Consumercidal Happenings

Even in an analysis which is relatively quite friendly to the science that tries to establish the efficacy of this vaccine, there is still much room for dissent...

The HPV Vaccine Controversy

Major uncertainties over efficacy and safety for costly vaccines that only benefit the drug giants for sure

Prof. Joe Cummins and Dr. Mae-Wan Ho

Two years ago we reported on recombinant vaccines against the human papilloma virus (HPV) infection and cervical cancer [1] (Recombinant Cervical Cancer Vaccines, SiS 29). Clinical trials had been completed on two vaccine formulations, and these are being commercially released worldwide in government sponsored vaccination programmes that target women and girls (and even boys) as young as 9 years of age in a bid to prevent cervical and anogenital cancers [2]. This has aroused a great deal of controversy, which calls for a fuller discussion.

Human papillomavirus

According to the US government’s National Cancer Institute [3], human papillomaviruses (HPVs) are a group of more than 100 viruses. Certain types cause warts or papillomas that are benign. The HPVs that cause the common warts on hands and feet are different from those that cause growth in the throat or genetial area. Some types are associated with cancer, and are called “high risk” HPVs.

Of the more than 100 types of HPVs, over 30 can be passed through sexual contact. Most HPV infections occur without any symptoms and go away without treatment over the course of a few years. However, HPV infection sometimes persists for many years, with or without causing detectable cell abnormalities.

=> Read more!

"The Power of Lard": Jello Biafra needs to post this in one of his albums...

Health department raids liposuction clinic as doctor leaves for South America

By Guy Adams in Los Angeles
Friday, 26 December 2008
Independent.co.uk Web

A leading Beverly Hills plastic surgeon claims to have found an environmentally friendly way to combine two of America's great obsessions – after converting his 4x4 to run on fat removed from clients during liposuction operations.

Alan Bittner, who founded a high-profile clinic on Rodeo Drive, the Bond Street of Los Angeles, claims to be able to power both his Ford Explorer and his girlfriend's Lincoln Navigator on biofuel converted from excess flesh from human tums, bums and thighs. "The vast majority of my patients request that I use their fat for fuel – and I have more fat than I can use," he says. "Not only do they get to lose their love handles or chubby belly, but they get to take part in saving the Earth."

Dr Bittner made his claim in a posting on the internet site lipodiesel.com, adding that he has performed roughly 7,000 liposuction operations, and that a gallon of human fat will produce roughly the same quantity of biofuel.

Scientists say there is no reason why human fat cannot be turned into biofuel, since it contains triglycerides which are no different from those found in waste animal fats that are already being used for the same purpose. However the discovery left medical regulators unimpressed. Using human medical waste to power vehicles (or indeed for any other commercial purpose) is largely illegal, and Dr Bittner's clinic has been raided by California Health Department officials. The magazine Forbes says that Dr Bittner's ability to create what he calls "lipodiesel" first came to light in lawsuits filed by several former patients, who recently accused him of allowing his girlfriend and assistant, who were both unlicensed, to carry out intricate operations.

A gallon of "lipodiesel" will give motorists roughly the same mileage as they would get from regular diesel, the magazine added. At present, most biofuel is made from a mixture of specially grown corn, and left-over beef or pork products.

Sadly, Dr Bittner is no longer around to bask in his new-found fame. His practice in Beverly Hills suddenly closed shortly after last month's raid, and he is believed to have moved to South America.

Lawyers representing several former patients are currently attempting to track him down. One of them, Andrew Besser, claims Dr Bittner's unlicensed girlfriend removed too much fat from his three clients, leaving them horribly disfigured. Dozens of other patients have complained to the State Medical Board, he added.

Dr Bittner's lawyer is yet to comment. A notice on his website claims that the doctor is currently living in Colombia.

Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation

Kristin Rising1¤, Peter Bacchetti2, Lisa Bero3*

1 School of Medicine, University of California San Francisco, San Francisco, California, United States of America, 2 Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, United States of America, 3 Clinical Pharmacy and Health Policy, University of California San Francisco, San Francisco, California, United States of America

Background

Previous studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the publication rate of efficacy trials submitted to the Food and Drug Administration (FDA) in approved New Drug Applications (NDAs) and to compare the trial characteristics as reported by the FDA with those reported in publications.

