Pfizer execs to stand trial for cover-up of drug trial results

By Ethan A. Huff

(NaturalNews) Four former executives at Pfizer Inc., the world’s largest drug company. — Henry McKinnell, John LaMattina, Karen Katen, Joseph Feczko — as well as Gail Cawkwell, Pfizer’s current Vice President of Medical Affairs, will all face trial for allegedly concealing the unfavorable results of drug trials involving Celebrex and Bextra.Courthouse News Service (CNS) reports that U.S. District Judge Laura Taylor Swain has denied requests made by defendants to dismiss the case, which means all five individuals will be held to account for their actions.

The securities class-action lawsuit, which was filed by the Teachers Retirement System of Louisiana (TRSL) on behalf of Pfizer stockholders, alleges that the five defendants violated federal securities laws by concealing the results of studies involving Celebrex, a COX-2 inhibiting anti-inflammatory drug, and Bextra, a non-steroidal anti-inflammatory drug (NSAID) that was pulled from the market in 2005.

According to the suit, the five defendants made misleading statements in their public filings about the drug trials, and also omitted important information that exposed both Celebrex and Bextra as being dangerous.

Read the entire article here.

Health Authorities Now Admit Severe Side Effects of Vaccination Swine Flu, Pandemrix and Narcolepsy

By Karin Munsterhjelm-Ahumada, M.D.

OMNS

(OMNS, March 20, 2012) The swine flu pandemic of 2009 was caused by a type A influenza (H1N1) virus. This virus was originally referred to as “swine flu” because many of the genes of this new virus were very similar to influenza viruses that normally occur in pigs in North America. The H1N1 virus is genetically similar to the 1918 pandemic virus, as determined from victimes of the latter who were buried, and later disinterred, in Svalbard. It was responsible for most of the outbreaks up until 1956 and then disappeared.

However, this new virus was actually quite different from the typical swine flu viruses. This virus first caused illness in Mexico and the United States in March and April, 2009. This novel H1N1 flu spread from person to person, unlike typical swine flu. In 2009 vaccines were being developed for the prevention of swine flu in humans. http://www.medterms.com/script/main/art.asp?articlekey=99584

On 11 June 2009, the World Health Organization (WHO) declared that the swine flu had developed into a full scale world epidemic – a pandemic alert to Phase 6. Margaret Chan, the Director-General of WHO, commented on the situation in a somewhat ambiguous way. While stressing that the swine flu had reached a serious pandemic level, she declared later in the same statement that the illness seemed to be mild and that most of the patients would recover without medical intervention. http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html

The world chose to listen to the first part of her message.

Two pharmaceutical companies GlaxoSmithKline (GSK) and Novartis had, under considerable time pressure, developed a vaccine against the swine flu. Since the cultivation of an adequate amount of virus to generate the vaccine requires time, GSK and Novartis decided to formulate a weaker vaccine but strenghten it with an adjuvant that contains squalene. Immunologic adjuvants are substances, administered in conjunction with a vaccine, that stimulate the immune system and increase the response to the vaccine. http://www.who.int/vaccine_safety/topics/adjuvants/squalene/questions_and_answers/en/ Although squalene is a natural substance found in methabolic pathways of the body, its inclusion in a vaccine is controversial and it is not in use in the USA.

On 25 September 2009, the European Medicines Agency (EMEA) approved Pandemrix, the swine flu vaccine produced by GSK and Focetria produced by Novartis. http://justthevax.blogspot.com/2009/09/eu-approves-gsk-pandemrix-and-novartis.html The vaccine would be ready for use that October.

In Sweden, Finland, Norway and Iceland, the authorities explicitly set the goal of vaccinating the entire population http://www.svd.se/nyheter/inrikes/massvaccinering-raddade-sex-liv_6851143.svd. In this respect, it is of interest that the governments of these countries, already before the outbreak of the swine flu, had concluded an agreement with GSK, according to which they were assured the delivery of pandemic vaccines, if needed. In addition, the contract stipulated that, in a situation characterized as a pandemic by the WHO, the same Nordic countries would have ten days to decide whether or not to accept delivery of the vaccine in question. Hence, the purpose of the agreement was to assure that the entire populations of these countries would receive vaccinations. Finally, the contract protected GSK from any claim for financial compensation in case the delivered vaccine would have any side effects.

