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.

Japanese Citizens Suing Government after They Got Hep B from Shared Needle Vaccine Programme

Six hepatitis B patients in western Japan filed a lawsuit Wednesday seeking damages from the government, joining nearly 400 people engaged in legal battles blaming the government for its failure to warn of the risk posed by shared needle use in group vaccinations.

The lawsuit at the Hiroshima District Court was expected to be followed by filings later Wednesday by about 30 other people poised to bring similar cases to courts in Sapporo, Tokyo, Niigata, Kanazawa, Osaka and Fukuoka.

In June 2006, the Supreme Court held the government accountable for neglecting the issue of the repeated use of syringes and awarded damages to five patients.

But a series of lawsuits have been filed with 10 district courts since March 2008 as the plaintiffs launched renewed efforts for damages from the government, claiming no progress has been made in providing relief for a majority of patients.

Earlier this month, one of the 10 courts — the Sapporo District Court — urged plaintiffs and the central government to reach a compromise settlement.

Source: The Japan Times, 25 March 2010.

Court Win! Court Determines Evelyn Sucher's Epilepsy was Caused by DTaP Vaccination

Based on the foregoing, both the vaccination and Evelyn’s genetic predisposition each
constitute a cause in fact of her injury, because the injury would not have occurred as it did but for each of these. The remaining question–the ultimate issue presented in this case–is whether the vaccination should be adjudged a substantial cause, or whether genetic predisposition constitutes a superseding cause under the law.

Respondent’s argument concerning genetic predisposition as a superseding cause centers
around an argument that the injury would have occurred sooner or later notwithstanding the vaccine: that it was overwhelmingly the genetic factor that caused the injury, and the vaccine only determined when such injury occurred. However, applying the same logic, one could argue in any case where the injury complained of is death, that death would have occurred eventually, even if it only occurred when it did because of the conduct or occurrence complained of. Death is certainly inevitable for mortal Man.

In sum, the Court concludes as a matter of law that, weighing Evelyn’s DTaP vaccination of
11 February as a causal factor, it was a substantial factor in bringing about her injury, and was not superseded by her genetic predisposition, which was also a substantial factor. Hence, the Court RULES that Petitioners are entitled to compensation.'

For the full court document, see:

http://www.uscfc.uscourts.gov/sites/default/files/ABELL.SUCHER031510.pdf

Vaccine Makers Targetted in Lawsuit

On April 1, 1992, Hannah Bruesewitz was a healthy infant. She had reached all of her developmental milestones for a 6-month-old, and that morning went to get her third round of the diphtheria, tetanus and pertussis vaccine.

That afternoon, as Hannah sat in her seat watching her mom fix lunch, the little girl startled, and her entire body stiffened.

"I didn't realize it was a seizure at first," said Robalee Bruesewitz, of Mt. Lebanon. "Her arms would shoot out, and she would look through me."

During one episode late in the afternoon, her mother knew something was terribly wrong.

"Within minutes, she let out this horrific scream. She stiffened and turned blue."

Hannah was rushed to the hospital, but doctors couldn't help her.

"The seizures continued and continued and continued," Mrs. Bruesewitz said. "Nothing could stop them for an entire week."

Over 16 days, the previously healthy infant had 125 seizures.

Instead of getting better, Hannah progressively worsened, to the point where -- now at age 18 -- she is completely non-verbal and needs 24-hour care.

After years spent unsuccessfully fighting in a federal administrative court to recover compensation for what they believe are vaccine-related injuries, the Bruesewitz family turned to the civil court system.

They filed a lawsuit against Wyeth Inc., the DTP manufacturer responsible for Hannah's injection, but the suit was thrown out in federal court.

Last year, the 3rd U.S. Circuit Court of Appeals upheld the lower court's decision. But in March, the U.S. Supreme Court agreed to hear the case.

It will be argued Tuesday.

At the center of the debate is whether the National Childhood Vaccine Injury Act of 1986 -- created to help shield vaccine makers from costly lawsuits, while at the same time providing compensation to children who suffered severe side effects from vaccines -- precludes civil litigation against vaccine manufacturers.