Methods and Findings

This is an observational study of all efficacy trials found in approved NDAs for New Molecular Entities (NMEs) from 2001 to 2002 inclusive and all published clinical trials corresponding to the trials within the NDAs. For each trial included in the NDA, we assessed its publication status, primary outcome(s) reported and their statistical significance, and conclusions. Seventy-eight percent (128/164) of efficacy trials contained in FDA reviews of NDAs were published. In a multivariate model, trials with favorable primary outcomes (OR = 4.7, 95% confidence interval [CI] 1.33–17.1, p = 0.018) and active controls (OR = 3.4, 95% CI 1.02–11.2, p = 0.047) were more likely to be published. Forty-one primary outcomes from the NDAs were omitted from the papers. Papers included 155 outcomes that were in the NDAs, 15 additional outcomes that favored the test drug, and two other neutral or unknown additional outcomes. Excluding outcomes with unknown significance, there were 43 outcomes in the NDAs that did not favor the NDA drug. Of these, 20 (47%) were not included in the papers. The statistical significance of five of the remaining 23 outcomes (22%) changed between the NDA and the paper, with four changing to favor the test drug in the paper (p = 0.38). Excluding unknowns, 99 conclusions were provided in both NDAs and papers, nine conclusions (9%) changed from the FDA review of the NDA to the paper, and all nine did so to favor the test drug (100%, 95% CI 72%–100%, p = 0.0039).

Conclusions

Many trials were still not published 5 y after FDA approval. Discrepancies between the trial information reviewed by the FDA and information found in published trials tended to lead to more favorable presentations of the NDA drugs in the publications. Thus, the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased.

Funding: This publication was supported by NIH/NCRR UCSF-CTSI Grant Number UL1 RR024131. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. The sponsor played no role in the design, conduct, analysis of this research, decision to submit the article, or preparation of the article.

Competing Interests: The authors have declared that no competing interests exist.

See full article here

Academic Editor: John Ioannidis, University of Ioannina, Greece

Citation: Rising K, Bacchetti P, Bero L (2008) Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation. PLoS Med 5(11): e217 doi:10.1371/journal.pmed.0050217

Received: April 28, 2008; Accepted: September 19, 2008; Published: November 25, 2008

Copyright: © 2008 Rising et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abbreviations: CI, confidence interval; FDA, Food and Drug Administration; ITT, intention to treat; LOCF, last observation carried forward; NDA, New Drug Application; NME, New Molecular Entity; NNT, number need to treat; OR, odds ratio

* To whom correspondence should be addressed. E-mail: berol@pharmacy.ucsf.edu

¤ Current address: Department of Internal Medicine, Boston Medical Center, Boston, Massachusetts, United States of America

Reform call for mental health care

* Peter Gregory
* December 9, 2008

VICTORIA leads the world in making orders to detain and treat mental health patients, a report has revealed.

The report — the first of its kind in Australia — also said patients involuntarily held or given treatment under orders made by the Victorian Mental Health Review Board often felt humiliated and degraded by the process.

Some believed they were powerless when appearing before board panels, and patients complained about a lack of access to their files and that they received little communication about their medical reports.

Unnamed respondents said in the study that the panel hearings appeared to be "rubber stamp" exercises that upheld the views of psychiatrists who had seen them.

One interviewee, referring to an annual review process for the orders, told researchers: "I feel like I'm on trial every 12 months and I already know the verdict: I'm guilty.

"How does it make me feel? Like I'm virtually a bonded slave."

The study was compiled by the Mental Health Legal Centre, which called for sweeping changes to be made to the system of deciding on involuntary care for mental health patients.

The changes included reform of hearings held at the board, a shortening of review times after orders were made, greater information access, training for panel members and clear explanations of decisions.

The report said community treatment orders were developed after the deinstitutionalisation of mental health services, which started in the mid-1980s.

"The goals of deinstitutionalisation — moving treatment from institutions to treatment in the community — are indeed admirable," it said. "Stand-alone institutions were known to be houses of horror, rife with abuse and neglect; they must never be re-created."

The report quoted comments made in October by board president John Lesser that the 5473 orders granted in 2007-08 was a higher number than in any other jurisdiction.

The figure was up on the 5099 Victorian orders made in 2005-06, and almost three times the 1995-96 result for similar orders.

The report said the orders helped ensure admissions to hospital psychiatric units were kept to a minimum, but argued that they were overused, and were sometimes made for patients who were prepared to be treated voluntarily.

Victorian Public Advocate Colleen Pearce said she would support many of the points made in the report. She said she would like to see the focus placed on prevention and recovery within the mental health system.

Representatives from the Mental Health Review Board were unavailable for comment.

Also see this link for the role that Monsanto and Bayer are taking in killing off the bee population... How stupid can corporations and governments get???

