”
“…The letter further said that it is a matter of concern that the integrity of the data on which drug is marketed is questionable..”
In 2015, GSK closed its North Carolina plant because of contamination problems:
“…Aug 11 (Reuters) – Drugmaker GlaxoSmithKline closed its North Carolina factory on Tuesday after testing at a cooling tower found bacteria that causes deadly Legionnaire’s disease, a company spokeswoman said.
The Legionella bacteria was discovered during routine inspections at the site in Zebulon, N.C., GSK spokeswoman Jenni Brewer Ligday said….”
2017: Woman sues GSK for wrong dosage cock up-
“…A 26-year old student is reportedly suing UK pharmaceutical giant GlaxoSmithKline (GSK) after claiming she received the wrong dosage of a medication that caused her skin to burn off.
Khaliah Shaw, a graduate student at Georgia College and State University in the US, was prescribed an anti-seizure medication lamotrigine, marketed as Lamictal in the US in 2014, according to a report by 11Alive, an NBC-affiliated TV station in Atlanta….”
In 2010 GSK’s Rotarix vaccine is recalled due to Pig Virus contamination:
“…Contamination has led to a temporary halt in the use of a childhood vaccine and to a separate drug recall expansion.
GlaxoSmithKline’s oral rotavirus vaccine Rotarix has been temporarily shelved in the U.S. due to a pig-virus contamination. Researchers stumbled on DNA from porcine circovirus type 1–believed nonthreatening to humans–while using new molecular detection techniques. More work is being done to determine whether the whole virus or just DNA pieces are present…:”
2009 – GSK recalls H1N1 Vaccine because of ‘something wrong with the batch”
“…More than 100,000 doses of the H1N1 vaccine are being withdrawn across the country, after Manitoba health officials announced Thursday they’d noticed a higher-than-usual number of allergic reactions from one batch.
Vaccine manufacturer GlaxoSmithKline has asked several provinces to set aside the 170,000 doses from the questionable batch.
GSK say the batch recall is a precaution an they will investigate to see whether there is something wrong with the batch….”
GSK accidentally dumps Polio virus into a river in 2014:
“..September is proving to be another tricky month for GlaxoSmithKline’s ($GSK) vaccine production operation. Having begun the month by revealing new problems at its Canadian flu vaccine plant and followed that up with a fine for violating the U.S. Clean Air Act last week, GSK has now accidentally dumped live poliovirus into the Belgian sewer system…”
GSK has mysterious ‘manufacturing issues’ with a chicken pox vaccine in 2014 :
GSK has more manufacturing problems in its Italian plant in 2016
“…Manufacturing Problems at Plant Disrupts Production of Some GlaxoSmithKline Drugs
Published: Jun 17, 2016Manufacturing problems at a factory in Italy have disrupted production of some GlaxoSmithKline medicines, leading to shortages of a commonly used opioid anaesthetic in Denmark.
The British drugmaker said on Friday it had temporarily suspended manufacturing at its Parma site, which makes sterile products, to investigate environmental monitoring, adding this was unrelated to risks from any medicines.
The factory has now recommenced manufacturing….”
GSK has more manufacturing problems in its Quebec factory in 2014:
“…TORONTO – The company that makes about half of Canada’s seasonal flu vaccine order and has the country’s pandemic flu vaccine contract has been issued a warning from the U.S. Food and Drug Administration over problems with bacterial contamination in its Quebec manufacturing facility…”
2016 – GSK recalls Avandia due to due ‘to a tablet dissolution quality issue‘
2010: Glaxo recalls Emo-Cort due to ‘mould contamination”
“…Emo-Cort lotion recalled
GlaxoSmithKline has started to voluntarily recall lot number 5R6 of their product Emo-Cort 2.5% Lotion from the Canadian market. The company is asking wholesalers, pharmacies and hospitals to immediately stop selling the lot.
The recall follows a consumer complaint to the company regarding a brown substance in the product. Testing by GSK showed mould contamination.
“There is a potential risk of local or more widespread infection from the mould contamination in those Canadians with weakened immune systems,” the regulator said….”
I can only imagine the devastating trauma that GSK inflicted on Peter Humphrey when they set him up as the fall guy for their despicable crimes in China. It seems that wherever GSK go- destruction, pain and misery follows..
