Assumption of involvement re: financial backing

[Guest guest]

Hi , I'm sending tons of info for you, so that you may see for

yourself. Big pharma is the only entity that is getting away with unbiased

information. Any where else in government, and the scientific community there

are watch

dogs. Checks and balances, but the pharma companies are their own checks and

balances, and they do it blatantly. They are the biggest contributors in

Washington, they have more lobbyist than anyone else. They infiltrate at the

highest levels. If anyone thinks that research isn't compromised, they are

either

naive, earn a living off pharma, or have someone near and dear to them earning a

living off pharma. Sorry to be so cynical, but have been at this for a long

time.

You will also see from the following links that when a vaccine is approved,

it is not the end. They are still being trialed with our children being the

guinnea pigs. Look at DAPTACEL's approval letter below. Also, the children in

Canada are guinnea pigs a long time before the US starts using the vaccine. Case

in point the new adolescent pertussis vaccine, which is being used in Canada

right now. Estimated approval for US, 2005. ADACEL

http://www.aventispasteur.ca/avp_content/docs/ca_products/ADACEL_E.pdf

Critical Decisions Count

http://users.adelphia.net/~cdc/index.html

Articles to read from this link.

http://users.adelphia.net/~cdc/PharmaceuticalCompanys.htm#Gen

Research sponsored by drug companies is biased. This week in the BMJ Volume

326, Number 7400, Issue of 31 May 2003.

Pharmaceutical industry sponsorship and research outcome and quality:

systematic review

Evidence b(i)ased medicine—selective reporting from studies sponsored by

pharmaceutical industry: review of studies in new drug applications

Characteristics of general practitioners who frequently see drug industry

representatives: national cross sectional study.

1: Entanglement - Who pays for the pizza? Redefining the relationships

between doctors and drug companies-In this two part article, a journalist based

in

Washington DC explores the brewing conflicts at one of the world's leading

medical campuses as it joins the wider global debate about how to redefine

relations with big pharmaceutical companies

2: Disentanglement - Who pays for the pizza? Redefining the relationships

between doctors and drug companies

How to dance with porcupines: rules and guidelines on doctors' relations with

drug companies - Interactions between doctors and drug companies can lead to

ethical dilemmas. This article gives an overview of the guidance and codes of

practice that aim to regulate the relationship

Medical journals and pharmaceutical companies: uneasy bedfellows - Many

medical journals have a substantial income from pharmaceutical companies from

the

purchasing of advertising and reprints and the sponsoring of supplements. Is

this funding corrupting journals?

Unhealthy spin - Public relations companies are experts at " third party

technique " —helping the drug industry separate the message from what could be

seen

as a self interested messenger. But most journalists have a sketchy idea about

how the public relations industry works, and thereby are vulnerable to

uncritically accepting the disguised messages of the drug industry

Relationships between the pharmaceutical industry and patients' organisations

- Pharmaceutical companies and patients' organisations are unequal partners

in a collaboration that has developed over the years—and this raises serious

questions

BMJ Reviews-Website Of The Week:Doctors and the drug industry

More on pharma involvement. You will see these articles coming out of the UK,

and Australia, but very rarely see anything derogatory coming from the US.

http://www.mja.com.au/public/issues/180_08_190404/bre10055_fm.html

http://www.mja.com.au/public/issues/180_08_190404/hut10183_fm.html

http://www.mja.com.au/public/issues/180_08_190404/rog10715_fm.html

DAPTACEL approval letter.

http://www.fda.gov/cber/approvltr/dtapave051402L.htm

You have agreed to submit a clinical development plan to CBER by March 2003

for a study(ies) to assess the use of DAPTACEL as a fifth dose at 4-6 years of

age following four previous doses of DAPTACEL. You have agreed to initiate the

study(ies) no later than May 2006.

You have agreed to complete the ongoing clinical study, ----------, by

December 2003 (defined as the Last Person Out following 180-day safety

follow-up)

and to perform the serology and safety analysis by August 2004 in order to

submit a final clinical report to your existing ---------- by December 2004. You

have also agreed to submit a Prior Approval Supplement to revise the DAPTACEL

package insert to include the data from ---------- by March 2005.

You have agreed to perform a Phase 4 study in children in the United States

in order to assess the impact of Prevnar administration on DAPTACEL antigens

under protocol ----------. You have agreed to submit further protocol revisions,

if necessary, within 1 month following each CBER review and to initiate the

study within 3 months of CBER protocol approval or by August 1, 2002, whichever

is later.

You have agreed to initiate a Phase 4 post-marketing study, protocol

----------, designed to assess the risks of hypotonic-hyporesponsive episodes,

seizures and other possible rare events following DAPTACEL and other

concomitantly

administered vaccines following immunization at 2, 4, 6, and 15-18 months of

age. You also commit to submit further protocol revisions within 6 weeks

following each CBER review and to initiate the study within 3 months of CBER

protocol

approval, or by October 1, 2002, whichever is later. You have agreed that you

will notify us of any plans to prematurely terminate the study (e.g., study

site’s decision to use an alternative product). In the event that insufficient

data are available from this study (protocol ----------) to assess the risk of

seizures, you have agreed to submit a protocol(s) for an additional study(ies)

within 6 months from the date of notifying CBER of the intent to terminate

the study in order to fulfill this post-marketing commitment.

[Guest guest]

One thing I think we should be careful of as a group, is the immediate

assumption that monetary funding from Big Pharma means that the integrity of

any potential research is compromised.

If we constantly insist that any time Big Pharma contributes $ they are

biasing the research, we begin to sound like Chicken Little and

anti-vaccination groups are already assumed (by the mainstream) to be

flighty, airheaded, alarmists at the best of times.

Is there any way that any list member (and yes that could be myself) could

verify the percentage of funding provided, the actual affiliations of the

researchers, etc.

I know many times it is verified that Big Pharma is not only contributing

the $, but influencing the outcome and researchers who should remain

unbiased are in fact puppets of the companies, but it behooves us to remain

accurate in our assessments.

TTFN

Sider

Mom to , friend to Indy, the buckskin pitbull and Taco, the Gunsmoke

gelding

Remember, one day you're a hero. . . the next a zero!

jsider@...

[Guest guest]

Anyone is free to repost this. Please remove all personal info, and

spell guinnea with one 'n'. Didn't spell check.

They are still being trialed with our children being the

> guinnea pigs. Look at DAPTACEL's approval letter below. Also, the

children in

> Canada are guinnea pigs a long time before the US starts using the

vaccine. Case

> in point the new adolescent pertussis vaccine, which is being used

in Canada

> right now. Estimated approval for US, 2005. ADACEL

>

http://www.aventispasteur.ca/avp_content/docs/ca_products/ADACEL_E.pdf