Under the act, a manufacturer cannot be held liable for design defects "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Wyeth argues that the passage clearly absolves them from civil liability.

But the Bruesewitz family argues that the preclusion turns on the word "unavoidable," in the act.

"The reality is, they had a safer vaccine at the time, and they withheld it from the market, said Russell Bruesewitz, Hannah's father.

The family claims in its Supreme Court brief that Tri-Immunol -- the vaccine Hannah received -- "had long been superseded by a more modern design, but Wyeth declined to change its DTP vaccine's design because it viewed the economic costs as outweighing any potential gain in market share."

"Hannah's vaccine was known to cause seizures," Ms. Bruesewitz said.

According to the family's Supreme Court brief, the lot number associated with Hannah's vaccine had an unusually high number of severe side effects, including two deaths and 60 adverse events.

Tri-Immunol, which first hit the market in the 1940s, was ultimately pulled by Wyeth in 1998.

But the vaccine maker argues in its Supreme Court brief that, contrary to the Bruesewitzes' claims, the company could not have sold a safer alternative because one was not approved by the U.S. Food and Drug Administration for children under the age of 2 until 1996.

A large part of the frustration experienced by the Bruesewitzes is their perceived failure of the National Vaccine Injury Compensation Program.

Designed, they thought, to specifically help families like theirs, the program, instead, led them on an 8-year roller coaster, eventually ending in disappointment.

The Bruesewitz family filed their claim with the program in April 1995.

Up until a month before their claim was filed, residual seizure disorder -- what Hannah has -- was a covered injury. All the family had to do is show that Hannah had the disorder, and under a table of listed vaccine-related injuries, it would be presumed that the DTP vaccine caused it, and they would be compensated. The vaccine compensation program is funded by an excise tax put on every vaccine.

But in March 1995, the U.S. Department of Health and Human Services removed residual seizure disorder from the list of compensable claims for the DTP vaccine.

Because it was removed, the Bruesewitzes were told they would have to prove that the vaccine caused Hannah's injuries.

Despite eight years of trying, they failed to prove causation, and their claim was refused.

"It was contrary to the whole concept -- to make it expeditious and generous," Mr. Bruesewitz said.

In fact, a study by the U.S. General Accountability Office in 1999 showed that there was debate whether the vaccine program was serving its purpose of providing compensation "quickly, easily, with certainty and generosity."

The study showed that the department of Health and Human Services had removed more compensable injuries from the table than had been added -- despite an increase in the number of childhood vaccinations -- and that there was no clear and transparent methodology being used to do so.

Further, it was often taking years to process the claims. In February 1999, 57 percent of cases had taken more than two years, and 18 percent of those had taken longer than five years.

According to a September 2010 statistics report from the U.S. Health Resources and Services Administration, since fiscal year 1999, a total of 2,503 vaccine claims were awarded $1.9 billion. That averages out to more than $774,000 per claim.

However, another 2,293 claims have been dismissed.

And a report from August shows that since the Vaccine Court program began, there have been vastly more claims filed related to the DTP vaccine than for any other, with a total of 3,978. Of those, 696 claims were for the death of a child.

Out of all DTP claims, only 1,265 received compensation, while the majority were dismissed.

Before residual seizure disorder caused by DTP was removed from the list of compensable injuries, 1,713 claims were filed listing that problem. Of those, 654 received compensation totaling $480.9 million, according to the Health Resources and Services Administration.

It is the federal government that controls what injuries are covered and what claims receive awards. According to the Department of Health and Human Services, residual seizure disorder was removed from the list of covered injuries because reviews by the Institute of Medicine concluded that there was no evidence showing a causal relationship between pertussis vaccine and seizures.

Vaccine manufacturers were not involved in that process.

Curtis L. Allen, a spokesman for Pfizer Inc., now the parent company of Wyeth, said it is their hope that the Supreme Court upholds what they believe was the intent of Congress -- to have issues about the proper design of vaccines be decided by FDA and CDC experts, not state court juries.

"While we have great sympathy for the Bruesewitz family and understand how conditions of the type Hannah Bruesewitz suffers from can take an extraordinary emotional and physical toll on a family, it is important to recognize that her claims received full consideration in Vaccine Court, and that court determined that her condition was not caused by vaccination," Mr. Allen said.