‘I was locked inside a steel cage’: Peter Humphrey on his life inside a Chinese prison In his first written account of the ordeal, the former corporate investigator looks back on 23 harrowing months in Chinese jail Share on Twitter (opens new window) Share on Facebook (opens new window) Share on LinkedIn (opens new window) Save to myFT Peter Humphrey February 16, 2018 Print this page Introduction In January 2013 the Anglo-American pharmaceutical giant GlaxoSmithKline received an anonymous email alleging widespread bribery of doctors and hospitals by its China operation. Two months later, it also received a secretly filmed sex tape featuring GSK’s China chief Mark Reilly. The company hired ChinaWhys, a risk-advisory firm based in Shanghai, to investigate Vivian Shi, its former head of government affairs, suspecting her at that time of a smear campaign. ChinaWhys was run by Briton Peter Humphrey, a former journalist who had previously led China investigations for US risk consultancy Kroll and the accounting firm PwC, and his Chinese-born American wife Yu Yingzeng.
Both were certified fraud investigators. In June 2013, the Chinese government announced a bribery investigation into GSK China. In July, Humphrey and Yu were detained and charged with “illegally acquiring personal information” of Chinese nationals. The story received huge attention internationally and, in August 2013, the couple were paraded on state TV, purportedly confessing. In a note dictated from prison in March 2014 and seen by the FT, Humphrey accused GSK of having failed to fully disclose the corruption allegations against the company when he agreed to work for them. In August 2014, he and Yu finally stood trial and were convicted and sentenced to 30 and 24 months in jail respectively.
In a separate trial in September 2014, GSK China was found guilty of bribery and paid a fine of £297m, upon which its detained executives were released. Humphrey was released from prison under diplomatic pressure in June 2015 amid reports of ill health, and he and Yu left the country. This is his first personal account of the 23 months they spent in captivity. I sat on the rough wooden floorboards of a spartan cell in the Shanghai Detention Centre, reading an old copy of FT Weekend that had been brought in by my consul, and shivering as winter approached. It’s not the kind of spot the FT imagines its readers in. But in 2013, this floor — shared by 12 prisoners — was my breakfast, lunch and dinner table. I was reading an interview with Russia’s most famous convict, oligarch Mikhail Khodorkovsky, who was stuck inside a frigid Siberian jail.
It was a powerful article, which aroused comparisons to my own ordeal and spurred me to read more widely about captivity. During the 23 months I spent imprisoned in China, on false charges that were never proven in court, I consumed about 140 books, including jailbird classics such as Dostoyevsky’s Crime and Punishment, Dumas’ Man in the Iron Mask, Solzhenitsyn’s One Day in the Life of Ivan Denisovich, and modern equivalents such as Marina Nemat’s Prisoner of Tehran. Mental fodder to help me endure my own predicament.
This “detention centre” was once one of China’s notorious — and supposedly now abolished — “education through labour” prisons for miscreants in the Communist party-ruled dictatorship. Today, they pretend to be custody centres but they are still punishment centres. Untried prisoners are condemned from day one, starting with the dire conditions they face when they arrive. The aim is to isolate, crush the spirit, break the will. Many crumble quickly. My journey here began at the offices of my corporate investigation company in Shanghai on July 10 2013. I had living quarters there with my wife, Ying, and we were getting ready for our day. At 7am the Public Security Bureau (PSB) police flooded in, kicking our bedroom door into my face and injuring my neck. From that moment on, things moved ruthlessly fast: they ransacked the office, dismissed my staff, separated my wife and me from each other, and both of us from our teenage son Harvey. It would be two years before we were reunited.
Men in plain clothes drove us in unmarked black cars into the bowels of a hulking concrete building known as “803”, a feared headquarters of the Shanghai PSB. I was taken along underground corridors lined by dank interrogation cells, and through the gaps in doors saw prisoners slumped in metal chairs. When we reached my room, I sat in an interrogation chair with a lockable crossbar. PSB men came and went, asking questions about items found on our laptops. On a podium my confiscated mobile phone rang relentlessly but our son’s frantic calls to us went unanswered. Peter Humphrey: my time in a Chinese prison “Where did you get this?” “Where did you get that?” The interrogators’ questions were targeted. They knew what they wanted. As a business specialising in investigative work, we used code names. “Who’s this agent? And his phone number?” Fifteen hours later, we sped out of the building in the dead of night. Ying and I were again in separate black cars. There was no word on where we were going. As we rode into a slum off the Hunan Road, a PSB man handcuffed me, saying, “I’m sorry, I don’t think you deserve this but I have orders from above.”
