Monthly Archives: May 2011

In whom we trust…European Medicines Agency

European Parliament refuses to approve European Medicines Agency accounts

Adam Smith
Science and Communications Officer, ANH-Intl

European Parliamentarians have refused to sign off the European Medicines Agency’s accounts, citing “grave” concerns
The MEPs are worried about the Agency’s lack of independence from pharmaceutical companies
The Nordic Cochrane Centre accuses the Agency of working to protect pharmaceutical profits
This is among several signs of MEPs increasingly questioning aspects of the European Union’s stance aspects relating to natural healthcare

Members of the European Parliament (MEPs) have bared their teeth in no uncertain manner over the independence of the European Medicines Agency (EMA), the body entrusted to determine the safety and effectiveness of drugs in the European Union (EU).

In a damning indictment of the EMA, of the type many people had despaired of ever witnessing in the closed environment of the European Parliament, an overwhelming majority of MEPs – 637 to 4! – voted not to sign off on the EMA’s accounts.

MEPs said that there appears to be no proper guarantee of the independence of experts hired to carry out scientific evaluations of pharmaceutical drugs. Furthermore, MEPs believe that some of the experts involved in evaluating drugs have conflicting interests and that the EMA’s hiring practices are dubious and indicate further conflicts of interest, in particular the way in which they get funding and spend public money.

In whom we trust…vaccine researchers

The now infamous ‘Danish Study’

American prosecutors are attempting to extradite a Danish scientist.

Poul Thorsen has been charged with 13 counts of wire fraud and nine counts of money laundering; a federal grand jury alleges that Thorsen stole over $1 million from autism research funding between February 2004 and June 2008.

Thorsen is said to have used the proceeds to buy a home in Atlanta, two cars and a Harley Davidson. He is said to have stolen the money while serving as the ‘principal investigator’ for a program that studied the relationship between autism and exposure to vaccines.

The Copenhagen Post reports:

“… [O]ver the four-year period he submitted over a dozen false invoices from the CDC for research expenses to Aarhus University, where he held a faculty position, instructing them to transfer the funds to a CDC account, which was in fact his personal account …

Thorsen’s research on autism is widely known in academic circles, where he was until this week a highly respected figure. A paper of his on the subject, which is known as ‘The Danish Study’, is quoted extensively to refute the autism vaccine connection.” And not forgetting Paul Offitt…
Attkisson had previously reported on the vaccine industry ties of Dr. Offit and others in a CBS Evening News report ‘How Independent Are Vaccine Defenders?

… Offit told the OC Register that he provided CBS News “the details of his relationship … with pharmaceutical company Merck”, but documents provided by CBS News indicate Offit did not disclose all of his financial relationships with Merck.

Response to Paul Offit

Paul Offit on the Dangers of the Anti-Vaccine Movement

The anti-vaccine movement, as called, is made up of parents with children they believe
have been vaccine damaged, and health practitioners who see many possible adverse
reactions to vaccines.  

The term anti-vaccine is derogatory and denies proper discussion about a product (vaccines)
which have no benign placebo, no control group and no long term study into the outcomes for
the health of the vaccinated and un vaccinated.

Parents have the right to question prophylactic interventions and potentially damaging
products for their babies.  It is the state's responsibility to provide sound safety testing
and active surveillance systems for such products - suppressing the user's valid concerns
goes against the important phase 5 in the community.

Each country uses different programs, so vaccines are not an exact science.
Vaccines like the BCG are not mandatory in the US due to low efficacy and the Hep B vaccine
in France is non mandatory while the link between this vaccine and Multiple Sclerosis in
children is being researched.

Please pass my comments on to Paul Offitt and the interviewer
(I will update this post when I get a full reply rather than an acknowlegement)

Hepatitus B vaccine – Serious ADRs

The hepatitis B vaccine is given to U.S. infants at birth. But there is impressive evidence that for a preventive measure, hepatitis B vaccine is remarkable for the frequency, variety, and severity of complications from its use.

Hepatitis B vaccine has been shown in many peer-reviewed research papers to be associated with numerous infant deaths in the U.S. and Europe, multiple sclerosis and numerous chronic autoimmune disorders.

According to Child Health Safety, the U.S. government admitted as much when a Court found in favor of a plaintiff (deceased by the time the decision was made) who had developed systemic lupus erythematosus:

“Tambra Harris … filed a petition for compensation alleging that she suffered certain injuries as a result of receiving a vaccination. Among the injuries petitioner alleged that she had suffered as a result of receiving a hepatitis B vaccination was systemic lupus erythematosus (SLE) … A lump sum of $475,000.00 in the form of a check payable to petitioner as Administratrix of the Estate of Tambra Harris.”

n.b.  France removed this vaccine from the mandatory schedule while they are looking into the possible link between the Hep B vaccine and M.S in children.

Infant mortality rates regressed against number of vaccine doses routinely given:

Is there a biochemical or synergistic toxicity?

The infant mortality rate (IMR) is one of the most important indicators of the socio-economic well-being and public health conditions of a country. The US childhood immunization schedule specifies 26 vaccine doses for infants aged less than 1 year—the most in the world—yet 33 nations have lower IMRs.

