http://www.guardian.co.uk/commentisfree/2013/may/10/gsk-save-the-children-aids-drugs-africa
Charity and Big Pharma make uneasy bedfellows
The alliance between GlaxoSmithKline and Save the Children is a pragmatic one that will do good. But is it the best way forward?
- guardian.co.uk, Friday 10 May 2013 15.56 BST
- Jump to comments (28)
Andrew Witty on a visit to Katine … he has said that GSK must do what it can to improve the health of people in poor countries. Photograph: Martin Godwin for the GuardianDevelopment charities and multinational drug giants have not always appeared obvious bedfellows. The International Aids Conference that takes place every two years – last year in Washington DC – used to be famous for the trashing of drug company stands by activists who had at least the sympathy of mainstream charities. Red paint, for the blood of those who could not afford the price of drugs to keep them alive, flowed in the halls.
So the union of Save the Children and GlaxoSmithKline, launched yesterday in Kenya, is something of a landmark moment. It raises questions about Big Pharma and about the future direction of NGOs and development as a whole. And it has left a number of people working in aid feeling very uncomfortable.
Save the Children and GSK talk of the five-year partnership as a groundbreaking new deal. GSK will reformulate products and develop others in line with Save the Children’s advice on what poor countries really need to save babies’ lives, while helping to train healthworkers. GSK’s chief executive, Sir Andrew Witty, says it is all about speeding things up. From the realisation that babies die for lack of antibiotics to making available a dose-sized pack of powder that families in Africa can use (if they have clean water) takes too long. Witty wants to cut through grindingly slow bureaucratic processes. If he says “jump” in GSK’s west London or Philadelphia corporate HQs, people jump. Things get done. That’s what they are paid for.
Witty and Save’s chief executive, Justin Forsyth, have been moving towards this union for some time. Witty has declared that his company must do what it can to improve the health of people in poor countries. Since 2009, he has made a series of moves, from cutting the prices of GSK’s drugs in the poorest countries to reinvesting 20% of the profits they make locally. This is, he says, another step on that road.
Forsyth is a mover and shaker, who arrived to head Save the Children from Downing Street, where he was director of strategic communications for Gordon Brown, having previously worked for Tony Blair. He ran the communications strategy for the London G20 summit. He is another man who believes in getting things done. For Save, this is a pragmatic move. Money is short in development and getting shorter as the economic situation does not improve. Increasing amounts of the Department for International Development’s funding look likely to be spent on what used to be called defence. All aid organisations are looking for more help. Big Pharma has shedloads of cash. GSK made nearly $9bn in profits in 2011.
But does the link-up of GSK and Save wash away the sins of Big Pharma? It will do GSK’s reputation no harm at all, but it won’t stop the criticism. It was muted yesterday, because NGOs do not want to throw mud at each other, but there were plenty who did not feel like throwing confetti. If GSK really wants to do good, says Médecins Sans Frontières, it should pledge truly low prices for all its HIV drugs in the developing world.
Health Action International is blunter. It fears an agenda set in London, a programme of good works that will run in parallel with the domestic policies of the governments of Kenya and the Democratic Republic of Congo (DRC) and risk undermining them. “Has anyone consulted, and really found out, what is required or is this initiative driven by the needs of CSR [corporate social responsibility], and, it has to be said, an organisation that, like us all, is looking for funds in the face of economic crisis?” asked Dr Tim Reed, its executive director.
The partners aim to save the lives of a million babies. It’s hard to argue with that. And it’s a safe bet they will. But the debate over whether this is the best way to do it will run and run.
EmailSeroxat by Kirk Brandon
Everyone smiling, and waving.
Paxil, Seroxat- Paroxetine Generation.
Brave New World
GlaxoSmithKline- Meet the Dealer.
Millions of people in this world of confusion
And the company and its doctors actively pushed the solution
Happy pills that turned men into killers.
And the company even tried to get a license to give it to children.
The will to kill- and the days filled with rage.
Addiction
Suicide
Halucinations.
GSK- Prophets of despair.
Daily rising.
There’s more than me- that’s watching you
Glaxo Transparency… Plus Conflict of Interest Of Course…
http://www.pharmalive.com/glaxo-and-transparency-one-panel-member-has-a-conflict
Seven months after promising to release clinical trial data, GlaxoSmithKline has created an online system for researchers to request access to patient-level data and released the names of a group of experts who will review requests from outsider researchers seeking to examine trial data. The drugmaker maintains the effort will make it possible for outside scientists to study Glaxo data and develop their own findings about safety and effectiveness (back story).