When WHO declared the swine flu to be a Phase 6 pandemic, the agreement referred to above was automatically activated.

Mass vaccination started in Finland and Sweden in October 2009. In order to cover the largest possible percentage of the population, the authorities initiated an enormous public relations campaign, which could be described in terms of a “moral persuasion.” Solidarity became the slogan: “Be vaccinated to protect your fellow citizens.” Those who questioned the vaccination program (small groups of vaccine opponents or just people who were hesitant) were looked upon with disapproval.

In contrast to these vaccine – enthusiastic countries, the politics of vaccination within the rest of the European Union varied immensely among its member states. Poland, for example, decided not to buy vaccines at all due to the strict agreement conditions required by the pharmaceutical companies. Denmark’s order covered only “risk groups”. http://www.svd.se/nyheter/inrikes/svd-granskar-sveriges-vaccinering-mot-svininfluensan_6843475.svd

The expected second wave of the influenza never appeared. The epidemic gradually declined during the first half of 2010. The same year, on 10 August, WHO officially declared the end of the epidemic. The European Center for Disease Prevention and Control (ECDC) stated that the swine flu was less dangerous and had a lower mortality rate than the seasonal influenza. Thus, apparently the swine flu would not have been a dangerous epidemic even without the mass vaccination. Interestingly, also that same year, vitamin D was shown to prevent influenza in children. (1)

In Sweden, 60% of the population had been vaccinated, while in Finland 50% was covered. In contrast, the figures in Germany and Poland were only 8 and 0% respectively. In the history of Swedish health care this pandemic campaign amounted to one of the most expensive ever. Enormous amounts of taxpayer money were at stake. http://www.svd.se/nyheter/inrikes/svd-granskar-sveriges-vaccinering-mot-svininfluensan_6843475.svd

Meanwhile, the media had become silent on this issue ; there was no further discussion about the swine flu anymore.

Then the blow came:

“The absolutely worst thing that could happen,” commented Richard Bergström, the Director – General of the European Federation of Pharmaceutical Industries and Associations, EFPIA. “The worst nightmare of both the industry and the health authorities is an illness that turns out to be mild, while the vaccine that was supposed to prevent a dangerous epidemic causes a severe side effect that was previously unknown.” http://www.kostdemokrati.se/nyheter/files/2012/02/SvD-sid-14-19.pdf

In August 2010, Finland reported an increased occurrence of narcolepsy in children and youngsters vaccinated with Pandemrix. On 1 September 2010, Finland stopped all Pandemrix vaccinations. http://articles.mercola.com/sites/articles/archive/2010/09/10/swine-flu-vaccine-may-have-caused-narcolepsy.aspx

Narcolepsy is a severe chronic neurologic disease that not only results in a disabling fatigue, which typically results in the patient falling asleep anywhere and at any time. It might also lead to panic attacks and a state of exhaustion. For many, the worst consequences are the symptoms of cataplexy. This condition causes the narcolepsy patient, when expressing strong feelings such as laughter or crying, to suddenly lose muscular control. The legs give way, speech gets slurred, the gaze goes unfocused and the person gives the impression of being drunk. In some patients, frightening hallucinations appear when falling asleep or waking up.

On 1 September 2011, the Finnish National Institute for Health and Welfare (THL) admitted, that for Finnish children and youngsters age 4-19, there was a new and obvious connection between Pandemrix and narcolepsy. As stated in THL’s press release, “The increased risk associated with vaccination amounted to six cases of narcolepsy per 100,000 persons vaccinated in the 4-19 age group during the eight months following vaccination. This was 12.7 times the risk of a person in the same age group who had not been vaccinated.” http://www.thl.fi/en_US/web/en/pressrelease?id=26352 This statement was made almost exactly two years after the THL’s earlier statement made in the midst of the swine flu hysteria that everyone should be vaccinated with Pandemrix and that it would be safe. In that original statement, the director of the THL emphasized that the squalene adjuvant could increase the side effects of the vaccine to some extent. However, he stated, these side effects would not be dangerous. http://www.tohtori.fi/?page=5833192&id=0169960

