Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, April 10, 2007

GlaxoSmithKline Money Trail Down Under Part 3

Click on the sponsorship link on the Australian Herpes Management Forum's website and everything seems to be upfront: "The AHMF is sponsored by GlaxoSmithKline Australia and Novartis Pharmaceuticals via open educational grants.

"GlaxoSmithKline is the founding sponsor of the Australian Herpes Management Forum and the major sponsor for 2003."

But there is something that visitors to the AHMF's website are not told: the group relies entirely on Australia's main herpes drug manufacturers for its existence, and has since it was set up in 1996.

Recently appointed AHMF executive director Trish Berger estimates that in the past financial year, GlaxoSmithKline has given the AHMF about $120,000, or some 80 per cent of its budget. The other 20 per cent comes from Novartis.

There is a strong bond between the AHMF and GlaxoSmithKline, for many years the only major manufacturer of herpes treatments in Australia.

Its constitution was written by Glaxo Wellcome's (now GlaxoSmithKline) Melbourne-based law firm, Deacons, and up until August this year the forum's administration was run by public relations firm Edelman, hired on the recommendation of a well known client - GlaxoSmithKline.

Not surprisingly, Edelman's media releases about herpes on behalf of the AHMF often bore a striking resemblance to those written by the same consultants for GlaxoSmithKline.

Most of the herpes experts who have sat on the AHMF board have also worked with or advised GlaxoSmithKline and Novartis in recent years.

This year the AHMF board has begun to nudge its sponsors away to arm's length, moving to end Edelman's control of the organisation's secretariat. The organisation also created its first paid staff position, Ms Berger's. Her job includes seeking government and other non-pharmaceutical funding.

Ms Berger is keen to see the AHMF distance itself further from its sponsors, to avoid them "competing through us to get their time and profile enhanced".

AHMF chairman Professor Adrian Mindel concedes that the forum has been vulnerable to pressure from GlaxoSmithKline and Novartis because without their funding, "the Australian Herpes Management Forum would cease to exist tomorrow".

But Professor Mindel, who is also professor of sexual health medicine at Sydney University, director of Westmead Hospital's sexually transmitted infection research centre and on the editorial board of the international journal Herpes, insists that the forum and its board have remained independent of their benefactors.

"We're all professionals who are mostly academics in this area, and protecting our own reputations and independence is also terribly important... We think it is a quid pro quo (arrangement) and that we gain some benefit from that by promoting the science and improving the general health of the community. And they get the benefit in terms of their drug. And I'm not sure it's possible to completely separate the two."

In contrast, Professor Mindel says the global version of the AHMF, the International Herpes Management Forum, may be a different story.

He says although the IHMF "produces some very high quality material... whether it is completely unbiased I think is sometimes questionable" because of its close ties to drug companies.

The AHMF is one of 21 national organisations modelled on the IHMF, which was set up in 1993 to be "an authoritative voice on issues relating to the management of herpes infections". It was a worthy aim, with a wealthy backer.

GlaxoSmithKline has provided a steady income for the IHMF, funding its Herpes journal, sponsoring research awards and paying for the creation of herpes management guidelines intended for international adoption.

Today Glaxo is one of three pharmaceutical companies, along with 3M Pharmaceuticals and Novartis, keeping the IHMF afloat.

More than half of the current IHMF board have links to GlaxoSmithKline, such as leading trials of its herpes drugs, or in one case featuring in a Glaxo-sponsored television special.

In December 1999, the IHMF spawned a patient offshoot, the International Herpes Alliance, which also relied on GlaxoSmithKline funding to get started.

Novartis has since signed on as a sponsor too, and the companies' influence pervades the IHA website. Its "educational" material for journalists has been written by the "organisations (that) have made educational contributions to the International Herpes Alliance for the promotion of herpes awareness" - in other words, GlaxoSmithKline and Novartis.