Prisoners were always delivered at night. It made them weaker, easier to break We halted in a dark alley before a towering gatehouse with one-foot-thick iron doors rolling into the walls on either side. The gates were guarded by paramilitaries of the People’s Armed Police (PAP). Other PAP men patrolled the two-metre-thick perimeter walls. In a “check-in” area, our pockets were emptied. I had to take off my jacket, shirt, slacks and Pierre Cardin shoes, and was photographed against a wall, front and side on. In the cell block, a warder made me strip to check I wasn’t hiding anything — anywhere. He threw me some cotton shoes half my size and a smelly red vest with a “V” torn into its neck, and “Shanghai Detention Centre” stamped on its back. At about 3am I was tossed into a sweltering cell. It was, I learnt, a ritual — new prisoners were always delivered at night. It reinforced the shock. Made them weaker. Easier to break, to extract confessions from. The warder shut the door with a clang and uncuffed me through the bars. “What’s up?” mumbled a sleepy voice in Chinese from under a mound of pink bedclothes. “A new guy,” said another. A man in boxer shorts came to the door. “Sleep there,” he said, dumping a dirty quilt on a narrow spot beside the toilet. My head was bursting hot. Stunned and exhausted, I wept. Around the cell, shaved heads popped up like chicks from a nest to glimpse the commotion, then went back to sleep nonchalantly. A dozen or so bodies lay in rows on the rough boards, like sardines in cans with pink lids. A ceiling light burned brightly — in fact, it was never off. I felt winded. How could I sleep? Then suddenly it was light outside too. It must have crept up slowly but the new day came as a shock. My horror movie rolled to the next scene.
A low-pitched horn broke the silence. I hear it every day still. Bodies sat up. Warders on the corridor in pale-blue shirts banged on the bars. “Qilai, qilai.” “Get up!” At breakfast the gritty rice and the briny smell of pickle made me retch. Some men had sachets of “cereal” powder that they mixed with boiled water from an urn perched outside the bars. “Have one of my cereals,” said one inmate. Two men cleared the dishes and took them to the sink. Their actions were chores rostered to each detainee by the warder. Cleaning the floor, washing the dishes, scrubbing the toilet, stacking the boxes and quilts, emptying the urn twice a day for refilling, washing and folding the cloths. These jobs rotated each week. The men exercised by circling the cell for 10 minutes like Tibetan pilgrims at a temple, minus the Buddhist chants. But this was no temple, just a floor five by three metres. The entrance and toilet added another two square metres. The toilet was a hole in the floor with a rusty flushing lever on the wall behind it. The sink was a heavy, cracked ceramic affair with a cold tap. Above it was a piece of shiny plastic, supposedly a mirror, warped so you couldn’t see a clear image. During 14 months here, I did not see my own face. After the “stroll” came the toilet ritual
. Orange vests sat on designated spots beside the wall. Red vests — new boys — faced the grille studying a brown rule book. We went to the toilet in turns, red vests last. Squatting over the hole I almost toppled as I reached for the flusher behind me. “To shit, face forward; to piss, face the wall,” barked Li, the cell boss. “That way, it falls the right way without a mess. You did it the wrong way.” Over the next 10 days, like a dog yapping at my ankles, Li ordered me to do this and do that. To learn the rules. Some of the men were kind; not all. On day 10, the warder ordered me to gather my things. “You are going home,” said Li. The other men echoed his pronouncement and told me to put on proper clothes and dump my red vest. My heart rose. When the warder fetched me, he barked at Li, who had cruelly conned me — I was only moving cell. My heart sank. They moved me to Cell 203 and gave me an orange vest. My new boss was Liu, 34, sentenced to 13 years for illegally owning guns to shoot rabbits. “Most people here committed crimes for money,” said Liu. “But I am only here because of my hobby.”