Using linear regression, the immunization schedules of these 34 nations were examined and a correlation coefficient of r = 0.70 (p < 0.0001) was found between IMRs and the number of vaccine doses routinely given to infants. Nations were also grouped into five different vaccine dose ranges: 12–14, 15–17, 18–20, 21–23, and 24–26. The mean IMRs of all nations within each group were then calculated. Linear regression analysis of unweighted mean IMRs showed a high statistically significant correlation between increasing number of vaccine doses and increasing infant mortality rates, with r = 0.992 (p = 0.0009). Using the Tukey-Kramer test, statistically significant differences in mean IMRs were found between nations giving 12–14 vaccine doses and those giving 21–23, and 24–26 doses. A closer inspection of correlations between vaccine doses, biochemical or synergistic toxicity, and IMRs is essential.

Source: Hum Exp Toxicol May 4, 2011.

Herbal Holocaust

It is crazy that millions are spent on promoting & protecting drugs that can harm (adverse reactions are the 5th leading cause of death in Europe) but herbal preparations and supplements that have been used for years are to be even more restricted.

Chinese & Adeveyic medicines are worse hit, with none passed so far.  The UK has passed 100 products but Adam Smith, from the Alliance for Natural Health, describes these products as pharmaceutical versions, many of which a respectful health food store will not stock.

I predict a rise in the use of herbal tea, allotments full of calendular & herbalists running preparation courses.
See the Alliance for Natural Health for new details

European patient groups call for mandatory vaccine surveillance systems

Safety concerns at the end of EU Immunisation Week (April 23-30, 2011) have prompted European patient groups to call for mandatory surveillance systems for routine vaccines.  This would include training for GPs to recognize adverse vaccine reactions (ADRs), a campaign to boost public awareness of direct vaccine side effect reporting by patients and the immediate addition to the hospital patient admission procedure of questions on vaccine status, especially the administration of any recent vaccines.

The World Health Organisation (WHO) has supported European Immunisation Week as a chance to promote widespread vaccination.  On 21st April however, the WHO’s Global Advisory Committee on Vaccine Safety (GACVS) stated that further investigation is needed into possible links between narcolepsy and vaccination.  In 2009–2010, in Finland and Sweden, the Pandemrix swine flu vaccine caused nine times as many narcolepsy cases as expected in children.  WHO noted that narcolepsy has never before been associated with vaccines.

EFVV, the European Forum for Vaccine Vigilance, is calling on EU member states, WHO and the EU Environmental Committee for Public Health and Food safety (ENVI) to mandate surveillance systems for vaccines.  “We urgently need to establish surveillance systems that analyze diagnosis made at outpatient visits and hospitalizations for at least one year post-vaccinations so that statistically significant links can be identified and assessed for causality,” says Dr Meryl Nass, microbiologist.[1]

The gold standard of double-blind placebo testing (where the placebo is benign) is never applied to vaccines and there is never a control group in vaccine testing.  Professor David Salisbury, Director of the UK Immunization program, has confirmed to EFVV spokeswoman Anna Watson that placebos in vaccine safety tests have always been other vaccines and that control groups were considered unethical in the case of vaccines.

In the absence of double-blind trials, surveillance in the community is essential as vaccines may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women,” said Ms Watson.  “Phase IV trials, known as Post-Marketing Surveillance Trials are vital, especially considering that Adverse Drug Reactions (ADRs) are the fifth leading cause of death in Europe,” she said.

Patients can now report ADRs directly in most European countries but most people are not aware of this.  In theory, doctors and health professionals should be encouraged to complete ‘Yellow Cards’ for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or to follow equivalent procedures in their respective countries. Vaccines are however considered ‘established medicines’, so doctors are not required to report side effects unless there is a prior association[2] or effects are life-threatening.  The result is that many potential side effects from vaccines remain unreported.  “If no data is collected, it remains unknown whether vaccination increases the incidence of most diseases, particularly rare diseases. Additionally, GPs have very little training in spotting adverse drug reactions,” said Ms Watson.

Vaccine manufacturers are not liable in a civil action for damages arising from a vaccine-related injury or death so market forces are weak in this area.  It is the view of the EFVV that the Vaccine Damage Payment Fund and its European equivalents, should be calling for Mandatory Active Vaccine Surveillance to fulfill the responsibility to vaccine safety.  Parents, patients and health professionals should be supported in vaccine safety initiatives.  As vaccine programmes continue to increase, so should our vigilance say the EFVV.

[1] Dr. Nass is a board-certified internist who has authored many publications, testified before Congress, and spoken before medical organizations regarding the problems of vaccinations and Gulf War syndrome.  ‘New Adverse Reactions from Vaccines – Surveillence Needed’ by By Meryl Nass, M.D.

[2] When there is no prior association, diseases occurring in temporal relationship to vaccination are generally felt to be coincidental.  , They are therefore notgenerally reported to voluntary reporting systems like the UK Medicines and Healthcare products Regulatory Agency (MRHA) or the U.S. Vaccine Adverse Event Reporting System (VAERS).

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