Bee lines

Albert Einstein once said that: 'If the bee disappeared off the surface of the globe then man would only have four years of life left. No more bees, no more pollination, no more plants, no more animals, no more man'.

Bees are vital to the health and wellbeing of human beings—many of our agricultural and horticultural industries would not be viable without them and food security would be threatened as a result. About one in three mouthfuls of the food we eat depends on pollination for its existence. The bee industry in Australia is worth $80 million a year but pollination contributes to around $5 billion worth of agricultural production.

While the current focus is on the US financial crisis another crisis is unfolding, the ramifications of which might prove to be just as serious. Colony collapse disorder, a phenomenon that has been called the Marie Celeste of the bee world, has been occurring there since 2006. Colonies of adult bees just disappear. Few bodies are ever found and tests show that they are full of pathogens.

The Natural Resources Defence Council in the US estimates that nearly a third of honeybee colonies have been destroyed by the syndrome and scientists do not yet know why it is occurring. Pollination is big business in the US so beekeepers there are importing honeybees in their millions from Australia to take up the slack.

So far colony collapse disorder has not had a great impact in Australia but the bee industry here, for all its importance, is under-funded, under-researched, under-valued and under attack. There are a number of threats, including inadequate quarantine facilities, disappearing native pastures, government restrictions and pests. For example, Australia is currently the only country in the world free of the Varroa mite but if it is introduced, and it is only a matter of time, it is expected to wipe out 90 per cent of wild bees and badly managed hive bees. This will seriously affect Australian farmers who will then need to pay for hive bees to pollinate their crops, adding to the cost of production and therefore of food. It is essential for Australia to maintain a viable and adequately researched industry to protect both its wild bees and hive honeybees.

Bees are insects and people tend not to like insects and think nothing of killing them in large numbers. The next time you are tempted to kill a bee, however, remember Einstein’s prediction and think again.

Source: Australia Institute Newsletter Christmas 2008 edition. http://www.tai.org.au

(NaturalNews) Major pharmaceutical company GlaxoSmithKline has been accused of pressuring poor Third World parents into enrolling their children in experimental drug trials that have led to the deaths of at least 12 infants.

The company is currently testing an experimental pneumonia vaccine on children under the age of one in Argentina, Colombia and Panama. According to the Argentine Federation of Health Professionals (Feprosa), poor Argentinean parents have been "pressured and forced into signing consent forms."

"In most cases these are underprivileged individuals, many of them unable to read or write, who are pressured into including their children," said Juan Carlos Palomares of Fesprosa.

"This occurs without any type of state control [and] does not comply with minimum ethical requirements," the federation said.

At least 12 Argentinean babies enrolled in the study have died in the past year.

In response to be criticism, Glaxo said its strict safety protocols are monitored by an independent committee, and that no one is forced to participate in the program.

"Enrollment in the trial is on a voluntary basis and trial participants are free to withdraw at any time," the company said.

But according to Julieta Ovejero, great aunt of one of the children who died, "A lot of people want to leave the protocol but aren't allowed; they force them to continue under the threat that if they leave they won't receive any other vaccine."

The vaccine trial has also drawn accusations of corruption: The trials in the Argentinean province of Santiago del Estero were authorized under provincial Health Minister Juan Carlos Smith, brother of the lead researcher in the study.

Critics such as Ana Maria Marchese, a pediatrician at the Santiago del Estero children's hospital where the study is taking place, accuse Glaxo of using Third World children as guinea pigs.

"Because they can't experiment in Europe or the United States, they come to do it in third-world countries," she said.

Sources for this story include: www.tradingmarkets.com; www.fdanews.com.

*For example, a recent Thimerosal study, "Weight of Evidence Against Thimerosal Causing Neuropsychological Deficits" was published in The New England Journal of Medicine. The inviestigotors listed no conflict of interest, but the facts do not bear this out:

Dr. Thompson - lead investigator and former Mercke employee.
Dr. Marcy consultant for Merck, Sanofi Pasteur, GlaxoSmithKline, and MedImmune.
Dr. Jackson grant recipient from Wyeth, Sanofi Pasteur, GlaxoSmithKline, and Novartis. Paid lecturer for Sanofi Pasteur and consultfor m Wyeth and Abbott. Currently, he is a consultant to the FDA Vaccines and Related Biological Products Advisory Committee.
Dr. Lieu is a consultant to the CDC Advisory Committee on Immunization Practices.
Dr. Black receives consultant for MedImmune, GlaxoSmithKline, Novartis, and Merck, and grant recipient from MedImmune, GlaxoSmithKline, Aventis, Merck, and Novartis.
Dr. Davis - consultant for Merck and grant recipient from Merck and GlaxoSmithKline.