Source: http://www.theage.com.au/articles/2003/12/12/1071125658355.html

GlaxoSmithKline Money Trail Down Under Part 2

When international pharmaceutical giant GlaxoSmithKline wanted to push more deeply into the Australian market with its hepatitis B vaccine, it did not hesitate.

It used a technique that had already proven so successful in France that it convinced that country's population at large there was a huge threat of contracting hepatitis B and saw a huge jump in profits.

So in 1995 it used its public relations company Hill and Knowlton to set up the Viral Hepatitis Prevention Board to tell Australians how at risk they were and help lobby for government approval for universal immunisation of children for hepatitis B.

About 10 medical experts, including Dr Tilman Ruff, who would later go to work for GlaxoSmithKline as medical director of its vaccine division, were recruited to make up the board.

Their airfares and other expenses were paid to attend board meetings around the country organised by Hill and Knowlton, while material warning of the risks of hepatitis B prepared by the public relations company was released under the board's name.

"The idea basically came from GlaxoSmithKline (then SmithKline Beecham) who used Hill and Knowlton as their PR company and they basically did quite a lot of the organising, they provided the secretariat and so on for the meetings," admits board chairwoman Dr Sandy Thompson.

"It always is a little bit of a difficult relationship, I suppose, because clearly they are in the business of wanting to sell vaccines."

The campaign was a success. The Federal Government announced $14 million funding for hepatitis B immunisation of pre-adolescents in 1997 and all infants by 2000.

But GlaxoSmithKline also had a vaccine against hepatitis A and so the board began targeting the risks of that version of the virus, just as its European counterpart had done a few years earlier.

In July last year the board issued a 14-page booklet sponsored by GlaxoSmithKline and prepared by Hill and Knowlton, warning child care workers they were at risk of catching hepatitis A if they were not immunised.

The booklet made no mention that GlaxoSmithKline made the hepatitis A vaccine, which costs $120 for a two-dose course of injections.

The booklet also warned of the dangers from measles, rubella and chickenpox, for which GlaxoSmithKline also markets vaccines.

In April this year a member of the hepatitis prevention board, Professor Graham Cooksley from Royal Brisbane Hospital, chaired a satellite symposium in Sydney funded with a grant from GlaxoSmithKline on the topic: "Should we move towards universal vaccination for hepatitis A?"

Dr Thompson says the Viral Hepatitis Prevention Board has now "basically gone into recess" because members felt "we had run our course a little bit".

She said board members had been keen to try to do something in the area of hepatitis C, but this had created a "difficult issue" with GlaxoSmithKline, because the company did not have a vaccine it could sell.

"That wasn't something that GSK had any vested interest in," she said.

But Dr Thompson rejects any suggestion that there was any conflict of interest surrounding her role with the board.

"I work in public health, so there was no conflict for me in trying to prevent viral hepatitis," she said. "I didn't see that as conflict of interest. Immunisation is one of the success stories of public health. We need to promote immunisation, we need to use vaccines effectively. So I didn't feel any conflict of interest.

"I know often these boards and expert panels people get paid, but basically with VHPB we didn't get paid.

"I think we were just pleased to have the opportunity to do a bit of lobbying in an area that most of us believed in."

GlaxoSmithKline has also targeted another potential growth market for its hepatitis vaccines through a second organisation it funded, the Travel Health Advisory Group.

In September the group released, through Hill and Knowlton, details of a survey funded by GlaxoSmithKline showing that more than half of the Australians travelling overseas did not seek medical advice about the risks of such diseases as hepatitis A and B.

The press release quoted the chairman of the group, Dr Bernie Hudson from Sydney's Royal North Shore Hospital, warning of the dangers of the two types of hepatitis.

It did not mention that the survey, originally published in the Medical Journal of Australia, had been funded by GlaxoSmithKline.

Dr Hudson did not return calls from The Age.

One of the members of the travel group is Viral Hepatitis Prevention Board member Dr Tilman, the medical head of GlaxoSmithKline's vaccine division.