There were three Chinese in their late fifties like me, in the green vests worn by inmates with chronic illnesses. All three were wealthy businessmen, hostile to the political system. All were awaiting trial, accused of fraud; all claimed to have been framed. The cell was nicknamed “sick men’s cell” by the others; I called it “the billionaires’ cell”. The aim is to crush the spirit, break the will. Many prisoners crumble quickly Whatever the cell, the rituals were the same. During exercises, which were aired on a closed circuit overhead TV, we imitated jumps and stretches performed by three PE coaches, one male, two female — the closest my cellmates ever got to a woman. Then a white-coated patrol doctor came by our grille. Inmates raised health issues but they would be lucky to get a dollop of ointment for a sore foot, or an aspirin. Next came “study time”. We sat cross-legged on red spots on the floor while the TV relayed “lessons” from the detention centre “propaganda department”. Sometimes it was the “propaganda director” preaching about good behaviour and analysing recent statistics: how many detainees had quarrelled or fought; how many inmates had argued with the guards or broken other rules, and been punished by isolation or prolonged squatting. Inmates sat quietly. Some would try sneak-reading a book. Others plotted how to handle their case, or dreamed. Nobody took “study” seriously, though sometimes we had to write a commentary on the session. That was our life. A waiting game. No family visits. No letters home. Just brief messages to lawyers. No chance to orchestrate a real defence. Foreign prisoners could receive consular visits, to the envy of Chinese cellmates Usha, the vice-consul who visited me regularly, and her assistant Susie, relayed messages to and from my family, brought books and magazines, and lobbied over my health.
They were my angels. In the detention centre I developed symptoms of prostate cancer, a long hernia, skin rashes, anal infections and constant diarrhoea, and endured an injury to my spine inflicted during the raid. None was treated. There were frequent interrogations. For these I was locked in an iron chair inside a steel cage facing a podium where three PSB men questioned me and, once or twice, men from “a different department”. Most of it was smoke. I had to thumb-print statements in red seal ink, and specimen documents from my project files. The PSB men did not want to hear any mitigating explanations. They tried to make it look as though Ying and I earned millions from trading in data, which we never did. Twice, the “other department” men tried to stitch me up for spying. They tried to accuse me of spying in the restive Muslim region of Xinjiang.
They tried to tie me to a US intelligence entity spying on North Korea. © David Foldvari After seven months, Ying and I were finally allowed to exchange jailbird love letters. They took a month to travel 30 metres through the concrete and three layers of police censorship. We were not allowed to discuss our case. Some of our letters were blocked without telling us. But I reminded myself that the Chinese men had no such privilege. After 13 months without trial, I finally went to court on August 8 2014, where Ying and I were charged with “illegally acquiring citizens’ information” (which we denied). That day also saw one of the most deeply distressing moments of the entire ordeal. The police had told me shortly before our trial that Ying had been informed of the recent death of her brother, Bernard. So, on the morning of our trial, when I saw her on the stairs in the courthouse, I expressed my condolences. The manner in which she broke down told me instantly that they had lied. She didn’t know. I believe they did this on purpose to destabilise us for the trial. We were predictably sent down, me for 30 months and Ying for 24. From the moon, Qingpu Prison would look like a peaceful walled university campus with dorms, gardens, camphor trees, a soccer pitch and a parade ground. From my level, there were a dozen concrete cell blocks with barred windows, a prison theatre, an office block, a kitchen, a boiler house and a factory.
The perimeter wall bristled with razor wire and was patrolled by armed PAP guards. It could hold 5,000-6,000 prisoners. It also “trained” prisoners for redistribution to other prisons. Cell block eight was for foreign men, the adjacent block for Chinese. A tall iron fence sealed off a yard between the block’s wings. A bald middle-aged Malaysian lifer came to the gate and helped carry my prison bags. His nickname was MC. He was block eight’s “king rat”. He ran a Malaysian mafia that controlled all the food and job assignments at Qingpu. “What are your thoughts?” a bespectacled senior officer asked me when I arrived. “I don’t know what you mean,” I replied. “What will you do here?” he asked. I did not realise his questions were euphemisms for, “Will you write the acknowledgment of guilt and ‘repentance report’?” that was required of all prisoners. “I can teach some English to your staff,” I said innocently. I was led to the “training cell” for new prisoners, and given blue-and-white-striped shorts and a white short-sleeved shirt with blue tabs, the summer prison uniform. I became prisoner number #42816. There were frequent interrogations. I was locked in an iron chair inside a steel cage My cell held 12 prisoners. We slept on iron bunks with wooden planks and a cotton “mattress” one-and-a-half inches thick, covered with a coarse striped sheet. The barred windows were never closed. Winter was freezing. “I am the cell leader,” said a wiry young African, one of many Nigerians there, most convicted of drug smuggling and serving life terms.