Wyeth and its supporters argue that if the Bruesewitzes succeed in their claim, the potential for large payouts in civil litigation will drive the few remaining vaccine makers from the market.

Much of the driving force behind the 1986 legislation was that manufacturers were facing increased civil lawsuits and large awards.

They were being driven from the market, said Dr. Marion Burton, the president of the American Academy of Pediatrics, which has filed a brief in support of Wyeth.

"We had a potential crisis in getting the seven vaccines recommended for children," Dr. Burton said.

With the passing of the 1986 vaccine act, he continued, the vaccine market stabilized. The protection from litigation provided by the act has even allowed drug manufacturers to develop an additional eight vaccines now recommended for children.

"This is the most effective public health program of this century," Dr. Burton said. "You have to take the manufacturers out of the line of fire, unless they've done something profoundly negligent."

If the Supreme Court finds in favor of the Bruesewitz family, Dr. Burton fears it could bring a cascade of lawsuits against the manufacturers.

"We're going to be back in the same dilemma," he said.

But the Bruesewitzes, who are not opposed to vaccinations in general, don't think that's the case.

"We want the government to hold the manufacturers of these vaccines accountable," Mr. Bruesewitz said. "They're totally immune. We do need to know they're making safe vaccines and being held responsible.

"There's an altruistic part of it, too. We can carry the burden for others in similar situations."

Source: Pittsburgh Post-Gazette, by Paula Reed Ward, 11th October 2010.

Jared Wright, 11, Wins First Round in Vaccine Court after SIX mercury Containing Vaccines Made Him Autistic

Less than a week after another scathing report dismissing the theory that vaccines and autism are linked made international headlines, an en banc state Superior Court panel remanded the products liability case of an 11-year-old autistic boy, directing a Philadelphia trial court to determine whether the design defect claim arose from unavoidable vaccine side effects.

The boy's parents and attorney argue that mercury contained in the vaccines -- manufactured by the pharmaceutical company defendants -- caused their son's autism.

If the trial court ultimately finds that the side effects were unavoidable, the claim will be pre-empted by a federal law governing the liability of pharmaceutical companies for drug vaccines.

If the side effects are found to have been avoidable, however, the claim could proceed.

Whether it would ultimately succeed is less clear.

Asked whether he felt the theory behind his case had been hampered by lack of support from the scientific community, the plaintiff's attorney, Marc P. Weingarten of the Locks Law Firm in Philadelphia, simply said it was a question that would need to be answered at trial.

"That's the main issue on the merits of the case and something we have to still get in front of a judge and jury," he said, adding that the Superior Court's ruling Tuesday had little to do with the merits of the case.

The panel ruled 8-1 in Wright v. Aventis Pasteur to reverse Philadelphia Common Pleas Judge Arnold L. New's ruling granting summary judgment in favor of pharmaceutical defendants Aventis Pasteur Inc., Merck & Co. Inc. and Wyeth with regard to the design defect claim.

Judge New had found that the plaintiff's design defect and failure-to-warn claims were expressly pre-empted by the federal National Childhood Vaccine Injury Act.

While Superior Court did unanimously affirm Judge New's ruling with regard to the failure-to-warn claim, it said Congress did not intend for all vaccination design defect claims to be pre-empted by federal law.

Judge Sallie Updyke Mundy said in a 72-page opinion for the majority that Section 300aa-22(b)(1) of the Vaccine Act "expressly pre-empts all design defect claims that arise from unavoidable vaccine side effects, and before granting summary judgment, the trial court was required to conduct a case-by-case inquiry to determine the nature of the vaccine side effects presented in this case."

Judge Mundy was joined in the majority by President Judge Correale F. Stevens and Judges Kate Ford Elliott, Jack A. Panella, Christine L. Donohue, Cheryl Lynn Allen and Anne E. Lazarus.

Judge Susan Peikes Gantman concurred in the result.

Judge Jacqueline O. Shogan, however, said in her concurring and dissenting opinion that "the statutory language, FDA functions, federal case law and legislative intent support the trial court's conclusions that the Vaccine Act pre-empts the design defect claim and that vaccine defendants were entitled to the presumption of proper warning."