However, one member of the panel - which is described as independent and will be tasked with reviewing data requests – has previously worked as a consultant to the drugmaker. Brian Strom, a professor of public health and preventive medicine, and also a professor of biostatistics and epidemiology of the University of Pennsylvania, received $5,500 last year, according to the ProPublica database (see the data here).
“That’s the challenge when individual companies set up their own review panels,” says a Glaxo spokewoman. “We won’t have influence over the panel decisions. We’ve said it won’t be perfect first time out, but the important thing is to be transparent about it… We’re trying to make this attempt to put this effort forward. Maybe this can accelerate the discussion about what is the right system.” She added that Glaxo wants to retain an independent third party to eventually oversee this system and, at that point, the panel may be superceded or even dissolved.
[UPDATE: Strom writes us this: "My role on the committee is completely independent. GSK does not have any say in our decisions.... The story here is someone in industry is looking to do it right. I'm an academic. I gave them advice about what this should include. This is a major scientific advance. There are big things that can come out of here, especially if other companies join... The fact that I did consulting in the past is not news... Our choices are going to be independent... I'm independent. My funding comes from an academic center... You can't say go to industry and say get the best people in the industry and then criticize them when they do."]
As noted previously, the move comes after years of controversy over the extent to which drugmakers disclose clinical trial data. The pharmaceutical industry has long been criticized for failing to fully make underlying patient-level data available to others who seek to verify results. Drugmakers have insisted the data is proprietary, but critics have said the reluctance to disclose such information can be a red herring for hiding unflattering results that may limit sales.
The debate has factored into numerous scandals in which drugmakers have been accused of withholding important information about side effects. Glaxo, in particular, was cited for such behavior with its Avandia drug, which figured prominently in a $3 billion settlement the drugmaker reached last year with the US Department of Justice for a number of infractions.
The feds claimed that, between 2001 and 2007, Glaxo failed to include certain safety data about Avandia in reports to the FDA. The missing info included data from post-marketing studies, as well as data about two studies undertaken in response to European regulatory concerns about cardiovascular safety. Glaxo (GSK) agreed to plead guilty to failing to report data to the FDA and to pay a $242.6 million criminal fine (see this).
In agreeing to disclose data, Glaxo also has been at odds with two industry trade groups. Three months ago, the drugmaker publicly supported the AllTrials campaign in its quest to have patient-level data released, a move that PhRMA and the Association of the British Pharmaceutical Industry have opposed (read more here).
Only one other drugmaker has taken any similar steps. Last month, Roche said it would make available data from all 74 clinical trials for its Tamiflu treatment to a team of Cochrane Collaboration researchers. That came after the drugmaker agreed to widen access more generally for clinical trial information for its medicines in response to increased pressure from academics and a widely publicized online petition (back story).
As for Glaxo, the drugmaker plans to list trials on a new web site once a medicine has been approved by regulators or terminated from development and the study has been accepted for publication. Studies that do not progress to publication will also be included. The site already includes global studies conducted since 2007. Over the next two years, global studies going back to the formation of GSK in December 2000 will be added. In addition, all studies starting in or after 2013 will be included, the drugmaker says.
The system would be run by an independent third party that would be responsible for appointing and overseeing a review panel to assess research proposals. “We are the first organization to develop a system for sharing detailed clinical data in this way. Now we want to see this initiative transition to a broader independent model that brings together data from multiple organizations,” says Glaxo pharma R&D president Patrick Vallance in a statement.
He did not offer a specific timeline for retaining a third party to run the initiative. For now, the members of the independent review panel - in addition to Strom - include Marc Buyse, an associate professor of biostatistics, Hasselt University Belgium and founder of the International Drug Development Institute; Bartha Maria Knoppers, who heads the Center of Genomics and Policy at McGill University; and John Hughes, the patient and public involvement member of the UK Clinical Research.
Irish Psychiatrist Jim Lucey Admits That Diagnosis In Mental Health Isn’t About The Cause
Irish broadcaster Pat Kenny regularly carts out the Irish Biological Psychiatrist Jim Lucey on his radio show. I’ve been listening (and reading between the lines) of his interviews. They can be listened to (and downloaded) on this link:
http://www.stpatrickshosp.ie/prof-jim-lucey-pat-kenny
One that is particularly interesting is “Does Depression Really Exist?”.
In this interview , Lucey admits that Psychiatric Diagnosis isn’t about addressing the cause, he says it’s about diagnosing the symptoms in order to label depression.
One listener asked a question, “would I be on Effexor for the rest of my life”? “I’m worried and I don’t know what to do”.
Lucey seems to think that if someone has 3 re-current depressions due to stopping treatment- which he calls re-lapses- that they should stay on medication.