The article in question states, "No other potential conflict of interest relevant to this article was reported." So, the authors misrepresented themselves to the journal as an independent study.

This supposed independent study reports that any child with a preexisting neurological condition, like autism, was eliminated. In other words, they eliminated the very population most at risk from exposure to Thimerosal. Any child who developed certain neurological conditions was excluded. These conditions included encephalitis and meningitis.

Children were eliminated for many reasons. One group excluded was children whose birth weight was under 2,500 grams, about 5.5 pounds. How many babies were eliminated for being underweight is not stated. Babies of this weight are hardly rare and they are not excluded from vaccinations.

The tobacco industry's old playbook is very easy to follow: manipulation of "scientific" literature and pay-(off) junk scientists to create enough reasonable doubt to allow the marketing of known poisons. Legislators who receive large contributions from pharma will be reluctant to interfere.

For the facts, read the article "A Pediatrician resigns from the AAP" in the Info section of this website. (external .pdf)

An Open Letter to President Elect Barack Obama

US Residents Please Sign the Statement (-click title url)

We, the undersigned, are very concerned about the increasing scientific evidence showing a positive association between environmental factors, such as mercury and pesticide exposure, and neuroimmune illnesses, most notably autism.

We believe that the many neurotoxins we are exposed to threaten the viability of human life on Earth and that affected children are the 'canaries in the coal mine.' Many illnesses, including breast cancer, prostate cancer, Parkinson's disease, and Alzheimer's have their origins in the rising levels of pernicious chemicals we come in contact with including, but not limited to, the contents of vaccines.

The precautionary principle calls for a zero tolerance on the use of mercury and a moratorium on organochlorine pesticides. In truth, the toxic synergy of the many chemicals humans are exposed to is under-appreciated and makes their removal from the environment a priority well beyond the precautionary principle.

Approximately 4.5 billion pounds of pesticides are applied each year in the USA. When Rachel Carson wrote Silent Spring in the early 1960's, only 400 million pounds of pesticides were used annually. Today, almost 1 out of 3 American children suffer from at least one chronic illness, and 12 million have some form of developmental disorder. The U.S. has the 4th highest incidence of childhood cancer in the world. Since the 1970's, there has been a 50% increase in childhood acute lymphocytic leukemia and a 35% increase in brain cancer. This new pediatric morbidity & mortality is not due to better diagnosis.

Little doubt remains that the trillions of pounds of hazardous pollutants that have been poured into the environment are responsible for much of the illness and death suffered by America's children. We can no longer justify inaction on the part of our government.

We call upon our new President to set a new policy course with concrete goals for the immediate reduction in exposures to known neurotoxins and carcinogens, the rapid cessation of the use of mercury in medicine, and for setting a global agenda to phase out mercury pollution in any form. At the same time, we need a global consensus that will put a moratorium on the use of dangerous pesticides and herbicides except in the most extreme circumstances.

We also recognize that the governance of medicine and science has been overly affected by corrupt corporate influences void of humanitarian concerns and focused solely on financial gain.* Therefore, it will not be a trivial task to effect change in the cavalier way we treat the environment, but the future of human life on this planet hangs in the balance. The decisions we make to rectify this environmental disaster must be done while there is still time.

Monday, Dec 15 2008
Cervical cancer jab left my 12-year-old daughter paralysed, says mother

By Daniel Martin and Rebecca Camber
Last updated at 11:42 PM on 14th December 2008

Ashleigh Cave

Concern: Ashleigh Cave, 12, has been paralysed since October after collapsing soon after having a cervical cancer vaccine jab

A mother has spoken of her fears after her daughter developed a mystery illness half an hour after receiving the cervical cancer vaccine.

Schoolgirl Ashleigh Cave collapsed shortly after she was given the jab at school and is now paralysed from the waist down.

The 12-year-old, from Aintree, Liverpool, has been confined to a bed in Alder Hey children's hospital since October 24.

And Ashleigh's 37-year-old mother Cheryl wants an investigation into the safety of the drug she blames for her daughter's illness.

'At first they tried to tell us she was imagining it because she was being bullied,' she said. 'They will not mention her illness and the vaccine in the same sentence.

'Ashleigh is angry - she does not know what is going on.'

