The new improved Advocates of Transparency? 'The House of GSK'January 23 2014 at 5:39 PM
The House of GSK
November 14, 2013
In a just published article in the BMJ, Peter Doshi notes how in recent months the English pharmaceutical company GlaxoSmithKline (GSK) have assiduously portrayed themselves as advocates of transparency and in support of access to clinical trial data.
Well in support of Responsible Access. Responsible essentially means that a researcher commits to the primacy of RCTs and statistical significance over an analysis of adverse events. It would not for example be responsible to claim that an SSRI causes suicide, a statin muscle damage or cognitive failure, or hypoglycemics cause hypoglycemia unless a trial has shown this to happen to a Statistically Significant extent and they never do.
This scenario suggests a variation on the old joke that Cricket is the English idea of fair-play eleven against one. Efforts to get at the raw data are just not Cricket.
Gunfight at the GSK Corral
A failure to be converted to a Responsible way of looking at the data underpins the stand-off between GSK and the RIAT team attempting to restore Study 329 to what it should have been. Study 329 is GSKs most famous clinical trial. RIAT stands for Restoring Invisible and Abandoned Trials (see Reading the RIAT Act).
The Doshi article along with the correspondence between GSK and the RIATers makes for eye-opening reading.
To recap, in 1998, SmithKline Beecham reviewed the final data from Study 329, a study begun in 1994, comparing Paxil, imipramine and placebo. They concluded that it demonstrated that paroxetine (Paxil-Seroxat) did not work for children. They decided they couldnt show the data to FDA but they could go ahead and publish the good bits of the study.
This ultimately led to a publication in 2001 in the leading journal in the field of child psychiatry, the Journal of the American Association of Child and Adolescent Psychiatrists, with an authorship line to die for. The first author was Marty Keller of Brown University. There were over twenty others.
The article states clearly that Paxil is safe and effective in children. Most doctors eyeballing it, and its distinguished authors and the journal in which it was published, would be much more inclined to use Paxil afterwards. That so many doctors in New York State in fact went on to prescribe so much Paxil to children led New York State to take a fraud action against GSK in 2004. This study was later at the center of the US Department of Justices case against GSK that resulted in a $3 Billion fine.
None of the apparent authors, it transpired, were authors in the sense people in the street would be likely to understand authorship. The real author Sally Laden appeared nowhere on the authorship line. The story behind the publication of 329 is laid out on Healthy Skepticism along with the efforts by Leemon McHenry and Jon Jureidini to get the authors, or the cuckolded institutions who lent their prestige to this ghostwritten article, or JAACAP, the journal in which it was published, to retract.
Which all refuse to do. And GSK as of a few weeks ago state that GSK does not believe the article is false, fraudulent or misleading (see GSK to RIATers).
Enter Stage Left
This is astonishing but there is another equally astonishing story to tell.
The temptation is for non-academics reading this to glaze over at the sight of theologians arguing about how many angels can dance on the head of a pin. But in fact those of you who have nothing to do with healthcare the Irresponsibles as it turns out were then and always are better placed to know when there is a problem. It was the doctors, ethicists and theologians, the Responsible Adults, who missed it. And if this is true of 329, it is likely to be true of everything else as well.
Study 329 began to unravel because a journalist, Shelley Jofre, working for BBCs Panorama, accidentally left to her own devices, begin to dig. She went to the American Psychiatric Association Meeting in Philadelphia in May 2002, clutching the Keller-Laden paper. She was interested to interview some of the authors. One of her questions was What is emotional lability? There was a surprising number of children in 329 who became emotionally labile whats this? she asked. No-one seemed to know.
At APA, she approached one of the 329 authors Neal Ryan, who gave a non-answer and quickly got in touch with GSK to let them know a journalist was asking questions.
A few weeks later in July and again in August, GSK send a dossier to FDA seeking approval for Paxil for children.
A few weeks after that, on October 7th, to coincide with World Mental Health day (October 10th), Newsweek hit the streets featuring a depressed teenager on the front cover and a strapline Teen Depression: 3 million kids suffer from it. What you can do. The message inside was that Prozac was already being marketing for children and Paxil and Zoloft were about to be. What you can do is get children on Prozac, Paxil and Zoloft.
Celebrating World Mental Health Day
Three days later, on October 10th, World Mental Health Day, and the 40th anniversary of the passage of the 1962 amendments to the Food and Drugs Act, FDA sent GSK a letter saying Paxil was approvable for kids.
Among other things, the letter notes that GSK had already told FDA that Study 329 showed that Paxil doesnt work for depressed children. FDA were happy to go along with GSKs suggestion that this should not be mentioned in the labeling of the drug. Given that the Study 329 publication majored on how effective Paxil was, it would have been inconvenient if the label said otherwise.
There are many notable things in this approvable letter. Perhaps the most interesting is FDA asking GSK to clarify just what emotional lability meant.
FDA have later spun this into a story that their reviewers detected there was an increase of emotional lability events in Study 329 that needed looking at. In fact this idea came on their radar after conversations between Jofre and third parties led to a visit to FDA on August 28th and a suggestion to FDA that they explore the issue of emotional lability.
FDA at the time had a few weeks to respond to GSKs request to market Paxil for children. Neither Jofre nor the third parties knew at the time that GSK were seeking pediatric approval for Paxil.
The Secrets of Seroxat The Perils of Paxil
On October 13th Jofres program, The Secrets of Seroxat aired on BBC. This led to one of the biggest responses the BBC had ever had to a Panorama program 65,000 calls and over 1000 emails.
Panorama had never repeated a topic before. Jofre and Panorama have revisited paroxetine and GSK a further four times each time demonstrating that when it comes to the blindingly obvious sometimes what you need is plain Curiosity rather than Responsibility.
In dealing with the RIAT team, GSK still insist there is nothing wrong with the Keller-Laden paper and show no interest to co-operate with setting the record right, even though the fraudulent version is still the only one on the public record. As such it is still being built into guidelines on the management of children who are depressed a trial that showed paroxetine doesnt work and leads to a statistically significant excess of suicidality (emotional lability).
When facing requests from others such as Peter Goetzsche to be Responsible (see GSKs Transparency and Access Journey), GSK have typically invited them to meet GSK experts in GSK House. This is more awkward with a RIAT team that is dispersed from Atlanta to Adelaide.
Its a lot more awkward with a journalist like Jofre, who asks herself along to GSK House with a list of questions in need of an answer.
Despite a haircut between programs, Jofre and Andy Bell produced a second Panorama program, in May 2003, Emails from the Edge that brought the walls of the Temple down. A few days after the second Panorama program, Britains MHRA blew a fuse and Seroxat-Paxil was on its way to being banned for children. To be continued
The moral of the story perhaps is GSK figure letting Responsible adults in to the Club is no problem, but they recognize that a motivated lay-person, particularly a woman spells trouble.
The new improved GSK CEO?
|January 23 2014, 5:50 PM |
Witty A: Report to the President
May 7, 2013
Editorial Note: This was to be the last in the Lasagna posts that began with Not So Bad Pharma, April Fool, Tragedy of Lou Lasagna, Empire of Humbug: Bad Pharma, Empire of Humbug 2, and Brand Fascism. But the series will continue into Marilyns Curse and When does Yes Mean No.
Faced with questions about the $3 Billion fine imposed on GSK is it just the cost of doing business? Andrew Witty snapped back:
Although corporate malfeasance cases end up looking very big, they often have their origin in just one or two people who didnt quite do the right thing. Its not about the big piece. The 100,000 people who work for GSK are just like you, right? Im sure everybody who reads the BMJ has friends who work for drug companies. Theyre normal people Many of them are doctors.
The current action against the European Medicines Agency (EMA) in the European Court is the first time Pharma has taken the regulator to a Supreme Court since the Panalba case (see Tragedy).