In Sweden, at least 150 children are now suffering from narcolepsy caused by Pandemrix vaccine. In Finland, the number is approximately 100. In both countries the number is probably growing. Narcolepsy is a disease with lifetime consequences, and the risk that Pandremix may have caused other neurological illnesses has not yet been excluded. Many have already began to compare this tragedy with the thalidomide catastrophe. http://www.svd.se/nyheter/inrikes/medicinsk-tragedi-med-ett-absurt-slut_6861775.svd

No European countries had a particularly high rate of deaths due to the swine flue. Germany had the same death rate as Sweden, which was 0.31/100 000, although Sweden vaccinated 60% and Germany only 8%. This implies that the vaccine did little to prevent deaths. The responsible authorities have not yet commented on this matter of fact. http://www.svd.se/nyheter/inrikes/massvaccinering-raddade-sex-liv_6851143.svd

Last year the Finnish government promised full compensation for those who have developed narcolepsy as a consequence of the vaccination. http://www.bloomberg.com/news/2011-10-05/finnish-government-to-compensate-pandemrix-narcolepsy-victims.html. While Sweden did, indeed, follow the Finnish THL in admitting the connection between the vaccine and the disease, the Swedish authorities have not yet decided whether and how to provide appropriate compensation.

In February 2012, Svenska Dagbladet, a widely read newspaper in Sweden, presented an informative and accurate series of articles on this theme. They describe some of the affected children narrating how difficult it is to live with narcolepsy http://www.svd.se/nyheter/multimedia/artikel_6840743.svd

According to the authorities, much research is still underway concerning the details of the vaccine injury. Taking the pressure from the public and the affected families into account, it will be difficult for them to avoid carrying out a thorough investigation. Let’s hope so.

References:

1. Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010 May;91(5):1255-60.

[Note: This article is reprinted in its entirety with the kind permission of the Orthomolecular Medicine News Service. You may subscribe to their newsletter at no charge here -  http://orthomolecular.org/subscribe.html. You may also view their archives at http://orthomolecular.org/resources/omns/index.shtml.]

New Autism Research Program: Big Pharma Profit Center with Taxpayers’ Help

Post from Gaia Health

Taxpayer funds?

The European Union has partnered with pharmaceutical corporations and Autism Speaks for the sole purpose of developing drugs to cram down the throats of autistics. Rather than doing honest research into the causes of this devastating condition, money is being poured into finding ways to suppress its symptoms.

A new organization, European Autism Interventions – A Multicentre Study for Developing New Medications  (EU-AIMS), has been formed to benefit Big Pharma’s bottom line at the expense of autistics. The plan is to simply accept that autism is here, in spite of its nonexistence or near nonexistence a few decades ago. The organization has no interest in autism prevention.

Project Goals

EU-AIMS states its goals as :

  • To develop and validate “translation research approaches” for the advancement of novel therapies.
  • To set new standards in research and clinical development to aid the drug discovery process.
  • Development of sites across Europe for clinical trials on autism, and create an “interactive platform for ASD professionals and patients”.

Let’s examine those goals:

Translational Research

Translational research is a new concept that’s being pushed by Big Pharma, as can be seen in this definition given by the Wellcome Trust ,

Translational research helps turn early-stage innovations into new health products, advancing the innovation to the point where it becomes attractive for further development by the medical, pharmaceutical or biotechnology industries.

In other words, the goal of translational research is simply to bring more products to market more quickly. it is an attempt to streamline development of pharmaceutical drugs and bring them through the approval process more rapidly.

One must ask why this is a focus for treatment of autism. And why do they presume that it’s beneficial to autistics? The reality has been that drugs used for treating autistics, even though they’ve gone through a more extensive approval process, have proven to be harmful, not helpful. Why would an organization whose goal one would expect to benefit autistics choose to push such a plan?

Read the entire article here.

CREW With Advocacy Groups Ask FTC to Investigate Anti-Competitive Practices of Vaccine Makers

By David Merchant

WASHINGTON–(BUSINESS WIRE)–Today, Citizens for Responsibility and Ethics in Washington (CREW), the National

Anti-competitive practices?

