Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Monday, February 25, 2008

Glaxo - MCA - The forgotten bad press

Thought I'd remind those 'outsiders' visiting this blog of who it is I've actually got a gripe with here... it is my beleif that they lied to me and millions of others about the safety and efficacy of Seroxat in BOTH adults AND children. Here are some more of their drugs where I believe they has been less than honest

Lymerix had caused controversy in recent years, as patients said they were sickened by the vaccine and asked the government to restrict sales. Some filed lawsuits against maker GlaxoSmithKline...

A mass immunisation campaign with a Urabe-containing MMR vaccine was carried out in 1997 in the city of Salvador, NE Brazil, with a target population of children aged 1-11 years.
There was an outbreak of aseptic meningitis following the mass campaign. The MMR vaccine used in Salvador was the Pluserix vaccine supplied by SmithKline Beecham Pharmaceuticals, London, UK...

"You've seen the chemical make-up of the substance - it contains benzene, hydrochloric acid and sulphuric acid," he said. "How could they ever think that injecting those chemicals into somebody's back would not be harmful?" Doctors were warned not to spill the chemical on rubber because it destroys it and dissolves polystyrene cups...

Glaxo executives were steaming in early 1999 over the work ofbiostatistician Michael Elsahoff and other FDA reviewers who had examinedthe company's new flu drug, Relenza. The reviewers found that Relenza was no more effective than a placeboin treating common flu symptoms among American patients...

When the antibiotic Raxar was approved on Nov. 6, 1997, FDA officials knew that it too might cause irregular rhythm and stop a patient's heart. An agency medical officer, Dr. Andrea N. Meyerhoff, suspected that two of four patients who died after taking Raxar in clinical trials possibly suffered heart-rhythm disturbances caused by the drug. Meyerhoff noted in her review that the drug manufacturer, Glaxo Wellcome Inc., said Raxar played no role in the deaths. But Meyerhoff wrote that the two cases posed an open question...

Agency officials agreed in July 1999 to conduct a fast-track medicalreview of Lotronex, a pill from Glaxo Wellcome Inc. intended to treatirritable bowel syndrome in women. Senior found other troubling results. He warned that 27% of thepatients who took Lotronex in Glaxo's studies experienced constipation. Henoted that not a single patient who took a placebo pill developed ischemiccolitis and that only 5% of the placebo patients got constipated...

A CORONER has raised fresh concerns over the safety of anti-smoking drug Zyban after a man died within days of taking it. A spokeswoman for GlaxoSmithKline which produces Zyban, said it should be avoided by patients with head injuries, heart, liver or kidney conditions or those with brain tumours. She added: "Zyban is contra-indicated in patients with a prior or current seizure disorder such as epilepsy"...

GSK at centre of Russian vaccine scandal
The pharmaceutical giant GlaxoSmithKline has become embroiled in a vaccine-testing scandal in southern Russia after prosecutors set out criminal charges against three doctors involved in a trial of the company's drugs...

UK babies given toxic vaccines, admits Glaxo
British drug giant GlaxoSmithKline has finally admitted that thousands of babies in this country were inoculated with a batch of toxic whooping cough vaccines in the 1970s. Some experts believe that these Trivax vaccines - which had not passed critical company safety tests - may have caused permanent brain damage and even fatalities in young children...

Senate Report Alleges GSK Intimidation Over Avandia Concerns
Two high-ranking senators placed a report in the Congressional Record detailing how GlaxoSmithKline (GSK) employees allegedly intimidated a scientist who raised concerns over the company’s Type 2 diabetes drug Avandia...

Orphans used for HIV trials
GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as `laboratory animals'...

Have to throw the MHRA in here to.

They've always denied a conflict of interest... but were caught out some years back when they were known as the Medicines Control Agency - Or MCA

Many Government advisers on the safety of medicines have close financial ties with the pharmaceutical giants who produce the controversial measles, mumps and rubella jab. A Sunday Express investigation has found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA) committees are linked to GlaxoSmithKline, Aventis Pasteur or Merck, Sharpe and Dohme.