We were joined by two Chinese prisoners who held foreign citizenship: Zhang, an Austrian citizen serving a long term for people-trafficking; and Chen, a Thai citizen who was in jail for embezzlement. They were snitches who informed against everybody and who had been moved into the cell to monitor me. As both spoke some English, they would follow me everywhere, listen to any conversations I had and report back to the officers. Zhang managed the cell block’s factory production; Chen worked as “social secretary” between prisoners and officers. “How do sentence reductions work? How does the points system work?” I asked. “We don’t know, you must ask the captains,” they lied. “At least, if you want to qualify for reduction, you must confess.” © David Foldvari I spoke next to a Captain Liu. “What are your thoughts?” he said in broken English in a small interview room with bars separating us. My first thought was, “Here we go again.” “I am innocent and I will not admit any crime,” I said. “If I have to stay here, I will use my time to read. I can help teach people English if you want me to. I want to know about the sentence-reduction system.” Liu seemed awkward dealing with a grey-haired Englishman about his own age. “Studying is a privilege, not a right. You should write confession and repentance reports,” he said.
He was more civilised than most warders and I think he genuinely hoped to have a good rapport with me. I disappointed him. “I will not write any of that,” I said. “And I demand medical treatment for my ailments, including my prostate.” Zhang led me back to the cell. In the corridors and stairs other prisoners appeared. They smiled and nodded at me. On our corridor an African inmate tried to chat. “They told us all not to talk to you,” he said. “They said you are an MI6 spy. None of us believes it. We saw your trial on TV. We have been waiting for you. You are a hero. If you need anything, tell us, we will help you,” he said, ignoring Zhang and Chen, who fluttered and clucked like anxious hens. I had brought no toiletries, having been told I would get new ones. Instead, I had to buy them and I had no prison account, even though my warders handed over the money from my detention centre account to the prison. Initially, the officers also banned me from sending letters to family, making phone calls or using the prison shopping system. But I soon found a pile of things on my bunk — tissues, laundry powder, biscuits, coffee sachets, a small towel, two plastic rice bowls, pens and notepaper.
Inmates dropped these things there as anonymous charity donations. Zhang and Chen led me to my first supper in the “workroom”, where some 120 prisoners occupied rows of tables with backless, immovable seats attached. As I walked in, all eyes were on me, along with those of six officers. The food was warm here, sometimes hot. A standard dinner was a bowl of steamed rice, almost grit-free, stir-fry including a meat and a vegetable, and a thin soup. The Ritz! MC’s gang served one cell at a time, ladling food from battered trays. Peter Humphrey with his wife Ying at their Surrey home, 2017 After a final roll-call at 9pm, the barred cell door was locked and trusted prisoners from a Chinese block stood watch on the corridor to report nefarious activity or suicide bids. The ceiling light was kept on all night. We awoke at 6am. One of us cleaned the toilet area before the others rose. A warder unlocked the cell and the men trooped down to the yard with Thermoses to collect boiled water for hot drinks or washing. Two flasks per man. For breakfast we ate plain rice congee or a steamed bun with salt pickles, and, every Sunday, a boiled egg. There was half-an-hour of exercise in the open air before breakfast in a yard the size of a basketball pitch. After a few days, nice Captain Liu vanished and word flew round that young Captain Wei would manage our cell. Wei was notorious for persecuting inmates and stirring up incidents that led prisoners to get a beating and to be dragged off screaming to solitary, which I witnessed over and over again. “They are sending him here because of you,” I was told.
