Vaccine Companies Investigated For Manslaughter

A formal investigation has been launched by French authorities against two managers from drug companies GlaxoSmithKline and Sanofi Pasteur. A second investigation for manslaughter has also been opened against Sanofi Pasteur MSD.

The investigations are in response to allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used between 1994 and 1998.

During this time, close to two-thirds of the French population, and almost all newborn babies, received a hepatitis B vaccine. The vaccination campaign was halted after concerns rose over the shotʼs side effects.

Thirty plaintiffs, including the families of five people who died after the vaccination, have launched a civil action in the case against the drug companies.
Sources:

* Reuters February 1, 2008

Action Against The Guilty In Vaccine Trial Death

The Drug
Controller General of India (DCGI) has found “glaring gaps” in the clinical trials of the US-based drug maker Wyeth's
advanced pneumonia vaccine which led to the death of an infant and said action will be taken against the guilty this week.

"We have found that there were glaring gaps in the clinical trial conducted for Wyeth's 13-strain variant pneumococcal vaccine. The audit report is ready and we expect to take an appropriate punitive action by this week," DCGI Dr Surinder Singh said.

Wyeth had given the clinical research contract to the domestic firm GVK Biosciences. Clinical trials took place at St John's National Academy of Health Sciences, Bangalore.

An official in the DGCI office, who didn't wish to be named, said notices would be served to the two firms and the hospital soon.

When contacted, Wyeth denied any wrongdoing. “Wyeth-sponsored trials in India adhere to the same rigorous standards as Wyeth-sponsored clinical trials in any other country,” Wyeth director (clinical research & development) India region, Dr Durga Gadgil said.

Explaining the cause of the child’s death, she said, “The child had developed a viral infection. Experts found that this unfortunate death was not associated with any of the vaccines the child received as part of the study and the trial followed all study-related protocol. At the time of the enrolment there was no detectable abnormality in the child.”

According to her the child died due to some unrelated complications after seven days of administering the vaccine. GVK Biosciences declined to comment.

The drug quality regulator didn’t disclose details about the report and the action expected to be taken against the guilty. “We can’t comment on the quantum of the punishment at present as this is the very first case being audited by us,” Dr Singh said.

The phase-III trial was the final stage before the medicine could be launched in the domestic market. Faced with criticism, the government had initiated the audit of the clinical trial. This is the first audit in the country even as India is a hub for various types of clinical trials.

Source: The Economic Times, 19th January 2009.

Teenage Girls Sue Over Cervarix Vaccine

A GROUP of British teenagers has launched the first legal action
against the makers of a controversial cervical cancer jab.

They have suffered symptoms ranging from paralysis and seizures to
fatigue and muscle aches since being given the Cervarix vaccine.

The jab is being given to girls from the age of 11 in a huge
nationwide programme launched last September.

It is claimed it will give 70 per cent protection from the disease to
every girl under 18 by 2011.

But a growing number of parents and medical experts believe the
vaccine may have alarming side effects.

Among them is Sophie Vickery, 35, from Honiton, Devon, who is
convinced the drug has turned her daughter Hattie from a happy 13-year-
old with a love of music into an invalid plagued by paralysis,
breathing problems and lethargy.

Twelve-year-old Ashleigh Cave has been in hospital in Liverpool since
last October suffering paralysis in her legs.

She collapsed five times within 48 hours of getting the jab. Other
girls have suffered breathing and visual problems.

The case has been taken up by London solicitor Peter Todd, who
specialises in vaccine-related claims.

He said: "If you are immunising a large population it is likely a
small number will have a serious adverse reaction. These people are
innocent, but may become seriously disabled as a result of the jab. I
want to see justice for them."

So far there have been more than 1,300 reported reactions to the jab
in the UK.

Critics say its sister vaccine Gardasil, used in the US for nearly
three years, is linked to almost 12,000 reactions including 32 deaths,
paralysis, seizures, blood clots, heart attacks, sight problems and
blackouts.

London GP Richard Halvorsen, author of The Truth About Vaccines, said:
"It has been introduced far too quickly. I would not recommend girls
are vaccinated until we know more."

Biologist Dr Mae Wan Ho, who has published a recent report on the jab,
said: "I would ban this vaccine. It has low effectiveness and it is
also subjecting people to the risk of long-term side effects."

A spokeswoman for GlaxoSmith-Kline, which makes Cervarix, said:
"Cervarix had to undergo rigorous testing with large numbers of people
in numerous clinical studies."