The 1962 amendments to the Food and Drugs Act required a determination of efficacy for any drugs marketed. In the case of drugs that had been licensed prior to 1962, FDA put in place a Drug Evaluation Study Initiative (DESI) to determine if they were likely to be efficacious. DESI convened panels of academics to adjudicate on these drugs.
FDA and many academic physicians, including Louis Lasagna, did not approve of combination products, whether antibiotics, analgesics or psychotropics of which there are plenty on the market. DESI recommended removing a large number of these. Lasagnas career changed forever when he came out against this recommendation (see Tragedy).
In 1969, DESI recommended removing Upjohns Panalba, a combination of tetracycline and novobiocin. By FDAs calculations Panalba was likely responsible for 12-15 deaths per year that wouldnt have otherwise happened if doctors had used tetracycline alone. At the time Panalba was making $18 million per year for Upjohn 12% of their income; $1 million per death. There was evidence that Upjohn knew of the risks the drug posed and in house evidence that Panalba was no more effective than tetracycline alone.
The options for Upjohn were:
- to pull the drug immediately from the market,
- to stop production but let doctors use up the supplies available,
- to continue to produce but stop marketing,
- to continue to produce and to promote until it was actually banned,
- to attempt to overturn FDAs decision using the Government and Judicial System
The company chose option 5. It involved the Secretary of State for Health in the Nixon Administration and pursued a legal action all the way to the Supreme Court.
When the details of the case were presented some years later to business management students in the University of Pennsylvania, Scott Armstrong found that none of his class supported Upjohn and all bar two of the 71 found Upjohns behaviour irresponsible.
But when he got students to role play the Upjohn Board and faced them with the decision to pull the drug or not, he found to his astonishment that 79% of respondents opted to take the same course of action as Upjohn and none withdrew the drug. This result has been widely replicated in different national groups with socialist Swedes behaving the same as capitalist Americans, and the idealistic young in just the same way as their cynical elders.
Debriefing the subjects and attempting to adjust the board and the circumstance to see if behaviour could be modified, Armstrong and others were left with the conclusion that it is generally accepted that the primary duty of Board members is to stockholders rather than to society at large. Board behaviour can be modified by appointing stakeholders but even then few Boards opt to remove Panalba from the market.
Armstrong modified the role play experiments by introducing an Upjohn safety officer who told the Board that the company did have hidden evidence supporting the complaints to no effect. In real life not even the death of the CEOs wife from suicide, from the Companys drug Prozac, has led to a decision to pull the drug or add warnings.
Putting people in a group where the unstated assumption is they will behave like a proper Board produces a situation which has commentators reaching for comparisons with the Milgram experiment where decent ordinary people in experimental settings can be induced to give life-threatening shocks to innocent strangers simply because they are asked to do so by the conductor of the experiment.
The only thing that appears to modify the likely behaviour of a Board is a threat of boycott that is if maintaining the drug on the market led to a disenchantment that led the company share price to fall.
While accepting Andrew Wittys suggestion that he and other employees of GSK are just like us, few of us can imagine being party to behaviours that warrant a $3 Billion fine. But from this study it seems we are more like him than he is like what we might like to think of ourselves.
GSKs proposals for transparency need to be read against this background is the company really offering to do the equivalent of remove their drugs from competition? Or are GSK just a little bit smarter than the competition?
When faced with the growing Fascism in healthcare, we can retreat to the wilder shores of conspiracy theory and claim the problems are down to the Germans, the Jews, or a Socialist cabal. Or we can attribute the problems to some evil people somewhere in pharmaceutical companies who break laws.
But if we accept that the Board of GSK and other companies are populated with people just like you and me, who are perhaps even less likely to break the law than you or I, the $3 Billion fine for GSK notwithstanding, then the problem must stem from and the remedy lie in the system.
Witty A: Report to the President on Changing the System
(Accounts of what led to the 2017 Amendments to the Food and Drugs Act vary wildly. Some say the Presidents first grandson was born with Tetralogy of Fallot linked to his daughters antidepressant intake. Conspiracy theories invoked Marilyns Curse. They noted things like the coincidence of initials between the unknown American Woman whose baby had a Tetralogy of Fallot and Andrew Witty (See AW and AW2). Others thought it was triggered by the fact that the previous President had to step down early because of cognitive failure linked to treatment with a Statin. Whatever the reason, Andrew Witty was recruited from GSK to become special advisor to the White House on how to change the system. Here is a précis of his option appraisal).
1). Regulation & Science
The licensing of drugs is a bureaucratic procedure that has nothing to do with science. As things stand, this procedure has enough of the appearances of science so that most doctors and patients taking part in it are fooled into thinking they are participating in scientific exercises when they are not.
Regulation is incompatible with science. Science seeks uncertainty, whereas regulation seeks to abolish uncertainty.
That Pharma does regulation not science should have been crystal clear in the legal action taken by Pharma against the EMA (2013), when Pharma took the option to stress that their data was simply the result of a regulatory exercise and regulators ordinarily maintain the confidentiality of submissions on products they regulate. This was the winning option.
There were doubts within Pharma about their ability to win using this argument while maintaining the illusion that companies do science. The argument was a bitter blow to the self esteem (amour propre) of FDA and EMA who liked to claim they based their actions on science. But medicine predictably noticed nothing.
2). The 2017 Amendments to the Food & Drugs Act
Regulation needs to be disentangled from science, but this cannot easily be done while the 1962 Amendments to the Food and Drugs Act contain an effectiveness criterion. This was a well-intentioned but unfortunate accident a simple solution to a complex problem that has made things worse.
In the new regulations to mark the 55th anniversary of the 1962 regulations the word effectiveness needs to be replaced by phrasing to the effect a drug should have a clear effect on a structure or function of the body. This falls back on language already in the regulations so should not be unduly problematic.
This would have the merit of making it a lot cheaper to develop new drugs. As a result, the cost of drugs would fall, more new drugs would be brought on the market and after marketing a lot of discoveries would be made. We could look forward to a new era of Wonder Drugs to rival the 1950s.
There would be comparatively little clinical trial data and campaigns like BMJ and the Cochrane collaboration to access the data would likely wither on the vine. It would be safe to appoint Peter Doshi and Tom Jefferson as data access Csars.
3). Evidence based Medicine
The determination of treatment effectiveness is critical to the rational practice of therapeutics. It cannot be left to industry; it should not involve industry. If undertaken properly by medicine, as for instance in trials like the Womens Health Initiative study of HRT or NIH studies of drugs from tolbutamide onwards, it would likely mean that a full appreciation of the risks and scale of the benefits to be obtained from a treatment would only be realized five years after the initial launch of a new compound.
4). Prescription-only Arrangements
Quite simply these need to be dismantled. Anyone who doesnt understand this doesnt understand marketing.
If prescription-only privileges are to be retained, only those who do understand the need to abolish them should be involved in any modification. There are a range of possible modifications such as requiring doctors to have a training post in a company marketing department before qualification. There is talk of rewarding them for reporting adverse events better to penalize them if they do not report them at a certain rate per year.
Another is to maintain certain drugs on prescription-only status such as chemotherapies for cancer where patients are particularly vulnerable and the treatments particularly toxic.
5). Abolish Medicine
Although companies are engaged in exercises that are simply bureaucratic, they have captured the appearances of science, more successfully than alchemists, homeopaths or others, and using these appearances they have been able to infect the body of scientific therapeutics. The insertion of what are essentially sophisticated adverts into the medical literature has triggered a Clinical Auto-Immune Deficiency reaction leading many doctors and scientists to attack those who question the results of ghostwritten articles that purport to represent studies whose data is withheld.
Physicians have had decades to find a way to get this cuckoos egg out of the nest of science. They could have based clinical practice only on investigations whose data is publicly available. They could have used the Human Rights of their patients as a lever it is not for instance possible for any doctor to prescribe any branded medicine with informed consent as things stand at present.