Source: http://www.theage.com.au/articles/2003/12/12/1071125658355.html

GlaxoSmithKline Money Trail Down Under Part One

Gary Hughes and Liz Minchin follow the big pharmaceutical money trail to reveal who is really behind the health advice we are getting.

Many of us with chronic health problems rely on advocacy groups and peak medical bodies for independent advice and support. But just how independent is that advice and are we being given the full picture?

The Age has found that many advocacy groups are becoming hooked on sponsorship dollars from drug companies and these international corporations are in turn using them to promote their products in Australia's booming $5 billion drug market.

Gary Hughes and Liz Minchin follow the big pharmaceutical money trail to reveal who is really behind the health advice we are getting.



Meet Puff the purple dragon. Last year Puff became the public face of a new National Asthma Council awareness campaign to encourage asthmatics to better manage their medications.

But Puff had an earlier existence. He began life as the registered trademark used by international pharmaceutical giant GlaxoSmithKline to market one of its asthma drugs, Seretide, to doctors. His colour matches the packaging for Seretide.

It was GlaxoSmithKline's idea for the NAC to use its symbol and give Puff a new, much more public role encouraging asthmatics to update their medication regimens.

GlaxoSmithKline, which is the world's biggest seller of asthma medications, also provided financial support for the television campaign and to develop an interactive internet quiz for the NAC website to check whether someone's asthma was under control. Even if you answer "no" to the initial question "do you have asthma?" and say you have no symptoms, Puff advises you that your asthma appears to be under control, but you should visit your doctor anyway for a medical review.

NAC chief executive Kristine Whorlow defends the use of a pharmaceutical company logo to spearhead a supposedly independent campaign, saying market research before the campaign showed there was no public recognition of Puff. The board of the council, which is the peak asthma body in Australia, also discussed potential conflicts of interest.

"When GSK was talking to us and we were talking to them about doing another consumer campaign and they came up with the idea of using Puff, we discussed that very thoroughly here at our board meetings and we decided to go ahead with it," she said.

"But we only went ahead with it when we looked at the consumer research showing that the consumers were not aware of the dragon at all."

Ms Whorlow said the Puff campaign, every word of which was vetted by the NAC, had been especially successful in targeting children.

It is not surprising that the NAC and GlaxoSmithKline should work so closely together on such a campaign.

GlaxoSmithKline was the founding sponsor of the council when it was launched more than a decade ago and remains its principal source of funds. According to the NAC's website, other sponsors in 2002 included the pharmaceutical companies AstraZeneca, Aventis, Boehringer Ingleheim, Schering-Plough, Merck, Novartis and Proctor and Gamble.

According to Ms Whorlow, up to 60 per cent of the council's annual budget of between $800,000 and $1 million comes from the pockets of international pharmaceutical companies.

When the council launched a new edition of its Asthma Management Handbook in March last year, GlaxoSmithKline was there again as sponsor of the publication. A Newspoll survey released at the launch showing 50 per cent of asthmatics were not taking their medications as prescribed had been provided by GlaxoSmithKline's public relations company, Hill and Knowlton.

The strategy of targeting patient groups to increase its market has been a successful one for GlaxoSmithKline. In December last year a briefing paper prepared by Hill and Knowlton internationally boasted how GlaxoSmithKline had become the "number one partner" in patient groups and associations, established strong relationships with physicians and "did the same lobbying in the clinical development of the product" to become the market leader in selling respiratory products.

Ms Whorlow accepts that pharmaceutical companies view sponsorship as a marketing exercise.

"The reality of having a sponsorship, whether it's with a pharmaceutical company or a broom company, is that they want an advantage out of it as well," she says. "It may be general good corporate citizenship, but more often nowadays, to be absolutely realistic about sponsorship, it is because of increased market share.

"The old days of philanthropy have by and large gone. You get some companies which wish to have a focus on good corporate citizenship, although there is less of that around now.

"Companies want to sponsor causes allied to their marketing potential."

Ms Whorlow said the NAC and its sponsors shared a common goal "because we want more people on long-term preventative medication so they don't experience serious asthma symptoms".

