https://www.scriptonitedaily.com/2013/1 ... democracy/
http://www.drugs.com/news/glaxo-transpa ... 49425.html
"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,<strong> 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.</strong>
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. <strong>They maintain the drug maker has balked at their request and raised questions about its commitment to releasing data.</strong>
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. <strong>The company has come up with the perfect way to appear to be transparent while making actual access to data close to impossible, </strong>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 <strong>that Glaxo is failing to live up to its commitments.</strong> 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.
<strong>In other words, a great deal of parsing is under way</strong>. 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 "
"The Trans Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TTIP) <strong>enshrine the rights of Corporations under International Law, restricting future governments from overturning the changes through fear of costly legal action. </strong>They are the largest trade agreements in history, and <strong>yet are not open for review, debate or amendment by national parliaments or the public.</strong>
<p align="center">The Trans Pacific Partnership (TPP)
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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.
<p align="center">The Transatlantic Trade and Investment Partnership
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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.
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.
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.
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.
<p align="center">Corporate Power vs State Power
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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.
<p align="center">The Corporate Take Over
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<strong>The UK Parliaments Briefing Paper on TTIP proudly announces that the plans will be worth an estimated </strong><strong>119bn euros a year</strong>
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<strong> 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 </strong><strong>well before the pressure of the 2016 US presidential election bear down.</strong>
<strong> All democratic barriers are being moved aside in order to support this goal.</strong>
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!)