What Jim Lucey doesn’t say is- SSRI medications – like Effexor- can cause a withdrawal syndrome which mimics and often increases symptoms of depression and anxiety- therefore how does a psychiatrist diagnose re-lapse and differentiate between re-lapse into depression and SSRI withdrawal induced depression?
While I don’t doubt Jim Lucey believes in the biological model of psychiatry – it amazes me how he fails to see the dangers of prescribing a one-size-fits-all model for depression. Not once does he offer other alternatives- such as changes in diet, exercise, alternative therapies, nutrition, psychotherapy etc.
He says recurring depression might need a mood-stabilizer such as lithium. Perhaps a recurring depression needs intensive talk-therapy- not merely chemical intervention?
What he doesn’t address is the cause of depression in the first place- many factors which he mentions- such as grief, life-changes, environmental factors etc- he brushes over these and sees the individual purely in terms of symptoms instead of focusing on the root-cause.
Until the root cause of the depression is dealt with- chemical band-aid psychiatric drugs will not aid an individual in overcoming their depression. I speak from experience..
Discussing Mental Health entirely in biological terms, and aiming to treat Mental Health solely in chemical treatments, is extremely limited and does a great disservice to sufferers of depression and anxiety. Chemical treatments have clearly failed the majority of mental health sufferers, and perhaps it’s time that psychiatrists like Jim Lucey begin to see beyond the symptoms, the diagnosis and the ‘disease’, and into the essence of the individual.
The individual holds the key to their own recovery.
On RTE radio on Monday at the end of a debate on autism, Pat Kenny’s resident psychiatrist Prof Jim Lucey said Dr Gilsenan’s views were “a classic example of a single dimemsional divide” that occurs in the suicide debate. Not sure exactly what that means, but he went on to say there is “no evidence” that anti-depressants cause suicide, and referred to an “anti-psychiatry movement”. Prof Lucey instead preferred to blame alcohol for a rise in suicide. I was under the impression that we Irish had always drunk copious amounts, so why all of a sudden is it driving us to suicide? Perhaps the issue of alcohol mixed with legally prescribed drugs would be a more valid argument. Coroners up and down the country have been commenting on the number of cases where legally prescribed drugs are a factor in deaths.
Jim Lucey says that there is no evidence that anti-depressants cause suicide. This is blatantly untrue. Perhaps Mr Lucey would like to take a look at the tens of thousands of stories of SSRI induced suicide, murder and aggression on SSRI Stories- http://ssristories.com/
or maybe he would open his mind and read about the coroners reports of SSRI induced suicides on this website:
The Obvious Hypocrisies In The Irish Abortion/Suicide Debate
It might shock, or surprise, some of my international readers to know that abortion is still illegal in Ireland- and there is a right-wing Christian conservative element in Irish society that wishes to keep it that way- forever.
Thousands of Irish women leave Irish shores for the UK each year in order to have an abortion- a right they are denied in their own country.
The abortion debate has been re-ignited in recent times in Ireland, mainly because of the death of savita halappanavar. Savita was denied an abortion in Ireland even though there was a threat to her life. Because of her death the abortion debate has been thrust back into the Irish political and socio-cultural arena, with many opinions about abortion bandied about in the media- and elsewhere- throughout Ireland for the past few months.
In the Irish abortion debate- as in most countries- there are effectively two camps of divided opinions- the ‘pro-life’ side and the ‘pro choice’ side. But what makes this debate in Ireland particularly interesting has been the involvement of psychiatrists in the debate. I personally think it should be a woman’s right to choose, no matter what the circumstances, but for the purpose of this post I would like to concentrate mainly on the abortion and suicide issues- as I think as you will see- the raising of this controversial taboo has also flagged massive holes in the logic, legitimacy and credibility of Irish psychiatry in general- not just in relation to abortion and the threat of suicide because of it- but also in relation to the entire practice of Psychiatry in Ireland as a whole.
Current legislation is now being drafted in Ireland in order to address the blatant incongruities in Irish abortion laws. One of the controversial elements of this legislation includes a risk assessment of a hypothetical suicidal pregnant woman by psychiatrists. In Ireland- as it stands- there is a so called ‘equal right to life of both mother and fetus’. But there is also a stipulation that in cases where there is a substantial threat to the life of the mother- an abortion can be performed.This is where the threat of suicide comes in- as suicide is surely a valid threat to the life of the mother? Not so – it seems- according to some Irish psychiatrists.
David Quinn, director of the Iona Institute, a religious advocacy group which opposes abortion, said the organisation was “very concerned” at what was contained in the heads of the Bill, particularly in relation to the provision on suicide which he said, if implemented, would see Irish law “crossing a moral Rubicon”.