She said more than 70,000 doses of the firm's vaccine had been given
in trials and recipients had been monitored for more than six years.
Clinical studies had shown Cervarix was "generally well tolerated".

Source: The Express, 19th April 2009.

Court Reverses Decision On Boys DPT Vaccine Injury and Gives Compensation

The National Law Journal recently reported on a DPT (diphtheria, whole-cell pertussis, tetanus) vaccine case that was reversed on appeal, reports CBS News investigative correspondent Sharyl Attkisson.

The Federal Circuit Court decided that a boy vaccinated at 8 weeks is entitled to compensation, after all.

According to the claim, the vaccination caused a seizure disorder that led to the child, Enrique Andreu, developing a low IQ and language and developmental delays. The Appeals Court (Federal Circuit Court) decided the Special Master (Judge) in the original decision “erroneously… determined that the testimony of Petitioner's physicians was insufficient to establish ‘a logical sequence of cause and effect’ leading to Petitioner's vaccine-related injury; and (erroneously) imposed upon Petitioner an elevated evidentiary burden, requiring conclusive proof in the medical literature linking Petitioner's symptoms to the vaccine at issue.”

In plain language, the Appeals Court sent a message to the Special Masters in Vaccine Court: that they are (at times) interpreting the evidence too harshly against the Plaintiff. In the words of the Plaintiff’s attorney: the Special Masters “require a burden of proof that’s just too high.” The government which defended the case has not made comment.

Source: CBS News, 26th June 2009.

Doctor is Suing CDC and Taiwan DOH After H1N1 Vaccine Killed His 7 Year old Son

A gynecologist is planning to sue the Centers for Disease Control over the death of his seven-year-old son after receiving the A (H1N1) flu virus vaccine, reports said Tuesday.

The CDC denied there was a link between the two and said it would continue its present inoculation campaign.

The Taichung boy, surnamed Liu, did not have any history of medical problems before being immunized at school on November 19, said Chang Yao-tsung, an opposition Democratic Progressive Party member of the Taichung City Council speaking on behalf of the child’s parents.

His health started deteriorating the following day, with red blotches appearing on the sole of his feet. The boy’s father, a gynecologist only mentioned with his surname Liu, took him to a local private clinic where he was told the problem might be a skin disease or an allergy provoked by the vaccine.

The father thought the rashes might disappear after taking medicine for two weeks, but instead they spread all over his body, according to Chang.

On November 28, Liu also contacted the CDC, which denied the problems were caused by the vaccine, Chang said.

Desperate for a solution, Liu checked his son into a hospital and transferred him twice, looking for more tests and expensive treatments. Some doctors said there was a problem with his son’s immune system.

The seven-year-old officially died of sepsis Monday, more than a month after being inoculated.

Since the boy held United States citizenship, the American Institute in Taiwan also sent a representative to talk to the father and provide assistance if requested, Chang said.

CDC Director-General Steve Kuo said its experts had investigated the case and come to the conclusion that the boy’s death was not related to the vaccine.

He said the CDC would respect whatever decision the boy’s father took, filing for compensation or taking legal action.

A total of almost 4.8 million people had been vaccinated so far, according to CDC statistics.

Including the boy, a total of four deaths were recorded following inoculation, including men aged 82 and 50 respectively who had difficult health histories, and a high school student, reports said.

Five pregnant women were reported with problems ranging from miscarriage to a stillborn infant.

Of the 331 lighter cases, 43 percent were dizzy after being inoculated, 20 percent registered a fever, 18 percent felt ill, 17 percent had a headache and 11 percent vomited, according to CDC data.

Source: Taiwan News, 22 December 2009.

Italy Launching Parliamentary Investigation into Swine Flu Saga and 'Powerful Pharmaceutical Companies'

There is going to be a parliamentry investigation into the mass purchase of H1N1 vaccines in Italy.

Maurizio Gasparri, MP, said that he believed the decision to purchase millions of doses of vaccine was influenced by powerful pharmaceutical companies.

H1N1 flu turned out to be like seasonal flu and unusually light in its course and the huge stocks of vaccine bought by the government had not been used because the majority of Italians did not take the vaccine.

"It's hard not to think about speculative maneuvers in a global dimension by unscrupulous pharmaceutical multinationals, powerful enough to influence the information that with its alarmist tone is that of sharks" - said Senator Gasparri.

He added he did not want them to escape with illegal profits.

We must determine whether the person who earned no reason, may return the profits accumulated through the lies - told an Italian politician.