But they havent done anything like this. The branches of medicine linked to the prescribing of branded products are finished as a profession. They have no brand value. The market has now developed so that nurses, pharmacists, clinical psychologists and others could take over the role of prescribing and will be far less expensive.
If we believe in the market place, abolishing medicine will lead to a solution in that people and governments will realise that they need a set of experts who have brand value when it comes to good quality information on drugs and a new profession will be called into being.
There already was an effort in this respect by a Hungarian emigre to Canada, some ten years ago, to form a First Multinational Corporation of Physicians. This prototype could be dusted down, or another assembled.
Other physicians practicing in areas of medicine where branded products have had little penetration could be allowed to continue. One caveat here is that I have not considered whether areas of medicine that are heavy users of medical devices or medical procedures are as badly affected as mainstream medicine.
A further option might be a promotion of patient co-operatives. Groups like ACOR.org are making a significant difference to healthcare. They might find it far easier to work with nurse and pharmacist prescribers than with doctors.
One of the few things that might have influenced my behavior as CEO of GSK would have been a boycott. Record fines and even jail time are not deterrents. Almost everyone views these as a cost of doing business already. A jailed CEO might even boost share value.
We in GSK know that boycotts can hurt. The crisis over making ARVs available to South Africa for AIDs and the threat of a boycott was the only time our Board substantially altered its position.
Tied as they usually are to disease indications that dont exist, and surrogate markers, and produced as they are for bureaucratic purposes only, company efficacy data are frankly close to worthless and are not what companies have been trying to hide anyway. The key data have always been the adverse event data.The boycott would be aimed at getting companies to hand over Adverse Event data.
7). Boycott 2
In 1962, all of the wrong options from Kefauvers proposals were picked the effectiveness criterion, prescription-only arrangements, and controlled trials. The change he most favoured, a revision to the patent arrangements, was rejected.
Modifying patent arrangements is an indirect form of boycott that Congress should consider. Companies need to be rewarded but the current product patents reward them excessively for treatments that often shorten life and increase disability. There are alternate arrangements, such as process patents, that would make the various Panalbas less valuable and put a premium on diversifying the portfolio of compounds companies hold rather than have them dependent on a small number of blockbusters.
8). Access to Data
There are at present thousands or hundreds of thousands of drug trials that remain completely unregistered, where there are no issues of clinical confidentiality. These are studies undertaken in healthy volunteers normals. There is a compelling cases for ensuring these data are made fully available. Companies will need an amnesty for some of the abuses of people that will come to light as these studies come into view.
9). Independent Adverse Event Reporting
This is the key step. The steps companies have taken to prevent decent reporting, or to denigrate reporting when it happens, and to manage the perception of risk rather than risks themselves, make everything else they have done pale in comparison.
For instance companies supported the development of an FDA MedWatcher App in 2013. Widely applauded, this was in fact a way for companies to reduce the expense of maintaining a pharmacovigilance department, reduce their legal liabilities, and transform adverse events into anecdotes. Companies you see have a duty to follow up and decide if their drug caused the problem FDA dont have this duty.
But what was astonishing about all this was that pretty well everyone completely bought the idea that when it comes to working out whether a drug has caused a problem, a bureaucrat in FDA who is there because they dont like meeting patients, has never treated the condition you have and never used the drug you are on, would be better placed than a good team of doctor, pharmacist and informed patient perhaps in touch with other good teams, to work out whats going on.
If you can get people to buy this, who knows at a push they might even buy the idea the earth is flat.
Unless a patient organization gets involved in assembling real-time data and both doctors and patients combine to put risk mitigation programs in place, none of the other changes will work.
The bottom line is the average drug has at least 100 effects. Using clinical trials we have been hugely successful in hypnotizing doctors and patients to focus on one effect and to miss the other 99. This pharmagnosia is a major driver of Pharmageddon (See Marilyns Curse). If the climate change encroaching on healthcare is to be rolled back, we need to manage pharmagnosia.
We can still have a market solution but it needs to be a Comparative Safety market rather than a Comparative Efficacy market.
Will we get fooled again? "GlaxoSmithKline and access to data"
|January 23 2014, 6:36 PM |
(article dated November 2012)
"Wont get fooled again? GlaxoSmithKline and access to data
Meanwhile GlaxoSmithKline have been winning kudos after their CEO Andrew Witty promised to make the data from their clinical trials available. This offer has been welcomed glowingly by the BMJ, who civilly steered clear of mentioning the fraud action for withholding trial data that led to a $3 Billion fine for GSK.
Over a decade ago before merging with SmithKline, Glaxo-Wellcome made a comparable offer of transparency. Perhaps good Glaxo has got the upperhand on the more worldly SmithKline lawyers sometimes put GSKs aberrations down to legacy issues. But there are wrinkles this is not unfettered access. A panel set up by the company will vet applications to access the data. The BMJ slid over this.
Maybe good Glaxo has got the upper hand but perhaps the BMJ should have resisted the temptation to gush. Even if they were just being civil, the gush factor will lead many who dont understand the way the English read between lines to think that industry have undergone a Damascene conversion. GSKs gift is a far more effective form of resistance than Roches..."
The 'Damascene conversion' came only a few months after this:
"Glaxo in $3 Billion Settlement
Updated July 3, 2012 12:01 a.m. ET
Under the deal, which requires court approval, Glaxo will plead guilty to criminal charges involving three drugsthe antidepressants Paxil and Wellbutrin and the diabetes drug Avandia..."
New, improved GSK? Or just cleverer (and more experienced) than most in turning a reputation of criminality and disregard for the safety of children and adults around in the hope that we are easily taken in?
In the meantime, what have they done to seek out and help damaged children from the hidden negative study 329 (paroxetine) or to help bereaved parents of children lost in or after those trials?
And what steps have they taken to protect children?
None at all as far as I can tell.
and their $3 billion settlement of criminal & civil charges less than 2 years ago
|January 23 2014, 6:50 PM |
"Pharmaceutical maker GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability over drug marketing and other issues, the U.S. Department of Justice said Monday...."
As mentioned in the message directly above
Transparency? Not even an apology for the harm they have done and are still doing. And
|January 23 2014, 7:01 PM |
not even a word to the world to let GPs know that their drugs actually do cause some horrific - sometimes fatal - adverse effects: so that at least people now and onward can get help where possible for adverse drug effects.
Until they at least do that, how can we ever trust them again?
No admission to the people that the SAD campaign was simply a marketing tactic
|January 23 2014, 7:24 PM |
successfully designed to get doctors and patients to believe there was a new 'disease epidemic' which needed the drug paroxetine (Study 329 again) being taken en masse.
All these 'little' things that have harmed so many and caused the death of some, we need GSK to announce (as loudly as they marketed their mythical disease epidemic and their [toxic] drug treatment) to ensure the message gets out clearly far and wide) and to EXPLAIN THAT SOCIAL ANXIETY DISORDER WAS A MARKETING TACTIC undertaken by their Public Relation experts Cohne and Wolfe.
First, you market the disease... then you push the pills to treat it
"Brendan I Koerner on the ugly truth about doctors, PR firms and drug companies Brendan I Koerner The Guardian
, Tuesday 30 July 2002 16.24 BST
Word of the hidden epidemic began spreading in spring last year. Local news reports around the United States reported that as many as 10 million Americans suffered from an unrecognised disease. Viewers were urged to watch for the symptoms: restlessness, fatigue, irritability, muscle tension, nausea, diarrhoea, and sweating, among others. Many of the segments featured soundbites from Sonja Burkett, a patient who had finally received treatment after two years trapped at home by the illness, and from Dr Jack Gorman, an esteemed psychiatrist at Columbia University.
The disease was generalised anxiety disorder (GAD), a condition that, according to the reports, left sufferers paralysed with irrational fears. Mental-health advocates called it "the forgotten illness". Print periodicals were awash with stories of young women plagued by worries over money and men. "Everything took 10 times more effort for me than it did for anyone else," one woman told the Chicago Tribune. "The thing about Gad is that worry can be a full-time job. So if you add that up with what I was doing, which was being a full-time achiever, I was exhausted, constantly exhausted."