“The suicide provision is the most worrying provision in it because, if and when this becomes law, for the first time in Ireland, it will provide for the direct killing of an unborn child where there is an alternative treatment,” he said.
Mr Quinn reiterated the organisation’s contention that suicide was not a cure for suicidal ideation, a viewpoint which he said had been supported by 113 Irish psychiatrists who last week signed a statement indicating their opposition to suicidality as grounds for an abortion.
He said the organisation would also be reviewing the part of the Bill which deals with conscientious objection as to what implications this had for Catholic hospitals.
Anti-abortion organisation the Life Institute accused Fine Gael of “caving in” to Labour on abortion. Spokeswoman Niamh Uí Bhriain said the smaller Coalition party represented “less than 10 per cent of the people now, according to polls, yet they are deciding for the whole country on this issue of life and death”.
She said the Government “had ignored all the medical evidence that confirmed abortion was not a treatment for suicide”.
“This Government asked medical experts to give evidence on this issue, and the evidence they heard demolished the case for legalising abortion on suicide grounds, but now they have roundly ignored the evidence and moved to allow unborn children to be deliberately killed for the first time in Ireland.”
Although pro-choice groups welcomed the publishing of the heads of the Bill, they also expressed concern at some of the elements therein.
The Abortion Rights Campaign welcomed the publication as a step toward securing access to safe and legal abortion in Ireland but added that it was “deeply disappointed” by several sections of the draft legislation.
Spokeswoman Cathie Doherty said the campaign was “extremely alarmed” by the inclusion of the assessment of three doctors for termination when a woman is at risk of suicide.
“Requiring three doctors to assess a suicidal pregnant woman is outrageous. This legislation will be redundant if the women affected will continue to travel to England rather than face interrogation by multiple doctors,” she said.
Possible penalty
The organisation also labelled a possible penalty of 14 years in prison for illegal abortion in Ireland as “nothing short of barbaric”.
“To threaten women facing this difficult decision with imprisonment is not only wrong in and of itself, but it may prevent women from disclosing information about previous abortion to their doctors, or seeking medical care in the event of complications from illegal abortion,” said another spokeswoman, Sarah Malone.
Sinead Kennedy of Action on X said the organisation was “very disappointed” by elements of the Bill, particularly around suicidal ideation. She criticised the requirement for a suicidal woman or girl to receive the unanimous consent of three medical practitioners before an abortion could take place in these circumstances, describing it as a “callous disregard for women’s lives”.
Ms Kennedy also criticised the Bill for distinguishing between medical and psychiatric emergencies. “Psychiatric emergencies are medical emergencies and any psychiatrist will tell you that,” she said.
Now if you notice the play on words here, by David Quinn of the ultra-conservative Catholic Iona institute- he is claiming- with the apparent backing of 113 Irish psychiatrists – that ‘abortion is not a treatment for suicide’. Whoever said that it was? It is the threat to the woman’s life by suicide that is the issue. Nobody- apart from right-wing Christian fundamentalists- has alluded to abortion being a treatment for mental illness or suicidality but completed suicide and suicidality may indeed be the result of the trauma of an unwanted pregnancy. It seems that the ‘pro-life’ brigade are not so much ‘pro-life’ but merely anti-abortion in all circumstances- even if that means that a woman would take her own life because she cannot get access to an abortion procedure.
Psychiatrists in Ireland have been telling us for decades that suicidal thoughts should be taken with the utmost seriousness, that they are a sign of mental illness, clinical depression etc, and that psychiatric intervention should be sought immediately – because – they told us- suicide is life threatening and they tell us- depression itself is life threatening because of the risk of suicide.
Yet- 113 Irish psychiatrists have basically just come out and said that suicidality should not be taken seriously if that suicidal individual happens to be a pregnant woman- and suicidality- according to Irish psychiatry – should be viewed with suspicion, contempt and skepticism when that pregnant woman is also seeking an abortion because of it. In other words- they know that they can’t assess whether someone is really suicidal or not.
For decades psychiatrists have been telling us that they are the experts on suicidality but now they seem to saying that they can’t predict suicide. If – as they now admit- they cannot predict suicide, can they be trusted to diagnose ‘mental illness’ at all?
This undermines the credibility of the entire practice of psychiatry because it is their so called ‘expertise’ in matters of suicidality, in particular suicidality and its relation to mental illness -which are exposed under the spotlight by this debate. In effect, their expertise in matters of mental distress are revealed to be -not so expert -after all.
Do you see the gaping holes in the logic here?
On the one hand Irish psychiatry have been saying for years that depression is a life threatening illness solely because of the risk of suicide inherent with depression. But on the other- they are now saying that up to three doctors have to assess the ‘suicide risk’ of a pregnant woman before she is effectively deemed authentically suicidal enough to have an abortion. Or at least convincing enough to warrant an abortion in order to protect her life.