Source: http://wiadomosci.onet.pl/2104314,12,wlochy_nowa_grypa_to_blef,item.html

French Health Minister to be Questioned About the Evolution of the Swine Flu Scare

The Health Minister Roselyne Bachelot be questioned influenza A/H1N1 at the next meeting of the Committee on Social Affairs to be held on the evolution of the pandemic, the President announced the National Assembly.

While the Socialist Party and the New Center called for a parliamentary inquiry committee on the subject, Bernard Accoyer said in a statement that the Social Affairs Committee has already heard the Minister on this issue three times in September, November and December last.

Roselyne Bachelot said on Tuesday it was ready to accept the principle of a commission and has called for the provision of Deputies to answer their questions.

The president of the National Assembly noted that the next meeting of the Committee on Social Affairs on the flu "will be extended to all members and open to the press. Other similar meetings will be organized.

Source: http://fr.news.yahoo.com/3/20100106/tpl-grippe-a-h1n1-vaccination-bachelot-a-cfb2994.html

European Parliament to Investigate WHO's Role in The Swine Flu Scare

Health threat from counterfeit pandemic - is the motto of the Council of Europe in January dealing with the influence of the pharmaceutical industry to the global campaign against avian and swine influenza. It provides for an emergency debate in the Parliamentary Assembly and a committee of inquiry.

It was initiated both by the former German Bundestag Wolfgang Wodarg (SPD), in the Parliamentary Assembly of the Council of Europe still in office as head of the subcommittee on health. Wodarg is a physician and epidemiologist, he considers the handling of the swine flu to be "one of the biggest medical scandals of the century".

In his committee unanimously adopted a resolution criticizing the influence of scientists and pharmaceutical authorities by enterprising entrepreneurs. This had resulted in "millions of healthy people were unnecessarily exposed to the risk of poorly tested vaccines were" - for an infectious disease that "is considerably more harmless" than any flu outbreaks in previous years and "not even one tenth of this normal deaths" have caused.

Worse than the fact that the vaccine manufacturers would have earned with their scare tactics at the expense of taxpayers so magnificently Wodarg found that "you took it too personal injury in department. The effect vaccines hidden in the amplifiers have barely been tested, "said the SPD politician, the Tagesspiegel. And side effects to dangerous nerve palsies were recorded by still patchy.

Source: http://www.zeit.de/politik/2009-12/schweinegrippe-europa

This has been translated from German and is not a perfect translation.

Norweigan MP Demands Answers From WHO's Director, Dr. Chan

Parliamentary member Laila Daavoey of the Christian Democratic Party has asked Health Minister Anne Grete Stroem-Erichsen to take up this question when she meets the mighty Margaret Chan, Director General of the World Health Organization, this week.

"It is obvious that many of those who gave advice to WHO in connection with the swine flu had economic interests in the pharmaceutical industry. It is certainly timely that this issue is taken up with the Secretary General. We see now that the fears of swine flu were exaggerated, and Norway and other countries are holding large surplus stocks of medicine, " Daavoey told Nettavisen.

Norway is not the only country to be left with large, unused stocks of vaccine. France announced on Monday that it will cancel 50 million of the 94 million vaccine doses ordered for the country. In view of the fact that several countriesare taking such action, it may come to affect earnings at drug makers, said analysts, according swissinfo.ch.

The French government has made its decision after intense criticism from politicians and scientists. The opposition in the French Socialist Party has described the country's pandemic management as an "extravagant failure" and demanded an investigation under the auspices of the National Assembly.

Source: theflucase.com, 8 January 2010.

Lawsuit over Girl Stuck in the Eye During Vaccination

A girl taken to a West Side health clinic to be immunized in 2007 instead ended up with the needle in her left eye after the staff failed to properly restrain her, a federal lawsuit filed today alleges.

Tanisha Thurman filed the lawsuit on her daughter's behalf against Access Community Network, which operates the Westside Family Health Center, 3752 W. 16th St. She is seeking more than $500,000 in damages.

While not explaining exactly how the injury allegedly occurred, the syringe punctured the girl's eye while she was being immunized, leaving her with "pain, suffering, disability and visual impairment," the lawsuit says.

Dr. Janis Mendelsohn, an associate professor of pediatrics at the University of Chicago, wrote in an attached affidavit that the "failure of the...employees to follow the standard of care caused an injury to (the girl's) eye."

Source: Chicago Breaking News Center, by Steve Schmadeke, 11 January 2010.