Legislative Association on Prescription Drug Prices (NLARx), the Campaign for America’s Future (CAF), and the U.S. Public Interest Research Group (U.S. PIRG) called on the Federal Trade Commission (FTC) to immediately investigate the vaccine bundling practices of Sanofi Pasteur and Merck, which make it harder for pediatricians to use the best vaccines for children. Sanofi and Merck force pediatricians to buy vaccines in a bundle at a discount, or pay exorbitantly high prices to purchase vaccines individually. As a result, some children may not receive the vaccines most suitable for them.

“When parents take their kids to the doctor, they expect the best medical care available, not the care dictated by drug companies seeking to maximize their profits. Basically, doctors are asked to make a choice they can’t refuse.”

CREW Executive Director Melanie Sloan stated, “When parents take their kids to the doctor, they expect the best medical care available, not the care dictated by drug companies seeking to maximize their profits. Basically, doctors are asked to make a choice they can’t refuse.”

CREW first wrote to the FTC about this issue in 2010, but a whistleblower has now provided new details about the practice.

Read the entire article here.

Merck develops drug that deals with its own side effects

By JOEY NOVICK

WHAT EXIT?

SATIRE

Merck: Satire

“Lexmora©, this little yellow pill, makes people feel the same way before and after it is taken,” said Merck CEO Kenneth C. Frazier.

Lysusproteun (tradename – Lexmora©), is a prescription-only drug which addresses a wide range of ailments. These include nausea, dry mouth, vomiting, excessive sweating, headache, tremor, drowsiness, inability to sleep, sexual dysfunction, anal leakage, and severe gaseous bloating. For patients with heart problems or those with diabetes, there may be an additional benefit of addressing dizziness, tingling sensations, tiredness, vivid dreams, and irritability or poor mood.

The side effects of Lexmora© are nausea, dry mouth, vomiting, excessive sweating, headache, tremor, drowsiness, inability to sleep, sexual dysfunction, anal leakage, and severe gaseous bloating. For patients with heart problems or those with diabetes, there may additional side effects of dizziness, tingling sensations, tiredness, vivid dreams, and irritability or poor mood.

Ask your doctor about Lexmora©, if you have any of the above symptoms.

Read the entire article here.

Gardasil Study Funded by Merck: Are Results Biased? CBCD Raises Doubts

Yahoo News

Center for the Biology of Chronic Disease

This study was funded by Merck, the manufacturer of Gardasil. Many scientific papers argue that the public should not trust any industry funded research.

Rochester, NY (PRWEB) February 08, 2012

The Center for the Biology of Chronic Disease (CBCD) has learned that Merck recently funded a study conducted by Dr. Chun Chao from Kaiser Permanente. USA Today reported: “Study: No link between HPV vaccine and autoimmune disorders” on January 28, 2012. In the opening paragraph, the story says that “The human papillomavirus (HPV) vaccine Gardasil does not trigger autoimmune disorders.”

Should the reader believe the report? Is it possible that the researchers, who conducted the study, are biased?

According to USA Today, this study was funded by Merck, the manufacturer of Gardasil. Many scientific papers argue that the public should not trust any industry funded research.

For instance, a paper published in the Indian Journal of Medical Ethics says that, “Empirical research indicates that much of the evidence required for the practice of evidence-based medicine cannot be trusted. The research agenda has been hijacked by those with vested interests within industry and academia, determining what research is funded and how it is done and reported.” It went on to say, “Many well-reported randomized controlled trials are designed to deceive by their choice of comparators and outcomes….”

Another paper published in the American Journal of Orthopedics says, “…industry-sponsored clinical trials have traditionally been associated with more positive results.”

Yet another paper published in Science and Engineering Ethics says, “Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship.”

Finally, a paper in PLoS ONE quotes Dr. Daniele Fanelli as writing, “about 2% of scientists admitted to have fabricated, falsified or modified data or results at least once –a serious form of misconduct by any standard– and up to one third admitted a variety of other questionable research practices including “dropping data points based on a gut feeling”, and “changing the design, methodology or results of a study in response to pressures from a funding source”.

What do these papers say in simple terms?

When a company pays for the study, beware. The results usually show what the company wants them to show. In other words, those who have the gold, somehow, determine the results.