This is not about ‘abortion as a treatment’ for suicidal pregnant women- it’s the so called ‘pro-life’ brigade who have inserted this baseless mantra into Irish media discourse- this is about Irish psychiatrists caught up in their own religious views clouding reality- it is also about psychiatry in Ireland being unwilling and blatantly ill-equipped for the position which for so long they have claimed legitimacy over: the treatment of suicidality.
You can’t have it both ways.
Take for instance, the vociferous ‘pro-life’ opinion of Dr Patricia Casey, a member of the Iona Institute Catholic think-tank. Casey is a controversial Irish psychiatrist for many reasons which I won’t cover here but in the context of suicidality she says :
In practice, the risk of suicide, even in high-risk groups such as those with serious mental illness, is very low. And among pregnant women the risk of dying by suicide is lowest of all.
Casey states here that ‘the risk of suicide even in high risk groups such as those with serious mental illness is very low.’
That statement is completely at odds with what psychiatrists have been telling us for years- in particular in relation to the risk of suicide in depressed people. So all of a sudden- suicidality in serious mental illness is not really that much of a big deal?
She also says that the risk of dying by suicide is lowest of all in pregnant women. While this might be true- just because it’s a low risk- doesn’t mean it is zero risk. So effectively, Casey and her cohorts admit there is a risk – albeit low. Therefore what Irish psychiatry are really implying is- Irish women seeking abortions will lie about their suicidal states in order to get one and Irish psychiatrists don’t want to be involved in assessing or facilitating this process. Is this not insulting – not only to all women in Ireland? but does it not also demean the seriousness of suicidality itself? And furthermore does it not indicate the blatant hypocrisy of the Irish psychiatric profession, which for decades has claimed to be the only authority on ‘mental illness’, ‘suicide’, ‘depression’ etc?
Irish psychiatry have shot themselves in the foot once again. Abortion is a secular and civic debate, it is a human rights and personal rights issue. It is one of personal individual autonomy. Moral and religious persuasions should not influence professional and scientific opinions.
So hypothetically – if we be the devil’s advocate here- and take Irish psychiatry’s oxymoronic opinion that ‘abortion is not a treatment for suicidality’ then what do they suggest a distressed and pregnant Irish woman do if she is feeling suicidal? Presumably they will try to offer her psychiatric treatment? If so- what psychiatric treatment is available to a suicidal pregnant woman in Ireland. Well- according to Dr Moosajee Bhamjee- there is little or no ‘talk-therapy’ available in Ireland and the waiting lists for psychotherapy can be month’s long. Therefore- I presume that the ‘treatment’ available to a depressed and suicidal pregnant woman in Ireland would predominantly be SSRI drugs?
SSRI drugs are known to cause birth defects, they can also be addictive and cause severe side effects- which includes suicidal ideation, aggression, etc.
Is this really an adequate treatment for a woman who is already depressed, anxious, suicidal and traumatized by an unwanted pregnancy? Or will the panel of psychiatrists who are called upon to assess whether she is adequately suicidal enough, or at least convincingly suicidal enough -permit her to have a medical procedure which might save her life? Or faced with a draconian style inquisition of skeptical and intimidating psychiatrists- will, emotionally fragile and distressed, pregnant Irish women continue (as they have done for decades) to seek proper medical care elsewhere?
Only time will tell..
Personally I think Ireland needs to propel itself pronto into the 21st century.
The Catholic church has had a strangle-hold upon the monopoly of morals, how people live, their sexual persuasion, what they should believe, their marriage rights and their education for far too long.
Irish psychiatry has also had unquestionable authority upon the ‘mental and emotional’ health of Irish citizens for far to long too…
Despite the fact that both are utterly corrupt- and in the case of Irish Psychiatry – utterly devoid of compassion, logic and reason…
Ironically- the Irish psychiatrist Dr Veronica O’Keane seems to be the only one who sees sense.
Although I am not a fan of her opinion on SSRI drugs- but when it comes to abortion and suicide -at least someone in Irish psychiatry seems to possess an iota of humanity and logic:
Professor of Psychiatry at Trinity College Dublin Veronica O’Keane has said psychiatrists are legitimately deemed best placed to assess suicide risk and if there was a mental illness in a woman it would be their role to treat that illness.
Speaking on RTÉ’s Today with Pat Kenny, Dr O’Keane said if there was the presence of mental illness it sometimes would make a doctor less likely to recommend an abortion.
She said situations are different, and she thought it was much easier to make a decision in the absence of mental illness.