The timing of the media frenzy was no accident. On April 16 2001, the US food and drug administration (FDA) had approved the antidepressant Paxil, made by British pharmaceutical giant GlaxoSmithKline, for the treatment of Gad. But it was a little-known ailment; according to a 1989 study, as few as 1.2% of the US population merited the diagnosis in any given year. If GlaxoSmithKline hoped to capitalise on Paxil's newapproval, it would have to raise Gad's profile.
That meant revving up the company's public-relations machinery. The widely featured quotes from Burkett were part of a "video news release" the drug maker had distributed to TV stations around the country; the footage also included the comments of Gorman, who has frequently served as a paid consultant to GlaxoSmithKline. On April 16 - the date of Paxil's approval - a patient group called freedom from fear released a telephone survey which revealed that "people with Gad spend nearly 40 hours per week, or a 'full-time job,' worrying". The survey mentioned neither GlaxoSmithKline nor Paxil, but the press contact listed was an account executive at Cohn & Wolfe, the drugmaker's PR firm.
The modus operandi of GlaxoSmithKline - marketing a disease rather than selling a drug - is typical of the post-Prozac era. "The strategy [companies] use - it's almost mechanised by now," says Dr Loren Mosher, a San Diego psychiatrist and former official at the national institute of mental health. Typically, a corporate-sponsored "disease awareness" campaign focuses on a mild psychiatric condition with a large pool of potential sufferers. Companies fund studies that prove the drug's efficacy in treating the afiction, a necessary step in obtaining FDA approval for a new use, or "indication". Prominent doctors are enlisted to publicly affirm the malady's ubiquity, then public-relations firms launch campaigns to promote the new disease, using dramatic statistics from corporate-sponsored studies. Finally, patient groups are recruited to serve as the "public face" for the condition, supplying quotes and compelling stories for the media; many of the groups are heavily subsidised by drugmakers, and some operate directly out of the offices of drug companies' PR firms.
The strategy has enabled the pharmaceutical industry to squeeze millions in additional revenue from the blockbuster drugs known as selective serotonin reuptake inhibitors (SSRIs), a family of pharmaceuticals that includes Paxil, Prozac, Zoloft, Celexa, and Luvox. Originally approved solely as antidepressants, the SSRIs are now prescribed for a wide array of previously obscure afflictions - Gad, social anxiety disorder, premenstrual dysphoric disorder, and so on. The proliferation of diagnoses has contributed to a dramatic rise in anti-depressant sales, which increased eightfold between 1990 and 2000.
For pharmaceutical companies, marketing existing drugs for new uses makes perfect sense: a new indication can be obtained in less than 18 months, compared to the eight years it takes to bring a drug from the lab to the pharmacy. Managed-care companies have also been encouraging the use of medication, rather than more costly psychotherapy, to treat problems such as anxiety and depression.
But while most health experts agree that SSRIs have revolutionised the treatment of mental illness, a growing number of critics are disturbed by the degree to which corporate-sponsored campaigns have come to define what qualifies as a mental disorder and who needs to be medicated.
When Paxil hit the market in 1993, the drug's manufacturer, then known as Smith-Kline Beecham, lagged far behind its competitors. Eli Lilly's Prozac, the first FDA-approved SSRI, had already been around for five years, and Pfizer had beaten Smith-Kline to the punch with Zoloft's debut in 1992. With only a finite number of depression patients to target, Paxil's sales prospects seemed limited. But SmithKline found a way to set its drug apart from the other SSRIs: it positioned Paxil as an anti-anxiety drug - a latter-day Valium - rather than as a depression treatment.
SmithKline was especially interested in a series of minor entries in the diagnostic and statistical manual of mental disorders (DSM), the psychiatric bible. Published by the American psychiatric association since the 1950s, the DSM is designed to give doctors and scientists a common set of criteria to describe mental conditions. Entries are often inuenced by cultural norms (until 1973, homosexuality was listed as a mental disorder) and political compromise: it is written by committees of mental-health professionals who debate, sometimes heatedly, whether to include specific disorders. The entry for GAD, says David Healy, a scholar at the college of medicine at the University of Wales and author of the 1998 book The Antidepressant Era, was created almost by default: "Floundering somewhat, members of the anxiety disorders subcommittee stumbled on the notion of generalised anxiety disorder," he writes, "and consigned the greater part of the rest of the anxiety disorders to this category."
Critics note that the DSM process has no formal safeguards to prevent researchers with drug-company ties from participating in decisions of interest to their sponsors. The committee that recommended the Gad entry in 1980, for example, was headed by Robert L Spitzer of the New York state psychiatric institute, which has been a leading recipient of industry grants to research drug treatments for anxiety disorders.
SmithKline's first forays into the anxiety market involved two fairly well-known illnesses - panic disorder and obsessive-compulsive disorder. Then, in 1998, the company applied for FDA approval to market Paxil for something called social phobia or "social anxiety disorder" (SAD), a debilitating form of shyness the DSM characterised as "extremely rare".
Obtaining such a new approval is a relatively simple affair. The FDA considers a DSM notation sufficient proof that a disease actually exists and, unlike new drugs, existing pharmaceuticals don't require an exhaustive round of clinical studies. To show that a drug works in treating a new disease, the FDA often accepts in-house corporate studies.
With FDA approval for Paxil's new use virtually guaranteed, SmithKline turned to the task of promoting the disease itself. To "position social anxiety disorder as a severe condition", as the trade journal PR News put it, the company retained the New York-based public-relations firm Cohn & Wolfe. (Representatives of GlaxoSmithKline and Cohn & Wolfe did not return my phone calls.)
By early 1999 the firm had created a slogan, "Imagine Being Allergic to People", and wallpapered bus shelters nationwide with pictures of a dejected-looking man vacantly playing with a teacup. "You blush, sweat, shake-even find it hard to breathe," read the copy. "That's what social anxiety disorder feels like." The posters made no reference to Paxil or SmithKline; instead, they bore the insignia of a group called the social anxiety disorder coalition and its three non-profit members, the American psychiatric association, the anxiety disorders association of America, and freedom from fear.
But the coalition was not a grassroots alliance of patients in search of a cure. It had been cobbled together by SmithKline Beecham and Cohn & Wolfe handled all media inquiries on behalf of the group.
The FDA's advertising regulations also helped the Cohn & Wolfe strategy. "If you are carrying out a disease-awareness campaign, legally the company doesn't have to list the product risks, notes Barbara Mintzes, an epidemologist at the University of British Columbia's centre for health services and policy research. Because the "Imagine Being Allergic to People" posters did not name a product, they did not have to mention Paxil's side effects, which can include nausea, decreased appetite, decreased libido, and tremors.
Cohn & Wolfe's strategy did not end with posters. The firm also created a video news release, a radio news release, and gave journalists a press statement stating that SAD "affects up to 13.3% of the population," - one in eight Americans -and is "the third most common psychiatric disorder in the United States, after depression and alcoholism." By contrast, the diagnostic and statistical manual cites studies showing that between 3-13% of people may suffer the disease at some point in their lives, but that only 2% "experience enough impairment or distress to warrant a diagnosis of social phobia".
Cohn & Wolfe also supplied journalists with eloquent patients, helping to "put a face on the disorder", as account executive Holly White told PR News. Among the patients most frequently quoted in stories about social anxiety disorder was a woman named Grace Dailey, who had also appeared in a promotional video produced by Cohn & Wolfe.
Also on that video was Jack Gorman, the Columbia University professor who would later make the rounds on Paxil's behalf during the GAD media campaign, appearing on numerous television shows, including ABC's Good Morning America.