Indeed, Wei summoned me several times a week for a “talk”. He tried to provoke my anger, insulted me, ordered me to write confessions, threatened me with an extended sentence or solitary if I refused. I never yielded. Every week I cited my medical problems and demanded proper examinations and treatment for my prostate. “But you haven’t confessed,” he would say. He staged searches and threw all my things out of my bunk drawers across the cell. He often removed my private diary, so I played cat and mouse, keeping my notebook on my person. I agreed to write a separate monthly “record of my progress” for him, but I only listed his abuses. He would write “good” on each page like a teacher. He obviously did not understand my handwritten English. The prison was a business, doing manufacturing jobs for companies. Mornings, afternoons and often during the after-lunch nap, prisoners “laboured” in the common room. Our men made packaging parts. I recognised well-known brands — 3M, C&A, H&M. So much for corporate social responsibility, though the companies may well have been unaware that prison labour was part of their supply chain.
Prisoners from Chinese cell blocks worked in our factory making textiles and components. They marched there like soldiers before our breakfast and returned late in the evening. The foreigners who laboured in my cell block were Africans and Asians with no money from family, and no other way to buy toiletries and snacks. It was piece work; a hundred of this, a thousand of that. Full-time, they earned about Yn120 (£13.50) a month. But it was also about points. There was a sentence-reduction system based on points earned through labour — work such as floor cleaning, food serving, teaching and approved study. Snitching also earned favourable treatment. Our life was a waiting game. No family visits. No letters home. Just brief messages to lawyers Once or twice a year a list of prisoners went up showing who had earned reductions.
Those on long terms crowded around, praying their name was on the board. Many were disappointed. Reductions had become rarer since President Xi Jinping had taken power in early 2013. Before that, a 10-year term might be cut to seven. Under Xi you would be lucky to get one year taken off. I never qualified because I boycotted the thought reports. The officers refused to explain the system to me anyway. Between bouts of persecution by Wei, I read books and newspapers sent by my Rotary Club community, and books from the prison “library” shelves managed by Stern Hu, a China-born Australian. Stern had led the China office of mining giant Rio Tinto before his arrest in 2009 on murky allegations of espionage and bribery, as China fought Australia over the price of iron ore. Ironically, I had commentated on his case on CNN at the time. Now I was his jailmate. Tall and aristocratic-looking, hair whitened by captivity, he was highly educated and very kind. He provided me with some of his warm clothing in winter and helped me with Chinese letter writing and reading. He was struggling with heart disease, and I worry about his health to this day. Every encounter was an education. I had spent 15 years helping to prosecute fraudsters. Now, in prison, I met many people who might easily have been my investigation targets, but who I came to believe did not deserve such harsh sentences. I came away from my captivity with sympathy for both the innocent and the guilty. I continued to refuse to “confess”, and the captains continued to block my access to prostate treatment and warm clothing. Everybody was supposed to shave once or twice a week. Prisoners had their own razors, which were stored under lock and key. On certain days of the week the razors were handed out to their owners to shave and then handed back in immediately. I applied to have my family buy me a razor, but Wei kept blocking approval. They tried to make me use a shared razor
. I refused on hygiene grounds. I grew a long straggly grey beard. Hair was cut every Saturday morning by prisoners. I let mine grow. Before long, I looked like a cross between Santa Claus and the Count of Monte Cristo. This drove Wei nuts. He tried to force me to shave, and I filed complaints to the prison and my consulate. Other prisoners started winking at me as I walked along the corridor and I noticed they had started to grow beards too. My consular saviours — Roslyn, who took over from Usha, and Susie — brought letters and books from relatives and friends each month, and relayed my complaints to the prison and the authorities. One day, they brought me a copy of the United Nations treaties on imprisonment and torture that I had requested. These confirmed to me that China failed to comply with most of the standards of treatment (on nutrition, sleep, labour, health, contact with family, etc) required by international laws that China had signed, and I urged my consul to complain. I shared the treaties among the inmates. Handwritten copies proliferated. Some of the men started citing the treaties in complaints to the governor. The officers began to grow uneasy and I could sense that some wanted to get shot of me. Wei continued to threaten me with solitary and made efforts to ban me from sitting down anywhere. In April 2015, something shifted. Consular lobbying and my relentless complaints forced the prison to send me for a PSA blood test and an MRI at a local hospital. Wei used the moment to parade me in front of the public at hospital in handcuffs and prison uniform. But the MRI result was a milestone.