“I think this legislation is primarily for women who are suicidal because they have an unwanted pregnancy and that is the only way of resolving their suicidal problems – is to have a termination,” she said.
Responding after the programme, Psychiatrist Prof Patricia Casey said that the legislation will allow for abortion in the case of women without mental illness, who simply do not wish to give birth to an unwanted baby.
Prof O’Keane also described as “an absolute farce” a survey by a “pro-life” group that claimed 120 psychiatrists who responded did not agree with proposed legislation to legislate for the X Case based on the suicide provision.
Prof Keane said it was a survey conducted by a statedly-biased group and it was done without the permission of the College of Psychiatry Ireland.
She said that those conducting the survey had not gone through the college’s procedures and the survey would not have passed through the college’s guidelines.
She said the survey did not represent psychiatrists.
Describing the survey as it stood as “incomprehensible, and garbled”, she said it did not make any sense.
Prof Casey threatened to leave the studio if she could not respond.
Prof Casey said that the reason they did not do the survey through the college was because they could not get the names of the college membership, in relation to a previous study.
So, she said, when this study was happening she said that “they could not get the numbers from them”.
In a statement following the programme, Prof Casey said: “This was not a College of Psychiatry survey, nor did it purport to be. It was a letter that was sent, asking consultant psychiatry colleagues if they agreed with a particular statement, relating to the involvement of psychiatrists in relation to the current abortion proposals.
“The issue of obtaining permission from the college does not apply. We received a 42% response rate, and it cannot be reasonably argued, by Prof O’Keane, that it was incomprehensive. The overwhelming majority agreed with the statement.
“The question of peer review does not arise.”
http://www.rte.ie/news/2013/0503/390162-fianna-fail-pregnancy/
For an interesting insight into the hypocrisies of the abortion/suicide debate – check out the podcast from RTE’s Pat Kenny here:
http://www.rte.ie/radio1/today-with-pat-kenny/podcasts/
http://www.tv3.ie/3player/show/41/62035/0/Tonight-with-Vincent-Browne
http://leoniefennell.wordpress.com/2013/05/04/patricia-casey-v-veronica-okeane/
Savita Halappanavar
The Seroxat Patient Information Leaflet and How GSK Try To Mystify The Reality Of Serious Side Effects : Bob Fiddaman Investigates…
Great post by Bob Fiddaman over at Seroxat Sufferers Blog (more on this later)..
Check it out..
http://fiddaman.blogspot.ie/2013/05/patient-information-or-litigation.html?spref=tw
Thursday, May 02, 2013
Patient Information or Litigation Disclaimer?
I was browsing through some SSRi patient information leaflets [PILs] earlier and have come to the conclusion that the manufacturers warnings about this, that and the other are merely coded messages to the consumer.Years ago, when SSRi’s first hit the market, there were few warnings of side-effects. Sure, back then we had dizziness, nausea, sweating etc but that’s standard for most, if not all, prescription medicines.
Today, after US litigation, patient reporting and, it has to be said, internet activism, the PILs take on a completely different look. They [the manufacturer] are telling us we can’t sue because we were told.
It’s almost as if pharmaceutical compliance departments had a eureka moment and turned really bad news into something that could be productive in the future. “Hey if we stick broad but vague warning labels on our drugs then we cover ourselves from future litigation… quick, get the number for that medical ghostwriting team we used back in 1998″
Let’s take a look at Seroxat for example. [NHS Information]
Motion to dismiss
1. Some people who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment.
Very vague statement but one that would certainly be used by GlaxoSmithKline attorneys if they were ever faced with a lawsuit. “There is no case for your client as my client clearly stated in the patient information leaflet that Seroxat wasn’t for everyone.”
2. “If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide.
“If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible.”
Again, Glaxo attorneys could have a field day, “Your honour, we have reason to believe that the deceased did not contact their prescriber, yet my client clearly stated in the patient information leaflet for them to do so if they were feeling suicidal, therefore we argue that there is no merit in this case”
3. Seroxat is not suitable for everyone and some people should never use it.
“Your honour, if the deceased had killed themselves by touching an electrical fence despite there being a warning not to do so would my learned friends still be representing him in court?”
4. Over time it is possible that Seroxat can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately.
“Your honour, the plaintiff may have become, over time, unsuitable for our client’s product, he may also have had an adverse reaction to my client’s product. At no time, leading up to his attempted suicide, did he contact his prescriber despite the fact that my client had advised this in the patient information leaflet.”
5. You should only take this medicine during pregnancy if your doctor thinks that you need it
“Your honour, whilst my client has every sympathy for the birth defects the child in this case was born with, it was not my client’s fault. My client never prescribed Seroxat to this young mother, it was her doctor.”