Gorman was not a disinterested party in Paxil's promotion. He has served as a paid consultant to at least 13 pharmaceutical firms, including SmithKline Beecham, Eli Lilly, and Pfizer. Another frequent talking head in the SAD campaign, Dr Murray Stein of the University of California at San Diego, has also served as a Smith-Kline consultant, and the company funded many of his clinical trials on SAD.
Cohn & Wolfe's campaign on SAD paid immediate dividends. In the two years preceding Paxil's approval, fewer than 50 stories on social anxiety disorder had appeared in the popular press. In May 1999, the month when the FDA handed down its decision, hundreds of stories about the illness appeared in US publications and television news programmes, including the New York Times, Vogue, and Good Morning America. A few months later, Smith-Kline launched a series of ads touting Paxil's efficacy in helping SAD sufferers brave dinner parties and public speaking. By the end of last year, Paxil had supplanted Zoloft as the nation's number-two SSRI, and its sales were virtually on par with those of Eli Lilly's Prozac. (Neither Prozac nor Zoloft has anapproval for SAD.)
The success of the Cohn & Wolfe campaign didn't escape notice in the industry: trade journals applauded GlaxoSmithKline for creating "a strong anti-anxiety position" and assuring a bright future for Paxil. Increasing public awareness of SAD and other disorders, the consulting firm Decision Resources predicted last year, would expand the "anxiety market" to at least $3bn by 2009.
· This is an edited excerpt from an article in Mother Jones magazine "
Does GSK know how many people have suffered harm since the campaign, and how many children and adults have died because of the campaign?
Time for the truth and for some GENUINE transparency, GSK.
In a world of prescription drug misery, one clear light shines out:
|January 23 2014, 7:37 PM |
The light of the collectively named 'Big Pharma'.
The colour of the light is RED.
Time for GSK to 'save the children' damaged by paroxetine
|January 29 2014, 10:38 PM |
(of which there are many) and to apologise for those deaths.
Glaxo and its transparency commitment
|February 17 2014, 12:19 PM |
"Glaxo and its transparency commitment
By Ed Silverman
For the past year, GlaxoSmithKline has vowed to usher in a new era of transparency by creating a system to disclose detailed clinical trial data. This widely publicized move has been hailed by many critics of the pharmaceutical industry who have accused drug makers of deliberately concealing vital information that should be accessible to others in order to confirm safety and effectiveness.
Now, though, a group of researchers is putting the drug maker to the test by requesting detailed data for an infamous study of its Paxil antidepressant, but are squabbling with the drug maker over information being sought. In the process, the dispute is raising questions about whether Glaxo complied with a 2004 consent order with the New York State Attorney General to publicly disclose the Paxil trial data.
At issue is data for Study 329. Glaxo participated in preparing, publishing, and distributing what U.S. authorities called a misleading medical journal article because the results reported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study actually failed to make the case. The trial missed its endpoints and also figured in a ghostwriting controversy.
For more than a decade, the study has haunted Glaxo after it became known that suicide risks in what was one of the best-selling antidepressants had been minimized. The episode, which led Glaxo to the 2004 consent order, factored into the $3 billion settlement with the U.S. Department of Justice last year for illegal promotion and pricing activities. For its part, Glaxo maintains it has fully complied with the order.
However, a loose-knit group of researchers led by Jon Jureidini, a child psychiatrist at the Womens and Childrens Hospital in Adelaide, Australia, and a professor in psychiatry and pediatrics at the University of Adelaide, is haggling with Glaxo over certain data referred to in the consent order. They maintain the drug maker has balked at their request and raised questions about its commitment to releasing data.
The tussle underscores the ongoing tension over the extent to which certain data notably, anonymous patient-level data can or should be released. Recently, a group that includes academics and consultants some of whom are affiliated with the Multi-Regional Clinical Trials Center at Harvard University suggested an independent panel should be created. And in a recent essay in The Lancet, Glaxo R&D chief Patrick Vallance and Iain Chalmers one of the founders of the Cochrane Collaboration argue that open access to this detailed data poses many risks.
But according to the researchers, Glaxo is using this as a smokescreen. The company has come up with the perfect way to appear to be transparent while making actual access to data close to impossible, David Healy, a psychiatry professor at Bangor University in Wales and frequent industry critic who wrote Let Them Eat Prozac a book about the marketing of antidepressants tells us. The group has been writing to (Glaxo CEO) Andrew Witty et al and getting nowhere really.
The researchers plan to provide the correspondence with Glaxo to BMJ, one of the sponsors of the AllTrials campaign that was launched earlier this year to prod drug makers into releasing trial data. In their view, public pressure is needed to convince drug makers to release clinical trial data. For instance, Roche agreed to release data for the companys Tamiflu treatment after its correspondence with researchers was published in BMJ.
I dont think its a coincidence that the only two pharmaceutical companies which have got a policy on access to previously confidential trial data are Roche and GSK. In my mind, this shows the power of the media and academia, BMJ and the Cochrane group if used in a responsible and balanced way, says Tom Jefferson, an epidemiologist with the Cochrane Collaboration, who tussled with Roche and is advising the researchers who are seeking Study 329 data. The BMJ is a can opener it exposed this to the world.
By publicizing the dispute, the researchers hope to demonstrate that Glaxo is failing to live up to its commitments. Jureidini, by the way, also sought to have Journal of the American Academy of Child and Adolescent Psychiatry, which published Study 329 in 2001, disavow the study and issue a retraction, but the journal has repeatedly refused to do so.
Although the researchers have not yet released the details of their correspondence with Glaxo, one issue they have raised, and which some describe as central to the dispute, is the extent to which the drug maker is making all data available in accordance with the consent order. And this apparently hinges on the definitions of various terms used to describe the requirements Glaxo must follow.
For instance, page 7 of the order says, beginning in February 2005, Glaxo must provide public access to the clinical study reports of Paxil as a treatment for major depressive disorder in the pediatric population for a 10-year period. An attached document defines clinical study report as including all data. And data is defined as all the results and outcome measurements obtained from a clinical study.
The researchers note the page on the Glaxo Website housing 329 Study data lists several appendices, but one Appendix H is just four pages and lists only patient identification numbers found in case report forms for patients who experienced serious adverse events that led to withdrawal from the trial. This information was reported to regulators. One page has a table with the intent-to-treat population.
The researchers are questioning whether this omission violates the 2004 consent order. They point out that Glaxo has already redacted certain information that was contained in the other appendices that are publicly posted, and believe that the drug maker should do the same for Appendix H, rather than, essentially, not post any of the information.
We asked the New York State Attorney General whether this constituted a violation and a spokeswoman would not address the specifics raised by the researchers, but tells us that the office is continually monitoring compliance and, in this instance, continues to monitor the Glaxo consent order. She adds that researchers are free to file complaints if they believe a violation has occurred.
For its part, Glaxo maintains that its newly launched Website contains the necessary data for the researchers to analyze Study 329, although the site does not publicly disclose case report forms, which are the files that were used to collect data from each patient, because these contain information (such as names) that can readily identify the patients concerned, a Glaxo spokeswoman explains.
And she adds that the press release from the New York Attorney General, which contains links to the consent order and related documents, refers only to the clinical trial register. And the CTR, she explains, posts only summaries and nothing with the level of detail that is found clinical study reports or clinical report forms.
The clinical study reports for Study 329 already are posted on our Website; the data that Study 329 was set up to obtain is contained in the CSRs and the associated appendices posted on our website; and the anonymized patient-level data is available through the online system we launched in May, the spokeswoman writes us.
As you know, any request to that site is reviewed by a panel at arms length from GSK and researchers who have a legitimate trial question and protocol, and commit to publishing their results, are likely to be granted access to the anonymized electronic data they request, she continues. We believe that with the information already available on our website and if he submits a request through our online system to access the patient-level data, Prof. Jureidini will have what he needs to complete his new analysis.? We have fulfilled our commitment to public access by posting on our website the Clinical Study Reports and associated Appendices which contain the results and outcome measurements from the studies. For access to anonymized patient level data in an electronic, analyzable database, we require a research proposal to be submitted which is reviewed by an Independent Review Panel. Where approved, access is provided in a secure website, she concludes.