The independence of the council was protected by a set of strict guidelines, including the retention of editorial control over publications and the ability of NAC spokespeople to speak freely. But the guidelines also provide for details of individual sponsorship contracts, including the amounts involved, to be kept secret.

"We would never be associated with anything that put forward a wrong or incorrect message," Ms Whorlow said. "Our credibility, our reputation, is the most important thing to us."

The NAC also uses World Asthma Day, held in May each year, as a key part of its strategy to raise community awareness. Since 1998, World Asthma Day has been run by an organisation called the Global Initiative for Asthma, or GINA.

GINA, according to its website, is sponsored entirely by international pharmaceutical companies, including GlaxoSmithKline. It is operated by an American company called Medical Communication Resources, (no link to url can be found) which describes itself as helping the pharmaceutical industry "find solutions to significant marketing and education challenges" through promoting, repositioning or launching products.

Medical Communications Resources also does the behind-the-scenes co-ordination of World Asthma Day and the company's chief, Dr Larry Grouse, is listed as a member of GINA's executive committee.

GINA's sponsors provide money to leading international asthma experts to gather several times a year, normally at four or five-star hotels in Europe, to discuss the latest research as part of their role in drawing up international treatment guidelines for asthma.

Most of those same sponsors are also the financial backers of another international group, the Global Initiative for Chronic Obstructive Lung Disease or GOLD, that is almost a mirror of GINA and also operated by Medical Communications Resources.

Like GINA, GOLD also runs a World Chronic Obstructive Pulmonary Disease Day each year and has Dr Grouse listed as an executive committee member. Websites for the two groups, that are maintained by Medical Communications Resources, are virtually identical.

Indeed GINA and GOLD operate so closely that at a meeting of GOLD sponsors in London in February it was suggested that future meetings for drug company supporters of the two groups be combined for convenience.

Global treatment guidelines developed by GINA and GOLD medical advisers for asthma and chronic obstructive pulmonary disease have been used as models for treatment guidelines issued by Australian medical organisations that have links to the two groups.

To help promote the adoption of its international asthma treatment guidelines, GINA set up another group called the International Asthma Quality of Care Initiative. The group is also run by Medical Communications Resources and is funded by GINA's pharmaceutical company sponsors.

The latest asthma treatment guidelines will be launched in Melbourne in February at the annual conference of the International Primary Care Respiratory Group, a global umbrella group for respiratory care organisations.

The IPCRG is sponsored by six international drug companies, including GlaxoSmithKline, Boehringer Ingelheim, Novartis and Merck. The IPCRG's Melbourne conference, which is being hosted by the National Asthma Council, is also being sponsored by pharmaceutical companies.

Ms Whorlow said she was unaware of Medical Communications Resources' role in helping drug companies market their products, but defended the integrity of treatment guidelines developed by GINA and GOLD.

The guidelines had been developed by "the world's experts in asthma" and they would never compromise themselves with pharmaceutical companies, she said.

The reality was that not-for-profit organisations such as the NAC found it hard to raise money, particularly as it did not have tax deductibility status to help it attract public donations.

"There are no other options. We've got to have corporate sector support," she said.

Source: http://www.theage.com.au/articles/2003/12/12/1071125658355.html

Another Seroxat Comic


From the mind of Sir Oxat

Monday, April 09, 2007

Russia charges 3 doctors over Glaxo vaccine tests

Source: Reuters

MOSCOW, April 2 (Reuters) - Russian prosecutors said on Monday they had charged three doctors with breaching medical procedures in a trial of GlaxoSmithKline vaccines that investigators said made several young children ill.

The prosecutors said that starting in 2005 a hospital in Volgograd, 1,100 km (675 miles) southeast of Moscow, tested the vaccines on 112 children between one and two years of age without informing their parents first.

The vaccines are against childhood diseases including chickenpox.

Glaxo, Europe's biggest drug maker, said it would not comment at this stage of the investigation. Glaxo had earlier denied any wrongdoing.