In this case, the company with the gold is Merck, and the product is Gardasil. It is certainly within Merck’s interests to disprove any connection between their vaccine and autoimmune disorders. And lo and behold! The results promote Merck’s interest.

Merck’s funded study relies on correlation, a weak approach at best. The CBCD would like to suggest another method for answering the question about Gardasil and disease. It is called the mechanistic approach. In simple terms it is answering the following question, “If Gardasil causes disease, what is the biological mechanism that leads from getting the Gardasil shot to becoming ill?”

Dr. Hanan Polansky’s discovery of “Microcompetition with Foreign DNA” provides such a biological mechanism. Microcompetition explains how the DNA fragments found in the Gardasil vaccine can cause major diseases, including autoimmune disorders.

Dr. Hanan Polansky is the author of the highly acclaimed “Purple” book, entitled Microcompetition with Foreign DNA and the Origin of Chronic Disease. In his book he explains how foreign DNA fragments can cause many major diseases without damaging (mutating) the human DNA.

“Not only does the book present a strong theory to unify the cause of many diverse disease states, the book itself represents an aspect lacking in the field of medical science, an attempt to unify observations into coherent theories.” – Q. Ping Dou, PhD – Co-Leader, Prevention Program, Barbara Ann Karmanos Cancer Institute, and Professor, Department of Pathology, School of Medicine, Wayne State University

The book has been read by more than 5,000 scientists around the world, and has been reviewed in more than 20 leading scientific journals such as the Archives of Virology and the European Journal of Cancer.

The CBCD encourages biologists, virologists, geneticists, scientists and the general public to obtain a copy of Dr. Hanan Polansky’s book and read it. The book is available as a free download from the CBCD website.

(http://www.cbcd.net)

The CBCD endorses Dr. Polansky’s theory, and invites the media, scientists, and the general public to contact us on this issue.

For more information on the Center for the Biology of Chronic Disease, or to schedule an interview with Dr. Polansky, please visit http://www.cbcd.net or call 585-250-9999.

References:

Tharyan P. “Evidence-based medicine: can the evidence be trusted?” Indian Journal of Medical Ethics, Oct., 2011

Lexchin J. “Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications.” Science and Engineering Ethics, February 15, 2011

Fanelli D. “How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data.”PLoS ONE, May 29, 2009

Khan SN, Mermer MJ, Myers E, Sandhu HS. “The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.” American Journal of Orthopedics (Belle Meade N.J.) Dec., 2008

The Center for the Biology of Chronic Disease (CBCD, http://www.cbcd.net) is a research center recognized by the IRS as a 501(c)(3) non-for-profit organization. The mission of the CBCD is to advance the research on the biology of chronic diseases, and to accelerate the discovery of treatments for these diseases.

The CBCD published the “Purple” book entitled “Microcompetition with Foreign DNA and the Origin of Chronic Disease” written by Dr. Hanan Polansky. The book presents Dr. Polansky’s highly acclaimed scientific theory on the relationship between the DNA of latent (chronic) viruses and the onset of chronic diseases. Dr. Polansky’s book is available as a free download from the CBCD website.

We invite biologists, virologists, and scientists everywhere to download Dr. Polansky’s book here: http://cbcd.net/.

###

John S. Boyd, PhD
CENTER FOR THE BIOLOGY OF CHRONIC DISEASE
(585) 250-9999
Email Information

 

Read Full Article…

GSK fined after over vaccine trials; 14 babies reported dead

Buenos Aires Herald

February 3, 2012

By Javier Cardenal Taján
BuenosAiresHerald.com staff

GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies.

Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.

The charges included experimenting with human beings as well falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of seven babies died in Santiago del Estero; five in Mendoza; and two in San Juan.

Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies were being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”

“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

 

Read Full Article…

Health ministry yet to initiate action on violations in trials of HPV vaccine in AP and Gujarat

By Joseph Alexander, New Delhi

Ethics Violations?

Even after several months since the expert committee found irregularities in the clinical trials of Human Papilloma Virus Vaccine (HPV vaccine) that allegedly caused deaths of a few trial subjects, the authorities are still sitting on the report and failed to initiate any punitive action.

According to a status report on the violations in clinical trials during the past few years, the controversial trial was listed by the Health Ministry among the violations but said ‘the report was still under examination.’