In other words, a great deal of parsing is under way. And much of this hinges on the understandings that occurred at the time the consent order was reached, as well as the extent to which Glaxo can or should provide redacted information referring to patient-level data.
Posted: December 2013 "
In the meantime, Corporate Trade Agreements (inc. Big Pharma) are Crushing Democracy
|February 17 2014, 1:07 PM |
Big Pharma involved at the same time as they're supposedly aiming towards clinical transparency.
"Food Wars: Corporate Trade Agreements Overshadowing Democracy
"...Crushing Local Democracy with Corporate Trade Agreements
Fearing the spread of citizen activism, ballot initiative and community rights ordinances, major food corporations and biotech firms, joined by Big Pharma, multinational banks, and the fossil fuel industry, have been single-mindedly lobbying for approval of several new sweeping, secretly-negotiated international trade agreements, the Trans-Pacific Partnership (TPP), and the Trans-Atlantic Free Trade Agreement (TAFTA). These agreements, full of anti-consumer and anti-worker provisions, also grant multinational corporations the sovereign right to nullify local, state and national food labeling, food safety, Fair Trade, Buy Local, labor rights, indigenous, and environmental protection laws. In an unprecedented demonstration of North American and international solidarity and online/grassroots action, a broad coalition of anti-GMO, environmental, Fair Trade, and labor activists seem to have derailed the TPP and TAFTA, at least for the moment, preventing President Obama from ramming the TPP through Congress, utilizing so-called Fast Track authority..."
End of extract - read full article at link.
'Extreme Secrecy' of the Trans-Pacific Partnership (TPP)
|February 17 2014, 1:30 PM |
"Legislators from seven countries call for release of Trans-Pacific Partnership text
| February 13, 2014
Dozens of legislators from seven of the 12 countries negotiating the U.S.-led Trans-Pacific Partnership trade agreement took the unprecedented step this week of calling for the full TPP text to be released publicly before it is signed. The open letter reads simply:
We, the undersigned legislators from countries involved in the negotiation of the Trans-Pacific Partnership Agreement, call on the Parties to the negotiation to publish the draft text of the Agreement before any final agreement is signed with sufficient time to enable effective legislative scrutiny and public debate.
Jane Kelsey, a prominent New Zealand TPP critic and professor at the University of Auckland, said of the joint letter: "The trade ministers from the TPP parties have backed themselves into a corner with their extreme secrecy. That position is now untenable."
The impressive showing of legislative opposition to TPP secrecy comes just 10 days before another secret round of negotiations is set to begin in Singapore (February 22-25) and days ahead of so-called intersessional meetings of TPP negotiators from February 17-21. One industry source told Inside U.S. Trade this week there are low expectations for the meetings but in January a Mexican trade official told the same publication the talks could wrap up by the end of April.
In Canada, the legislators' letter was signed by Don Davies, the NDP international trade critic, and Green Party Leader Elizabeth May.
"The TPP covers issues that affect many areas of Canada's economy and society -- including several policy areas that have never been subject to trade agreements before," said Davies of why he endorsed the letter. "In the interest of transparency and accountability, trade negotiation documents must be released to the public and in a meaningful way."
The Conservative government of Stephen Harper has said almost nothing about the TPP publicly or to the media, and will not release a cost-benefit assessment of the deal to the parliamentary trade committee. Any criticism of the deal, or the similarly intrusive and secretive Canada-European Union Comprehensive Economic and Trade Agreement, has been dismissed without meaningful arguments as "anti-trade."
The open letter followed approaches to senior politicians from Australia, Canada, Japan, Malaysia, Mexico, New Zealand and Peru who had expressed concern about the lack of transparency in the TPP negotiations. Other signatories include the Vice-President of Peru, the trade spokesperson for Australia's Green Party, and several former Cabinet ministers from Japan.
But the letter is only the latest in a stream of calls by legislators in TPP countries for release of the texts over the past year. It also comes only a week after fair trade rallies were held in more than 50 communities across North America as part of an Intercontinental Day of Action Against the TPP and Corporate Globalization (see video). U.S. President Obama is feeling the heat even from within the Democratic party, which is not inclined to give him the "fast track" powers the administration feels it will need to pass the TPP with minimal delays in Congress.
As Kelsey explained, "The Australian Labor Party succeeded with a motion in the Senate last December calling for the text of the TPP and all other free trade agreements to be tabled in Parliament at least 14 days before they are signed. The Liberal government has refused."
The New Zealand government also rejected a Labour Party motion asking:
That the House call on the New Zealand Government to publish the text of the Trans-Pacific Partnership Agreement before any final agreement is signed, with sufficient time to enable effective legislative scrutiny and public debate; either when it is made public by the United States Congress, or not less than 14 days prior to its signing in New Zealand; whichever is the earlier.
"Legislators from other countries have gone considerably further, demanding the release of the draft texts to allow them to do their job as legislators, open the process to expert analysis and democratic debate, and remove the reliance on leaked texts," said Kelsey in her statement on the joint letter.
"In December, 34 deputies and 15 senators from Chile's Parliament called on the President to halt the negotiations and make them transparent. Many belong to the party that will become the government in March... Members of the US Congress have issued a constant stream of letters objecting to the secrecy and seeking release of the draft texts."
The letter and related documents can be found at www.tppmpsfortransparency.org, a website co-hosted by development agency Oxfam International and Article 19, an international NGO that campaigns for freedom of expression and transparency.
For more on The Council of Canadians' campaign against the TPP, visit our website here "
|Just as Big Industry inc Big Pharm likes it .|
'Mainstream Media Silent on Dangerous Trans-Pacific Partnership'
|February 17 2014, 1:47 PM |
"Tuesday, 11 February 2014 18:30
Mainstream Media Silent on Dangerous Trans-Pacific Partnership
Despite the many unconstitutional provisions purportedly contained in the Trans-Pacific Partnership (TPP) agreement, the mainstream media has ignored the subject almost entirely.
A survey of television news coverage of the TPP reveals that a:
transcript search of CBS Evening News with Scott Pelly, ABC's World News with Diane Sawyer, and NBC Nightly News with Brian Williams from August 1, 2013 through January 31, 2014 found no mention of the Trans-Pacific Partnership. The TPP received one mention on PBS' Newshour, when Doug Paal of the Carnegie Endowment for International Peace argued that approving the TPP would improve relations with Asian nations.
The 24-hour cable news channels have been almost as silent. The report indicates that the three largest cable networks CNN, MSNBC, Fox News covered the ongoing negotiations 33 times during their evening programming. The overwhelming majority of these mentions (32) originated on MSNBC and aired during The Ed Show.
That the pro-Establishment media should ignore a threat to the Constitution is no surprise, particularly since their political patrons do likewise. The problem with the information embargo on the TPP is that there are millions of Americans who still rely on the so-called mainstream media for their news.
Perhaps this is the precise purpose behind the decision to keep the TPP out of the headlines and off the nightly news.
The Fast Track to Tyranny
Forbes reports, for example, that only President Obama can close the deal on the TPP. Part of that includes persuading Congress to fast track negotiation of the TPP, in the form of a Trade Promotion Authority (TPA) bill.
The TPA is a tool that the president demands be in the U.S. trade representatives bag when he sits down with his colleagues from the other TPP participants. Again, from Forbes:
TPA or fast track is essential for the President to complete negotiations. Negotiators for our trading partners would be foolish to sign off on a treaty unless they knew that the Congress could not amend it.