Within weeks, they had to admit that I had a tumour in my prostate, although they concealed the result of the the blood test. The next step should have been a biopsy. Instead, they began to fake the paperwork for a sentence reduction for good behaviour. It emerged from this that the real commander of cell block eight was one Captain Shang. He, and eventually the prison governor, spent long sessions pleading with me to sign an admission of guilt so that I could leave prison with Ying, whose sentence would expire on July 9 that year. “Even your wife could get a small reduction too,” said Shang. He and I argued over the wording of a compromise statement that I would sign to satisfy the paperwork. He went back and forth to his superiors with my position. I finally signed a statement expressing qualified, conditional remorse if I had done anything wrong but not admitting that I had done anything wrong at all. Somehow they fudged it. I came away from my captivity with sympathy for both the innocent and the guilty On June 4 2015, the prison smuggled me to the Shanghai Prison Hospital where I never saw a doctor but where they pretended I was getting medical attention for five days. The vice-governor came to me with a Gillette Turbo razor and begged me to use it. In my final act before leaving Qingpu, I shaved. On June 9, they released Ying and me into house arrest in the Magnotel, a small hotel that sources said belonged to the security apparatus, pending our deportation. On June 17, the PSB men who had originally arrested and interrogated us in 2013 conveyed us to Pudong Airport to deport us on a Virgin flight to London. Just before we climbed aboard, the PSB handed us a bill for our nine-day stay in the Magnotel. We didn’t have the cash with us, so we signed an “IOU”. Postscript After deportation to the UK in 2015, Peter Humphrey was diagnosed with advanced prostate cancer, and spent 18 months in cancer treatment and one year in PTSD treatment.
He fought a 21-month legal battle against the Home Office over Yu’s right to stay in the UK and won in court. He filed a detailed report to the Beijing government on Shanghai’s abuse of China’s judicial system and awaits a reaction. He and his wife have filed suit against GSK in US courts on racketeering charges. His damaged health has prevented his return to business and he has reverted to his journalistic and academic roots as a sinologist and writer. He was banned from China for 10 years but does not rule out a return when conditions are favourable. Doing business in Xi’s China Peter Humphrey during his “confession” on Chinese state TV, August 27 2013 When Peter Humphrey was arrested by Chinese police in July 2013, the world still knew very little about China’s new president and Communist party general secretary, Xi Jinping. It seems naive now, but five years ago many people hoped Xi’s administration would press ahead with difficult economic and perhaps even political reforms. The cases brought against Humphrey, his wife Yu Yingzeng and their corporate client GSK were some of the first indications that the international business community was about to enter uncharted territory as Xi quickly established himself as China’s most powerful leader in decades
. GSK was one of the first corporate casualties of Xi’s anti-corruption campaign, which has been unprecedented in scope. Shanghai police charged the UK company’s staff with paying doctors billions of dollars in kickbacks. Humphrey, a former Reuters reporter turned private investigator, was charged with illegally obtaining private information. His case was never officially connected to the GSK investigation, but few people doubted that he had appeared on the authorities’ radar because of his work for the UK pharmaceutical giant. Humphrey’s ordeal also presaged a dramatic deterioration in China’s human rights environment. His “confession” while under detention, which was broadcast by state television long before his trial, is now a common tactic employed in government prosecutions of Chinese human-rights lawyers, labour organisers and other activists. By Tom Mitchell in Beijing Inside China’s prison system According to the Ministry of Justice, under which the Bureau of Prison Administration operates, there are about 700 corrections facilities throughout China. The official reported rate of incarceration is 119 per 100,000, with 1,649,804 sentenced prisoners, but this statistic excludes pre-trial detainees and those held in administrative detention. A 2009 report from the deputy procurator-general of the Supreme People’s Procuratorate found that an additional 650,000 prisoners were held in detention centres throughout China. Although the Chinese government officially states that its correctional institutions do not use torture as a method to extract information, a Human Rights Watch report from 2015, quoted in a US State Department report, found “continued widespread use of degrading treatment and torture by law enforcement authorities” and revealed: “Some courts continued to admit coerced confessions as evidence, despite the criminal procedure law, which restricts the use of unlawfully obtained evidence.” The state department report went on to note “a lack of due process in judicial proceedings, political control of courts and judges, closed trials, the use of administrative detention, failure to protect refugees and asylum seekers, extrajudicial disappearances of citizens, restrictions on non-governmental organizations (NGOs), discrimination against women, minorities, and persons with disabilities”. By Ian Trueger
I have to say fair play to Carmine Pariante for debating Joanna Moncrief in this live Q and A on YouTube. I don’t agree with many of his views on SSRI’s, however I thought it was interesting that (in a response to a question for Bob Fiddaman) he seemed to think that Seroxat (paroxetine) ‘has one one of the worst side effect profiles and withdrawal symptom profiles” and ‘as a clinician’ he doesn’t use it’…
Good to hear that he wouldn’t touch Seroxat with a barge pole, however what about all the tens of thousands of people who had to suffer Seroxat’s horrors? what about the Seroxat suicides? what about GSK’s behavior in relation to it?