“This was a phase-IV post licensure clinical trial. The trial was initiated by PATH (Programme for Appropriate Technology in Heath), an NGO. The Indian Council of Medical Research (ICMR) and the State Governments of Andhra Pradesh and Gujarat were the collaborating partners. 14091 girls received the vaccine in Andhra Pradesh whereas 10686 girls received the vaccine in Gujarat,” said the report.

“Media reported death of 7 girls during the trial. The trial was suspended by ICMR on 7th April 2010. A Committee was appointed to enquire into the alleged irregularities in the conduct of studies using HPV vaccine by Path in India. It reported certain discrepancies in the conduct of the trial. The PATH submitted clarifications in respect of irregularities observed in the conduct of trial which is under examination,” it said.

After the expert panel submitted the report, the government in May last had allowed the third phase of clinical trials in India but without further vaccinations, notwithstanding the demands by public interest organisations and political leaders to initiate stern action.

Read the entire article here.

Investigation: The Meningococcal Gold Rush

By Barbara Sumner Burstyn & Ron Law

new-zealand

Vaccine Fraud?

EXECUTIVE SUMMARY: New Zealand’s meningococcal disease story, as unravelled through analysis of previously secret documents obtained under the Official Information Act, reveals that the New Zealand government, media and public have been misled and manipulated by officials, advisors and scientists alike.

As a result of this manipulation, the government has committed an unprecedented 200 million taxpayer dollars to a mass vaccination experiment of 1.15 million New Zealand children with an untested and experimental vaccine. Despite being reassured by a bevy of pro-vaccine and vaccine manufacturer sponsored experts and none-less than the Minister of Health herself that the MeNZB(tm) vaccine is thoroughly tested and proven to be safe and effective, we reveal that Chiron’s MeNZB(tm) vaccine was never used in the trials used to approve its license. We reveal that despite assurances, there is no evidence that the MeNZB(tm) vaccine will actually work as promised.

We believe that the magnitude of policy, regulatory and scientific misconduct is such that not only should vaccination with this vaccine be halted forthwith, but that the meningococcal vaccination program should be independently audited and the circumstances surrounding the development and implementation of the program subjected to a full Royal Commission of Inquiry.

Read the entire story here.

Premature Babies Used As Lab Rats In Manipulated Vaccine Trials

By Christina England

While reading the results of a vaccination trial on premature babies funded by GlaxoSmithKline, I noticed something was not quite right.

The trial, whilst sickening in itself, was testing out the rotavirus vaccine on a group of 988 premature babies ranging between 27 weeks and 36 weeks.

The paper reporting the trial was published on the ‘Pediatric SuperSite’ and was entitled ‘Human rotavirus immunogenic, well-tolerated for preterm infants’ by Felix Omenaca MD. PhD, and colleagues (1) The paper stated the following:

“The researchers grouped preterm infants by ages — infants born at gestational ages 27 to 30 weeks and those born at 30 to 36 weeks. They administered rotavirus vaccine (RIX4414, GlaxoSmithKline) in two doses to 658 preterm infants, and 330 received a placebo along with routine vaccinations, including diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type B and poliovirus. Infants from France and Spain also received Streptococcus pneumoniae concomitantly; infants from Portugal and Spain also received Neisseria meningitides.

The researchers then asked parents/guardians to report adverse effects, and they noted no statistically significant difference in the reporting of severe adverse reactions in the vaccine or placebo group (5.1% and 6.2%, respectively). Unsolicited adverse effects, which included fever of more than 39.5·C, six or more bouts of diarrhea per day, three or more episodes of vomiting per day, appetite loss and irritability, were reported in 29.3% of preterm infants in the vaccine group and 40.7% in the placebo group. (own emphasis)

The problems I see are as follows:

  1. All the infants were given multiple vaccinations, therefore, there was no control group.
  2. Of a group of 988 children, approx 2/3 were given the vaccine for rotavirus and 1/3 were given the placebo, then the researchers compared the results like for like. This cannot be done because one group is significantly larger than the other.
  3. Because all of the infants received multiple vaccinations it is impossible to tell which vaccine if any caused the side effects.

Read the entire article here.

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