Mrs Cave said Ashleigh was now undergoing physiotherapy to help her regain movement in her legs.
Worrying: Ashleigh with her mother Cheryl at Alder Hey hospital - she has been bed-bound in the hospital since October after collapsing during a family trip to London

Worrying: Ashleigh with her mother Cheryl at Alder Hey hospital - she has been bed-bound since October after collapsing during a family trip to London

Dr Andrew Curran, a consultant paediatrician at the hospital, said yesterday: 'I can say with complete certainty that she is demonstrating no pathological reaction to her vaccination.'

The drug safety watchdog, the MHRA, has been notified of the case. It does not believe the cervical cancer jab brought on Ashleigh's illness.

The Cervarix vaccine is currently being given to all girls aged 12 and 13 in a nationwide programme.
cancer jab.jpg

It guards against infection by the sexually transmitted disease HPV, which causes 70 per cent of all cases of cervical cancer.

Mass vaccination will save around 700 lives a year, experts say.

Jackie Fletcher

Alert: Jackie Fletcher of anti-vaccine organisation Jabs wants the HPV vaccine programme stopped

Although the cancer does not usually strike until middle age, the jab has to be given to girls before they start having sex.

This has led anti-vaccine groups to claim it will encourage promiscuity.

The school vaccination programme followed clinical trials in 2005 on more than 18,000 women under the age of 26.

But critics have claimed the five-year study was too short and not enough pre-pubescent girls were involved in it.

After separate clinical trials, the U.S. started using a similar vaccine called Gardasil.

Since then there have been dozens of 'adverse events' reported, including 30 deaths, as well as cases of Guillain-Barré syndrome - a little-understood malfunctioning of the immune system which can cause paralysis.

A spokesman for the MHRA said: 'Guillain-Barré syndrome naturally occurs in the population.

There is no good evidence to suggest that the Cervarix vaccine can cause it.'

But Jackie Fletcher, of anti-vaccine organisation Jabs, said: 'We should halt the HPV vaccine programme in the UK until we get to the bottom of whether this poor girl's paralysis was caused by the vaccine or not.'

More evidence to profound consciousness in animals. Think about this next time you are chowing down on a hamburger.

http://www.sonnyradio.com/herodog.html

"An oldie but a goodie" on Additive 120...

Insect-derived Coloring Causes Severe Allergic Reactions

Food colorings that cause severe allergic reactions should be disclosed clearly on labels or possibly banned, a national health-advocacy group is telling the Food and Drug Administration.

The colorings come in two forms, cochineal extract or carmine. Both are derived from female cochineal beetles, which are raised in Peru, the Canary Islands, and elsewhere. They provide a pink, red, or purple color to foods ranging from ice cream and yogurt to fruit drinks and the aperitif Campari, as well as to pharmaceuticals and cosmetics.

In the past several years, doctors in Michigan, Switzerland, and France have proven that the colorings can cause allergic reactions, including sneezing, asthma, and anaphylactic shock. The prevalence of allergic reactions is not known.

The Center for Science in the Public Interest (CSPI), a nonprofit organization based in Washington, today petitioned the FDA to either revoke approval of the colorings or require that they be clearly labeled by name. Currently, they may be declared on labels as "artificial color" or "color added."

CSPI is well known for its criticisms of olestra, saccharin, sodium nitrite, and several other controversial food additives.

"A coloring that can cause anaphylactic shock in sensitive individuals should be required to be listed specifically on labels," said Dr. James Baldwin, clinical assistant professor at the University of Michigan School of Medicine.

Michael F. Jacobson, Ph.D., executive director of CSPI, said, "No one should have to experience a life-threatening anaphylactic reaction just because they ate an artificially colored food. Food manufacturers should switch to other colorings."

Jacobson added, "Americans shouldn’t have to repeat their experience with sulfite preservatives, which also caused anaphylactic reactions. Fifteen years ago, consumers died while the FDA delayed acting on CSPI’s petition to ban dangerous uses of sulfites." The FDA ultimately banned the most dangerous uses of sulfites and set strict limits on other uses.

Many vegetarians, Jews, and others who observe dietary restrictions have been surprised to discover that a coloring derived from insects is used in food. To protect those consumers, CSPI urged the FDA, if it didn’t ban carmine and cochineal extract, to require that labels indicate that the colorings are derived from insects. CSPI recommended that ingredient lists declare: "Artificial color (carmine/cochineal extract (insect-based))."

CSPI urged allergists who have had patients allergic to carmine or cochineal extract to call its Carmine Allergy Clearinghouse at 1-888-653-7872.