Were we all just psychiatry’s human guinea pigs Carmine?
Great to see some news on this story that I have been highlighting for some time now..
The Federal Government is supporting Labor’s demand for a Senate inquiry into the use of controversial anti-malaria drugs in the Australian Defence Force.
Mefloquine and tafenoquine trialled on ADF personnel from 1999 to 2002 deployed to East Timor and in Bougainville and have reportedly caused disorders such as schizophrenia, hallucinations, seizures and even self-harm among some veterans.
An investigation by the ADF’s Inspector General in 2015-2016 found the drug trials were conducted ethically and in accordance with guidelines.
Defence Minister Marise Payne said during her visit on Tuesday to joint US-Australian exercises in the Northern Terriroty that the government would support Labor’s plan for a Senate inquiry.
Asked by a reporter for her response to the federal opposition’s move, she said: “The government will support that inquiry. I will, from my perspective, ensure that Defence provides whatever material that the committee requires of it and work closely with Minister [Darren] Chester to make sure the Department of Veterans’ Affairs similarly supports the inquiry.”
The inquiry would examine reported adverse effects of mefloquine and tafenoquine among veterans.
The move comes after nine.com.au reported two federal Labor MPs were calling for an investigation.
How nine.com.au reported the calls for an urgent inquiry into the use of anti-malaria drugs by the ADF.
Note: If you are reading this Gerard, please e-mail me on email@example.com
I would love to chat with you.
ThanksOpmerking: als je dit leest, stuur me dan een e-mail op firstname.lastname@example.org Ik zou graag met je chatten. Bedankt
“..Afterwards you start thinking and looking back at your life, suddenly the penny fell: It is not my nature to be aggressive or anxious.” – Gerard Eggebeen
Gerard Eggebeen (32) used Seroxat for years. First prescribed it in his teens for depression, and then suffering serious side effects for years, he recently successfully sued GlaxoSmithKline and won.
The verdict of the judge only caused a brief moment of happiness. “Imagine the world as colorless, everything is gray and matt and nothing makes sense, that’s how I feel every day.” Gerard has little hope that he will ever get rid of his depression again. His struggle against the pharmaceutical giant keeps him going.
Since Gerard knows what damage seroxat has caused him, he sees it as his mission to get justice for himself and others.
“I will not rest before this mess is for everyone under eighteen of the market and people who have suffered from it experience a sense of justice,” he says. “The idea that someone is sitting somewhere in a skyscraper at GSK, who now knows what they have done to people…”
See these articles in Dutch (use google translate to get an ok gist of it in English) for more:
the ecosystem approach to obgyn
Finding joy in my 60's
Poetry, Short Stories and Violent Ideas
Better to understand a little than to misunderstand a lot. I'm just being me!
Do I contradict myself? Very well, then I contradict myself.
A radical perspective on local, national and international issues from the pens of a few disgruntled agitators!
Follow me on Twitter and Instagram @RichyDispatch
sustainability. compassion. inspiration.
E-mail : email@example.com
....I love You beyond words. Save me Lord. I will not let go of You. Hear me O' Lord. In Christ's Powerful Name Amen ~ Brandon Heath
becoming not being.......
Because Social Media increases Awareness and brings the DES Community Together
people can and do recover from what is sometimes called "mental illness"
I have people to kill, lives to ruin, plagues to bring, and worlds to destroy. I am not the Angel of Death. I'm a fiction writer.