A TPA bill would allow the Trans Pacific Partnership Treaty, said to be in its final stages, to be completed and ratified. In addition to its trade and economic benefits, TPP is the most prominent piece of the Obama pivot to Asia, his attempt to exercise more leadership in the area. TPP is supposed to lead the region to our version of open, reciprocal trade rather than have the region move toward the Chinese mercantilist model.
That would be a little more believable were it not for the fact that the president himself has entertained the inclusion of China in the TPP.
Obama Seeks Chinese Participation in TPP
As The New American reported, President Obama has signaled that he would entertain the idea of the Chinese communist governments partnership in the bloc.
Now, word from Tawainese media reveals mainland China's increasing interest in getting in on the TPPs destruction of American economic prosperity.
After citing South Koreas interest in joining the trade pact negotiations, the China Post reports:
Now, China is also indicating interest. Foreign Minister Wang Yi, while outlining diplomatic priorities for 2014, said that economic diplomacy would be a major focus of Chinese diplomacy in the new year and that China will face the member states of the Trans-Pacific Partnership talks with an open attitude, as well as other regional or cross-region FTA initiatives.
President Obamas fascination with intertwining the economic welfare of the United States with China is perhaps one reason a recent commentator called the TPP another disaster from a proven liar.
Perhaps it is this sinister ulterior motive that has prompted the president to steadfastly protect the secrecy that has shrouded the drafting of the TPP treaty from the beginning.
Secret Surrender of Sovereignty
In November 2013, portions of the TPP draft agreement published by WikiLeaks contained sketches of President Obamas plans to surrender American sovereignty to international tribunals.
Another WikiLeaks disclosure in January revealed that the president was attempting to surrender sovereignty over U.S. environmental policy to international bureaucrats interested in lowering those standards to mirror those of our TPP partner nations.
U.S. copyright laws, Internet freedom, and web-based publishing would also be obliterated by the TPP, and, although it hasnt been widely reported, the TPP would give the global government sweeping surveillance powers, as well.
Although the American people (and the people of all nations involved in the pact) are prevented from seeing or commenting on the treaty being ostensibly negotiated on their behalf, multinational corporations have seats at the trading table.
While the TPP grants corporate giants such as Walmart and Monsanto the power to bypass Congress and the courts, the elected representatives of the American people are kept from even seeing the draft version of the agreement.
As with the multitude of similar trade pacts the United States has formed, the ultimate aim of the TPP is the creation of a regional super government, thus the stonewalling of federal lawmakers who dare seek to assert some sort of oversight.
Economic and Political Integration as a Step Toward Global Government
In the case of the TPP, the zone would be called the Free Trade Area of the Asia Pacific (FTAAP). Members of the proposed free trade bloc include all the current TPP participants: Malaysia, Singapore, Japan, Vietnam, Brunei, Australia, New Zealand, Peru, Mexico, Chile, Canada, and the United States. The regional trading partnership is intended to establish a comprehensive free trade agreement across the region.
The ultimate goal of the TPP isnt just the creation of an FTAAP, though. Supporters of the deal insist that the TPP is a trade agreement designed to achieve broad liberalization and a high degree of economic integration among the parties.
Integration is a word that is painful to the ears of constitutionalists and those unwilling to surrender U.S. sovereignty to a committee of globalists who are unelected by the American people and unaccountable to them. Integration is an internationalist tool for subordinating American law to the globalist bureaucracy at the United Nations.
Economic and political integration will push the once independent United States of America into yet another collectivist bloc that will facilitate the complete dissolution of our country and our states into no more than subordinate outposts of a one-world government.
In an article examining the devastating effects of the TPP, William Jasper, senior editor of The New American, identified the end game for these globalists and their secretly planned trade pacts. Wrote Jasper:
The architects and promoters of the TPP and FTAAP frequently point with admiration to the integration process of the European Union (EU) as the model they would like to see implemented for the Asia-Pacific rim nations. As with the Transatlantic Trade and Investment Partnership (TTIP), the Trans-Pacific Partnership has been designed to follow the EU example of relentless widening and deepening, constantly eroding national sovereignty, while building transnational governance that is not restrained by the checks and balances of national constitutions.
Equally significant is that 600 industry lobbyists and "advisors," as well as unelected trade representatives, are at the table, while representatives from the public at large and businesses other than huge monopolies, are conspicuously absent.
Each of the partners to the pact, including foreign corporations, would be exempted from abiding by American laws governing trade disputes. Moreover, the sovereignty of the United States and the Constitutions enumeration of powers would once again be sacrificed on the altar of global government by subordinating U.S. laws passed by duly elected representatives of the people to a code of regulations created by a team of transnational bureaucrats.
Americans who study the subject realize that the redrawing of national boundaries and domestic legal processes being carried out in secret by the globalists sitting around the TPP negotiating table is an attack on American laws, American courts, American freedom of expression, American sovereignty, and the American Constitution.
If television news has its way, however, millions of Americans whose lives will be substantially changed by the TPP will never hear a word about it.
Can't help feeling that the 'new transparency' interest shown by some big members of big pharma is merely a distraction until the TPP is in place - which appears to then give industries the upper hand in legislation.
|& NOT open for debate or amendment|
TPP and TTIP enshrine rights of Corporations under International Law
|February 17 2014, 2:03 PM |
"The Trans Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TTIP) enshrine the rights of Corporations under International Law, restricting future governments from overturning the changes through fear of costly legal action. They are the largest trade agreements in history, and yet are not open for review, debate or amendment by national parliaments or the public.
The Trans Pacific Partnership (TPP)
The agreement between the US and 11 other Pacific Rim countries representing 40% of global GDP, has been under negotiation for three years. The US, Canada, Australia, New Zealand, Japan, Mexico, Malaysia, Chile, Singapore, Peru, Vietnam, and Brunei will shortly be signing up to the TPP, with only a handful of people in each nation aware of the content of the deal.
It was recently revealed that only three individuals in each TPP nation have been given full access to the agreement, while 600 trade advisors, those are corporate lobbyists from corporations such as Monsanto, Chevron, Haliburton and Walmart have been granted access.
In fact, if it were not for WikiLeaks, we would still be unaware of the contents of the TPP. In mid-November, WikiLeaks published a draft chapter of the agreement and the reasons for secrecy became clear. This agreement tips the scales in the balance of power between Corporations and the State tipping them firmly in favour of corporations.
The section of the agreement published by Wikileaks focuses on intellectual property, a chapter it chose due to its wide-ranging effects on medicines, publishers, internet services, civil liberties and biological patents. The subsections of the chapter make agreements relating to patents (who may produce goods or drugs), copyright (who may transmit information), trademarks (who may describe information or goods as authentic) and industrial design. And as WikiLeaks state in their press release:
The longest section of the Chapter Enforcement is devoted to detailing new policing measures, with far-reaching implications for individual rights, civil liberties, publishers, internet service providers and internet privacy, as well as for the creative, intellectual, biological and environmental commons. Particular measures proposed include supranational litigation tribunals to which sovereign national courts are expected to defer, but which have no human rights safeguards. The TPP IP Chapter states that these courts can conduct hearings with secret evidence. The IP Chapter also replicates many of the surveillance and enforcement provisions from the shelved SOPA and ACTA treaties.
All, in just one 30,000 word chapter of this agreement.
However, the TPP is the forerunner for its sister project the EU/US Trade and Investment Partnership (TTIP). This next agreement rolls out the principles of the TPP across the EU and the UK.
The Transatlantic Trade and Investment Partnership
The TTIP is a secret agreement, negotiated behind closed doors by anonymous representatives. This agreement will deliver the corporate privilege of TPP to the EU and UK, with the same lack of democratic scrutiny.
The EU announced earlier this year that a High Level Working Group on Jobs and Growth, U.S. Trade Representative Ron Kirk and EU Trade Commissioner Karel De Gucht, would research and report on plans to proceed with negotiations for the TTIP. They did not produce a list of the membership of this group. All subsequent reports failed to mention authorship, contributors, or even the names of those reviewing or approving the reports for release. Research and campaign organising Corporate Europe Observatory issued a Freedom of Information request to garner this information and were told there is no document containing the list of authors of the reports, and therefore that the matter did not fall under FOI rules.