6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth
“Your honour, how many warnings did this mother need, was she illiterate, could she not read? My client refutes any responsibly with regard to the plaintiff’s son being born with septal heart defects. In fact, my client believes that it should be the plaintiff who should be facing prosecution for acting irresponsibly.”
7. This medicine may decrease fertility in men.
“Your honour, he was warned.”
8. Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.
“Your honour, my client blames the plaintiff and both the doctor and midwife, they should have read the patient information leaflet.”
Judge’s summation - Sadly, it is with great regret that I am granting GlaxoSmithKline motion to dismiss on the grounds that they covered all bases for any future litigation by applying warnings to their patient information leaflet. I am, however, recommending that in future Glaxo elaborate on the warnings. My recommendations are underlined:
1. Some people, particularly those who are poor metabolizers, who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. GlaxoSmithKline nor your prescriber cannot tell you if you are a poor metabolizer so, in essence, by administering Seroxat you are playing solo Russian roulette.
2. If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide. Changes such as an increase in depression, anxiety, an inability to sit still, a lack of empathy toward others, excruciating electric-like zaps in your head, horrific nightmares where the subject matter is death, homicide, suicide. Outbursts of anger, for no apparent reason, aimed at those you love. If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. NHS Direct et al should then telephone a 24 hour hotline, manned by an independent body who have no financial ties to GlaxoSmithKline, and request a safe withdrawal protocol. The patient should be hospitalized, at GlaxoSmithKline’s expense, and monitored at regular intervals. Any item of clothing that could be used as an instrument for suicide must also be removed. GlaxoSmithKline’s CEO, Sir Andrew Witty, should be contacted, no matter what time of day or night it is. Sir Witty may then realise that bad things didn’t just happen to patients under JP Garnier’s watch, they are still happening and are not part of “an era”. Sir Witty can sit with the patient while he/she experiences thoughts of self-harm and/or suicide. Because of the logistics and vast number of people who suffer these kind of adverse reactions to Seroxat it is recommended that Sir Witty handpicks a team of GlaxoSmithKline executives to be on emergency call to tend to the needs of Seroxat induced suicide victims.3. Seroxat is not suitable for everyone and some people should never use it. Some people cannot excrete Seroxat from their system quicker than others. This means that they build up toxic levels of the drug, in fact these people are overdosing on Seroxat without actually knowing it. This simple fact should be made crystal clear in future patient information leaflets. Sir Witty and his handpicked team of executives should disseminate this information to the public by word of mouth. Alternatively a full page advertisement can be used in popular mainstream newspapers to warn this vulnerable patient population. “Toxic levels of Seroxat may lead to self harm and suicidal thoughts” should also be added to the patient information leaflet.
4. Over time it is possible that Seroxat can become unsuitable for some people, particularly those who are poor metabolizers, or they may become unsuitable for it, particularly those who are poor metabolizers, If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately. The Prescriber should then contact GlaxoSmithKline to file an adverse reaction report. In turn GlaxoSmithKline should investigate the adverse reaction and report back to the prescriber with a causality assessment. This will then help the prescriber decide, in future consultations with patients, if Seroxat is the drug for them.
5. You should only take this medicine during pregnancy if your doctor thinks that you need it – This whole sentence needs drastic change. A doctor does not have access to the rat pup studies that GlaxoSmithKline has and kept from the public. Expectant mothers should be made aware of the Sloot study whereby Seroxat and other SSRi’s were exposed to rat fetuses. Out of all the SSRi’s used in this study only one came out as a clear teratogen – Seroxat. Another example of a teratogen, in case consumers are not aware of the word, is the anti-nausea and sedative drug, Thalidomide.
6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth. The sort of ‘problems’ are:
Persistent Pulmonary Hypertension of the Newborn (PPHN) – 6 times increased risk
Anencephaly (fatal neural tube defect) – 2.5 times increased risk
Clubfoot – 5 times increased risk
Craniosynostosis (craniofacial defect) – 2.5 times increased risk
Omphalocele (abdominal wall defect) – nearly tripled risk
Gastroschisis (abdominal wall defect) – 30 percent increased risk
Pulmonary Atresia – 3 times increased risk
Spina Bifida – 60 percent increased risk
Diaphragmatic Hernia – 80 percent increased risk
Anal and Esophagal Atresia – 30 percent increased risk
Heart Defects – nearly doubled risk
Septal Defects, including Atrial and Ventricular (also known as “hole in the heart” defects)
Hypoplastic Left/Right Heart Syndromes
Malformed or blocked heart valves that will not close
Transposition of the Great Arteries
Tetralogy of Fallot
Mitral Valve
Heart murmur
Like packets of cigarettes I make the recommendation that GlaxoSmithKline add a photograph to the packaging of Seroxat. An example is below.