"We will comment on the case only once we have received more information and details of the current criminal investigation," a Glaxo spokesman in Moscow said.

According to the prosecutors, Glaxo paid the Volgograd clinic's chief researcher 1.5 million roubles ($57,710) and her deputy around 700,000 roubles ($26,930) to conduct the trials, which made some children ill.

"The criminal case was launched after a local resident lodged a complaint at the (Volgograd) prosecutor's office saying her daughter suffered from complications after a visit to the clinic," the prosecutors said in a statement.

"A forensic study established that the deterioration of the child's health was caused by the vaccine she had received ... The children were sent to the clinic as if they had to undergo some kind of routine, planned inoculation."

The prosecutors said on Monday that the clinic had broken the law by testing the vaccines -- Varilrix and Priorix-Tetra -- on children with weak immunity and those suffering from neurological diseases and other illnesses.

According to the contract, only healthy children had been due to take part in the experiment, the prosecutors had said.

The Glaxo spokesman said neither vaccine is so far licensed for use in Russia.

"Russia still lacks an efficient vaccine against childhood diseases like chickenpox and the trial aimed to test the two vaccines and finally register them in the country," he said.

He said Varilrix has been in widespread use outside Russia since the 1990s. Priorix-Tetra is licensed for use in Australia and Germany and is awaiting licences in more than 20 European Union states, said the Glaxo spokesman.

Glaxo using children again purely to line their own pockets

Sunday, April 08, 2007

Paxil Destroys Your Life

**NEW BLOG**

Paxil Destroys Your Life

http://paxildestroys.wordpress.com/

More on Primhe

When I first started researching into the whole Seroxat/GSK/MHRA scandal over 4 years ago I never anticipated the dirt and insidious characters I would come across... least of all from patient support groups for Mental Health. What is going on over at Primhe?

In 2007 they proudly boast on their webpage:

"The aims and objectives of Primhe came out of four intensive meetings with members of the Executive Committee and Founding Partners during 1999 - and well before the launch of the National Service Framework for Mental Health (published by the UK Government). Because all present contributed to their development, they are endorsed and 'owned' by all and demonstrate the partnership and collaborative spirit which are the essence of Primhe."

However, thanks to the wonderful internet archive webpage 'Wayback.com' we can now see the Primhe webpage from the year 2000.

Once again Primhe boasts:

Launched in March 1999, PriMHE exists principally to help the Primary Health Care Professional (PHCP) achieve and deliver the best standards of mental health care. As a unique multi-partner collaboration and a non-profit making organisation, PriMHE can and will support PHCPs over time, both locally and nationally.

...etc, etc

Look closely though at Primhe's funders - They don't allow you to do this on the page from today, though they do state that Lundbeck Beck are Primhe's founding funders... but sit tightly in your DeLorean, grip the steering wheel and you will see the organisations that fund Primhe:

Primehe funders:
PARTNERS
Lundbeck
Pfizer
Pharmacia
Priory Healthcare
Smithkline Beecham

Amazing isn't it?

I've been researching with the author of Seroxat Secrets all morning. He has known about this for some time and is now digging more dirt as I type this.

So basically, we have a patient care group for mental health who are funded by major Pharmaceutical Companies who, coincidently, happen to manufacture drugs for patients with mental health problems.

The power of Pharma ladies & gentlemen

Bob

Paxil 2885 reports

Source: http://patientsville.com

PAXIL
Total reports: 2885
Reported deaths: 181
Reported hospitalizations: 482

FDA safety alerts: 2004 2005 2006

Paroxetine or paroxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It was released in 1992 by the pharmaceutical company GlaxoSmithKline and has since become one of the most prescribed antidepressants on the market due to its efficacy in treating depression as well as a spectrum of anxiety disorders ranging from panic attacks to phobias.