A quick look at the website of the working group shows that 65% of input for the two public consultations on the EU/US trade agreement came from companies and industry associations. CEO rightly ask But who were the 114 respondents? What are they lobbying for?
The answer is: we dont know, and those who do are refusing to tell us.
What we do know, is the scope of the agreement.
The Final Report of the anonymous High Level Working Group, and a Briefing Paper from the UK government tell us that the final agreement will seek to achieve the same ends as TPP. Key areas for concern are:
Remove/reduce trade tariffs remove tariffs on imports which favour consumers choosing domestically produced goods and services.
Intellectual Property European governments rejected the US led Anti-Counterfeiting Trade Agreement (ACTA) in response to mass opposition to this potential tool of internet censorship. Despite protestations to the contrary, the TTIP could bring in ACTA through the back door, in secret, without the requirement for a democratic mandate.
Investor-State Disputes the creation of yet further grounds for which corporations can sue national governments directly, at supra-national courts. This means that rules laid down in this agreement cannot simply be overturned domestically by a subsequent government, as they face the threat of costly litigation. Given that US firm Walmart has a larger GDP than 157 countries in the world, including Norway, South Africa and Luxembourg many states would be financially outgunned by corporations seeking to over rule them.
Food Standards the EU has stricter rules than the US on food production, particularly around Genetically Modified (GM) foods and meat (chlorine washed chicken, growth hormone use etc.)
The US President has explicitly stated plans to use TTIP to overturn these (as he sees them) unscientific rules.
Corporate Power vs State Power
Proponents of Capitalism who so vociferously oppose the threat of state power (even in a democratic state), appear to have no such issues with the rise of Corporate Power, which has no democratic foundation or restraint whatsoever. This is either gross naivety, or complicity in what is, ostensibly, a corporate coup.
A significant number of corporations now have greater financial power than the majority of states, and they have used this to infiltrate and leverage the structural power of states to implement laws and subsidies on their behalf. In this final stages of this coup, the corporations will be able to cut out the middle man. Here are just two examples among many, of recent outcomes.
Removal of Tariffs
In a perfect world, protectionism through taxing imports would be unnecessary and rightly condemned. But we dont live in a free market economy, we have a small number of overwhelmingly powerful corporations and national economies using the theory of trade liberalization to decimate internal markets of smaller nations, for their own ends.
One such example would be rice and Haiti.
Thirty years ago, Haiti could feed itself. A rapidly growing and developing population meant that by the late eighties, it begin to look elsewhere to meet its full requirements. In the early 90s, the IMF and the US government pressurised Haiti to reduce its tariffs on imports, and tiny Haiti capitulated. The US government then subsidised US farmers $13bn from 1995 on, in order that they undercut domestic producers overseas. Haitis domestic rice market (and with it, much of its agriculturally based economy) was decimated.
US food producers won twice. Firstly, Haiti became the second most important US rice importer on the planet. Secondly, the resulting poverty and starvation caused by the collapse of Haitis rice market, was a boon for US Food Aid. Each year, the US taxpayer gives $1.5bn to US food corporations to produce food for Food Aid, much of which would not be required without these market wrecking policies.
Last year, tobacco firm Philip Morris used Investor to State Dispute rights created by the North American Free Trade Agreement to launch legal action against Uruguay at the World Trade Organisation. Uruguay had implemented rules that 80% of cigarette packaging must be devoted to health warnings. Philip Morris seek to claim substantial damages from the state for what it deems a trademark infringement the remaining space not adequate for their logo and branding.
Corporations are also using Investor-State Disputes to overturn government subsidies and policy that favours renewable energy, and reverse planning decisions adverse to corporate interests.
Corporations will actively exploit the increased rights in TPP and TTIP to extend the interests of the corporation which is to maximise profits. Questions of the public interest will not factor.
The Corporate Take Over
The UK Parliaments Briefing Paper on TTIP proudly announces that the plans will be worth an estimated 119bn euros a year.
Tax Evasion costs Europe one trillion euros each year this is more than the combined spending on health, and four times total spending on education.
Yet, while pan-EU agreements on ending tax evasion languish unresolved TTIP, which will benefit domestic economies to just one tenth of the value, and hand swathes of national sovereignty over to corporations and faceless supranational bodies will be completed in just 18-24 months.
According to the UK Parliaments Briefing Paper, the Trans Atlantic Trade and Investment Partnership (TTIP) between the EU and the US enters the third round of negotiations on 16th December this year, with an aim to conclude well before the pressure of the 2016 US presidential election bear down. All democratic barriers are being moved aside in order to support this goal.
In the US, there are plans to invoke the Presidents Trade Promotion Authority to make it impossible for Congress to amend or debate TPP.
While in the UK, the High Level Working Group may well be ceded powers from Downing Street enabling sections of the agreement to come into force before UK parliament has ratified it.
A significant number of the worlds democracies are being railroaded into these undemocratic agreements, by corporatized governments. These agreements will supress internet freedom, restrict civil liberties, decimate internal economies, stop developing countries distributing the lowest cost drugs, imperil public healthcare, and hand corporations the right to overturn decisions made by democratic governments in the public interest.
Your democratic representative will not be able to see or amend these agreements before they become legally binding while corporate lobbyists will not only be able to see them, but will have written them. That such an egregiously undemocratic circumstance exists, speaks volumes for the corporate control of our national governments. Why on earth would we stand by and allow the scales to tip yet further in their favour?
Dont get angry, get involved!
Join the Avaaz campaign to Stop TTIP here.
Follow the OccupyTTIP campaign on twitter. "
The more I read, the more I feel that this recent kind of half-hearted willingness towards transparency in clinical trials by Big Pharma is just a distraction from the dangerous powers they are working towards in the background.
Editing TTP to TPP in message title (DOH!)
|This message has been edited by SSRIAdmin on Feb 17, 2014 4:17 PM|
|Just as Big Pharma REALLY intend it|
TPPs 'wide-ranging effects on medicines...who may produce drugs or transmit information'
|February 17 2014, 2:35 PM |
"...In fact, if it were not for WikiLeaks, we would still be unaware of the contents of the TPP. In mid-November, WikiLeaks published a draft chapter of the agreement and the reasons for secrecy became clear. This agreement tips the scales in the balance of power between Corporations and the State tipping them firmly in favour of corporations.
The section of the agreement published by Wikileaks focuses on intellectual property, a chapter it chose due to its wide-ranging effects on medicines, publishers, internet services, civil liberties and biological patents. The subsections of the chapter make agreements relating to patents (who may produce goods or drugs), copyright (who may transmit information), trademarks (who may describe information or goods as authentic) and industrial design. And as WikiLeaks state in their press release:..."
|As in: Paroxetine 329, Zyprexa docs, et al?|
Pharmaceutical products: "each Party shall protect such data against disclosure"
|February 17 2014, 3:09 PM |
"...1. Where a Party requires, as a condition of marketing, regulatory or sanitary approval for pharmaceutical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, that Party shall protect such data against unfair commercial use. In addition, each Party shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.
Each Party may provide that the protection of data under paragraph 1, inter alia:
is limited to undisclosed test or other data, the origination of which involves a considerable effort;
is limited to pharmaceutical products that do not contain a new chemical entity that has been previously approved for marketing in the Party;
is limited to pharmaceutical products which utilize a new chemical entity;
is available only once per pharmaceutical product;
is not available for new uses or indications, new dosage forms or methods of making a pharmaceutical product;
is limited to a period of time as determined by the Party; or
may be waived to facilitate the marketing, regulatory or sanitary approval of a pharmaceutical product that is the subject of a voluntary or compulsory license, or a licence otherwise issued pursuant to the TRIPS Agreement..."