Spina Bifida – 60 percent increased risk when taking Seroxat [1]
7. This medicine may decrease fertility in men. Given recommendation 6 this may not be such a bad thing, particularly if the female partner is also digesting Seroxat. Sir Witty and his team of handpicked executives may wish to visit any male patient who has decreased fertility as a result of taking Seroxat and, if requested, help to fill out some adoption forms for the wannabe father. GlaxoSmithKline shall foot the bill for the whole adoption procedure, including lawyers fees and expenses for the child up to the age of 19.
8. Before you have your baby you should discuss breast-feeding with your doctor or midwife as Seroxat can find a way into your baby when he/she breast feeds. This can cause serious implications for the newborn child and may result in Seroxat overdose, addiction, agitation and in some instances death. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. They will also offer you the court transcripts from the Kilker Vs GlaxoSmithKline birth defect trial where GlaxoSmithKline were found guilty for manufacturing a drug [Seroxat] that caused Lyam Kilker to be born with heart defects. This will help expectant mothers to make a fully informed decision and may deter them from breast feeding given that Seroxat can harm a baby whilst it is still in the womb so chances are the baby can be harmed if ingesting breast milk that is still in the mother’s system. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife and with the knowledge that your doctor or midwife actually know what they are talking about.I make these recommendations with the knowledge that healthcare professionals and GlaxoSmithKline have the right to ignore them as do global medicine regulators and coroners. In fact, the word ‘recommendation’ means nothing. It just makes people like me seem as if I really care when in actual fact I’m just recommending what I think should be done but I know that the likelihood of any recommendations made simply means that nothing has to be adhered to. I’m a Judge and I have to be seen to be doing something. I use war as an example. World leaders got together to fight the might of Hitler. At some point it was only recommended that they intervene. They didn’t have to but because they did they stopped Hitler, some would suggest that those recommendations to intervene should have been carried out earlier, maybe more lives would have been saved. Thing is, those recommendations were listened to, they were put into place and we are a better world for it.
I would urge for GlaxoSmithKline’s CEO and handpicked executives to search their consciences but past litigation [in the US] has shown that these individuals blame everyone and everything but their product.
I would like to recommend that Seroxat is removed from the shelves but know I would face tough opposition from those who have been duped into believing that the benefits of this particular antidepressant outweigh the risks. The risks, all of them, should be printed out in clear laypersons terms, again, I can only recommend this. I do know that, after reviewing all the court documents in cases such as Seroxat induced suicide, Seroxat birth defects, Seroxat withdrawal/addiction, that I will never allow any family member of mine to take this drug. That’s my privilege as I am a Judge.
Glaxo’s motion to dismiss – Granted.
Rt Hon Judge I.M Pointless
**Footnote**Later that year the Rt Hon Judge I.M Pointless granted the same motions to Eli Lilly, Wyeth, Pfizer, Forest Labs, Lundbeck and other SSRi manufacturers, including those manufacturers that make generic versions of SSRi medication.
He also made similar recommendations.[1] Birth Defects Cased By Seroxat [Birth Defect Resource]
Bob Fiddaman
GLAXOSMITHKLINE UNVEILS NEW PAXIL FOR BABIES ?
TAKEN FROM:
http://www.funnyordie.com/articles/a3ccf66ea1/glaxosmithkline-unveils-new-paxil-for-babies
GLAXOSMITHKLINE UNVEILS NEW PAXIL FOR BABIES
By dylanrhymer July 3, 2012 | 32 Views(LONDON) – Despite disastrous press surrounding their current $3B fraud settlement, the British pharmaceutical giant GlaxoSmithKlein is moving ahead with the release of a controversial new product: antidepressants for babies.“On behalf of GSK, I want to reiterate that we have learnt from the mistakes that were made. We’re eager to put this unfortunate business behind us and move ahead.” said Chief Executive Sir Andrew Witty at an unveiling “That’s why we are excited to unveil our latest product: NatalPax, antidepressants for babies.”
Glaxo’s ‘NatalPax’ will be the world’s first ever anti-depressant especially developed for babies 18 months old and younger.
“Every mother knows the sting of a baby that won’t stop crying and cannot be reassured, only to sleep for a few hours and wake up crying and then fall asleep with a bottle in their hand. At GSK, we recognize these are all classic symptoms of Social Anxiety Disorder.” He added “Sometimes a sad baby is really a S.A.D. baby.”
GSK developers point to the fact that, to a baby, side-effects like vomiting, diarrhea, fatigue and anal leakage are just part of every day life.
Said Witty; “Paxil is for everyone, so consult your pediatrician today.”