It was not long after that the MCA were 'revamped' and changed its name to the MHRA.

Lets see some more MCA cock-ups shall we?

Medicines Division was admitted by its then management to have been in chaos in 1988, year that MMR was licensed in UK (for details, see Draft Factual Account 17 of Evidence to BSE Inquiry, pp 31-33).

Had no effective method of finding files, and severe staff shortages in key areas

Product licence renewals were handled purely administratively without scientific input. MMR wasn’t a renewal, but may have been treated as little more than one, as singles already licensed, and long-term complications not foreseen. Therefore highly likely that MMR went through "on the nod"

Follow-up of trial children was only three weeks (chicken & egg situation, with autism being missed, MMR then being declared safe, then safety record used to repudiate autism connection - a circular argument)

DoH uses circular argument, "MMR has good safety record", therefore no problem. But slow degeneration into autism not recognised as consequence, and no figures being kept by MCA on this. Therefore autism numbers not added in, and safety record remains "good".

The Medicines Control Agency’ adverse reaction warning system, known as the Yellow Card system, by their own admission only picks up 10-15% of even serious adverse reactions (source: Guidance on Interpretation of Yellow Card Data, MCA, 1997). System woefully weak.

Yellow Card unable to identify problem because it must be shown that adverse event occurs more frequently in vaccinated than unvaccinated population - very difficult to do when almost all children vaccinated. (source: letter of MCA of 21/8/98 to David Thrower)

Yellow Card depends on doctors, dentists, coroners and hospital pharmacists to file reports (source: MCA). But these are unlikely to be able to make the link between autism and MMR.

Adverse reaction reports are added to the ADROIT database, introduced in 1991. However, the database can only deal with the data it actually receives. If a syndrome is missed completely, then there will be no data in the database.

Yellow Card is voluntary for health professionals, but compulsory for pharmaceuticals manufacturers. But this depends on adverse reactions being reported to manufacturers - again, unlikely.

Parents must also be able to make link between MMR/autism. This was not possible pre-1998, as publicity had never been given to connection between vaccination and later degeneration into autism

In any case, "it has been estimated.....that only 10-15% of serious ADRs (adverse drug reactions) are reported" (1997 Guidance Sheet issued by MCA), and " is accepted that spontaneous reporting schemes have limitations" (source: MCA letter of 29/3/99 to David Thrower). And worse still, "Autism has been very rarely reported as an adverse drug reaction.....These figures are unsurprising since autism is not a recognised ADR to any particular medicinal substance" (Source: letter of MCA of 29/3/99 to David Thrower). The chicken-and-egg argument again.

And a potentially-significant admission, "Evidence from the Yellow Card scheme is unlikely to resolve the issue as to whether or not autism could be causally associated with MMR vaccine" (Source: letter of MCA of 29/3/99 to David Thrower)

MCA’s estimate of only 10-15% of ADRs being reported may even itself be optimistic - West Midlands Centre for Adverse Drug Reactions Reporting did survey and found rate of only 6.3% of all ADRs reported.

All recent improvements to Yellow Card have been irrelevant to autism detection (extension of system to hospital pharmacists, GP prescribing systems, community pharmacists, nurses)

Similar situation in USA - "On the basis of Vaccine Adverse Event Reporting System alone, we don’t have proof that vaccines are not contributing to (vaccine-related problems)(source: Caveats to Interpretation of VAERS Data, Centre for Biologics Evaluation & Research, VAERS, 1998)

Whole monitoring system is therefore passive, and irrelevant to autism - like smoke-alarm with no battery.


Call them what you will; Glaxo Wellcome, SmithKline Beecham, GlaxoSmithKline. The MCA or The MHRA - After reading these catalogue of failures - DO YOU TRUST THEM?

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7



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