The new improved Advocates of Transparency? 'The House of GSK'

Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 5:39 pm #1

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Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 5:50 pm #2

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Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 6:36 pm #3

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Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 6:50 pm #4

<table style="width:623px;height:96px;" border="0" width="623"><tr><td valign="top" colspan="2"> </td><td valign="top" align="right"> </td></tr><tr><td colspan="2"></td></tr><tr><td valign="bottom" colspan="3"></td></tr><tr><td colspan="3">

</td></tr></table>As mentioned in the message directly above
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Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 7:01 pm #5


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 <strong>now and onward </strong>can get help where possible for adverse drug effects.

Absolutely Nothing.

Until they at least do that, how can we ever trust them again?
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Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 7:24 pm #6


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.

AS per:

http://www.theguardian.com/news/2002/jul/30/medicineandhealth
First, you market the disease... then you push the pills to treat it<div class="trackable-component"><div>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 "
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Does GSK know how many people have suffered harm since the campaign, and how many children and adults have died because of the campaign?

 

<strong>Time for the truth and for some GENUINE transparency, GSK.  </strong>
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Joined: April 19th, 2005, 7:01 pm

January 23rd, 2014, 7:37 pm #7

The light of the collectively named 'Big Pharma'.

 

 

 

 

The colour of the light is <strong>RED</strong>.
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Joined: April 19th, 2005, 7:01 pm

January 29th, 2014, 10:38 pm #8


(of which there are many) and to apologise for those deaths.
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Joined: April 19th, 2005, 7:01 pm

February 17th, 2014, 12:19 pm #9

http://www.drugs.com/news/glaxo-transparency-commitment-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 "

 

 
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Joined: April 19th, 2005, 7:01 pm

February 17th, 2014, 1:07 pm #10


Big Pharma involved at the same time as they're supposedly aiming towards clinical transparency.

 

http://www.globalresearch.ca/food-wars- ... cy/5368922
"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, <strong>major food corporations and biotech firms, joined by Big Pharma, </strong>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, <strong>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</strong>. In an unprecedented demonstration of North American<strong> and international </strong>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.
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