Approval History

Now read all about the 2885 PAXIL serious adverse events reported to Food and Drug Administration (FDA). HERE

Saturday, April 07, 2007

More on the ties with Patient Care Groups

Following on from Seroxat Secrets two stories, What a tangled web we weave… and What a tangled web we weave…2

Primhe is the UK primary care professional charity dedicated to mental health and the care of those with mental illness in primary care settings. Their mantra is "bringing 'mental' into the mainstream".

Let's just take a little look at Primhe shall we.

Pharmaceutical Company, Lundbeck Ltd are Primhe's Founding Funders

Of the three antidepressants Lundbeck Ltd produce there have been the following reports:

CIPRALEX
Total reports: 75
Reported deaths: 9
Reported hospitalizations: 30
Learn about CIPRALEX serious adverse events reported to Food and Drug Administration (FDA).

LEXAPRO
Total reports: 413
Reported deaths: 71
Reported hospitalizations: 136
Learn about LEXAPRO serious adverse events reported to Food and Drug Administration (FDA).

SEROPLEX
Total reports: 74
Reported deaths: 15
Reported hospitalizations: 39
Learn about SEROPLEX serious adverse events reported to Food and Drug Administration (FDA).

These drugs are all used to treat depression (Mental Health) so the question I have to ask is... Why are Primhe associated with a company that manufacture drugs that are obviously dangerous to the very same people Primhe are supposed to be looking out for?

Here is the Chief Executive of Primhe, Dr Chris Manning, discussing this very issue.
(Opens up Real Player)

You happy about this? I most definately am not!

Bob

Friday, April 06, 2007

Depression Alliance - Seroxat Secrets Investigation

Some shenanigans have been unearthed by Seroxat Secrets that may surprise some of you.

It seems Depression Alliance have took more than 80% of their funding from Pharma's in the past. Not only that but the silence regarding Seroxat has been deafening. They have not spoke out against it whatsover, in fact the sole voice coming from Depression Alliance regarding Seroxat was an attack on the accuracy of programmes on the subject made by the BBC’s Panorama.

Seroxat Secrets has been investigating in depth the underhand goings on.

Read HERE then once you have recovered from the shock that an alliance set up to help depressed people are recieving funding from the drug barons at the pharma's, read another gem from Seroxat Secrets HERE

It seems the popular myspace is now a place to 'big up' Seroxat.

All will be revealed over at Seroxat Secrets

COMMITTEE ON SAFETY OF MEDICINES Individuals Part One

COMMITTEE ON SAFETY OF MEDICINES MEMBER

Professor A Blenkinsopp - GSK Specific – Fees

The weblog of Professor Alison Blenkinsopp and Dr John Blenkinsopp.

"Healthcare starts with self-care."

Hmmm - nice statement... Your GSK fees should certainly be taking good care of yourself!

What is a conflict of interest?

Make sure you click the links folks


What is a Conflict of Interest?

A situation in which an investigator’s primary interests compete with secondary interests;
Those secondary interests may or may appear to influence the investigator’s judgment;
This situation may lead to adverse outcomes.

From Mildred Cho, Stanford University

----

What is conflict of interest?

1 INTEREST/DUTY
Research integrity
Patient welfare
Education

2 INTEREST
Financial gain
Recognition

JUDGEMENT
UNDUE INFLUENCE
ADVERSE OUTCOME

Stanford University

----

What Do We Know?
Competing interests increasingly challenge these underlying principles

Financial interests
Career interests
Personal interests

Is there evidence to suggest that conflicts of interest are a problem for clinical research?

Answer: Evidence suggests that industry sponsorship and financial ties contribute to biased outcomes.

What’s the evidence?

Suppression of results
Secrecy among researchers
Bypassing the peer review system
Influence over study design and interpretation of data

The Evidence: Studies of financial ties of investigators

Bias toward favorable results

----

Conflict of Interest?

"I have never been bought, I cannot be bought. I am an icon, and I have a reputation for honesty and integrity, and let the chips fall where they may. It is true that there are people in my profession who could not receive a million-dollar grant and stay objective. But I do.”

Courtesy “No Free Lunch” website

Please contact me if you would like a guest post considered for publication on my blog.