In Wright, Jared Wright, 11, of Texas, was administered five vaccines in the first 18 months of his life that contained thimerosal, a mercury-based preservative once used in vaccines to deter bacterial growth, as well as one other vaccine, according to Judge Mundy. Jared's parents, Howard and Jacqueline Wright, claimed that the mercury in those six vaccines caused their son's autism.

Judge New wrote in his own 2008 opinion that Congress "clearly intended" the Vaccine Act to pre-empt all state design defect claims without a case-by-case assessment of whether the vaccines' side effects were unavoidable because Congress didn't want instability in the vaccine market to be caused by numerous torts over vaccine injuries.

Judge New also noted that other courts' decisions -- including the U.S. District Court for the Eastern District of Pennsylvania's 2007 ruling in Bruesewitz v. Wyeth, which was argued before the U.S. Supreme Court in October 2010 -- have been similar.

But according to Judge Mundy, while Bruesewitz found that the Vaccine Act is structured in such a way that Section 300aa-22(b)(1) stands as "an outright bar to [at least] some claims," the Superior Court found it could be interpreted the opposite way as well.

Judge Mundy said Subsection 22(e) of the Vaccine Act prevents any state from making a law prohibiting individuals from bringing civil suits against a vaccine manufacturer for a vaccine-related injury or death as long as the Vaccine Act does not pre-empt such a suit. According to Judge Mundy, this implies that the Vaccine Act pre-empts some state tort claims, but also expressly preserves others.

Source: Post-Gazette.com, 17th January 2011.

Controversy Over Illegal Vaccine Trials

PARTICIPANTS in controversial vaccine trials in mother-and-baby homes have been told by the Department of Health that it can’t give them their medical files or any trial documentation as it is legally bound to return the files to the drugs company.


The files are in the hands of the Laffoy Commission on Child Abuse, which was forced to halt its vaccine trials investigation following a 2002 court case.

Last night, Brenda McVeigh of the commission confirmed that they were "undertaking an examination of all documentation that they have and cataloguing it". She said no files have yet been returned to Glaxo SmithKline.

A letter from the Department of Health to the Oireachtas Joint Committee on Health and Children, seen by the Irish Examiner, states that the department cannot hand over the documentation to the committee or to participants as legally "it is not possible for that material to be used for any other purpose" other than Laffoy Commission investigations.

"In the circumstances, I understand from the commission that they will be returning all documentation to the source that originally provided it", the letter read.

The vaccine trials will be discussed by the Joint Committee in private tomorrow.

One of its members, Labour’s Kathleen Lynch, last night said the files have to be handed to the people used in the trials, irrespective of recent court rulings.

"I firmly believe the files must be given to victims as a human right. But until they are handed over and until this is finalised, they must be protected and must not be destroyed by any body or any company," she said.

Up to 211 children were given the test vaccines in Ireland in the 1960s and 1970s. Now adults, the participants say the drugs were given without parental consent and they have spent years trying to access their medical files and pharmaceutical information from that time.

They are also seeking previously unseen files obtained by the Laffoy Commission from medical companies.

The Laffoy Commission was investigating vaccine trials between 1940 and 1987 as part of a separate module. However, the commission’s investigation was brought to a sudden halt after court action taken by the doctors involved in the trials.

Last September, after it emerged that a woman now living in the US was seeking to sue the Sacred Heart Order and Glaxo SmithKline about the administration of the vaccines, the Oireachtas Joint Committee on Health and Children decided to revisit the vaccine trials issue.

The committee wrote to Glaxo SmithKline seeking information on the trials. The company said the documentation contained sensitive personal information and they wouldn’t hand it over without judicial order.

Source: The Irish Examiner, 24th January 2011.

Vaccine Company Liability Lawsuit Lost But Two Lawyers Dissent

The Bruesewitz family lost their case after they tried to sue a vaccine company after their daughter became disabled and developed a seizure disorder after her 6 month shots.

If they had won, vaccine companies would have been responsible for injuries and deaths that they cause and would have been required to manufacturer safe or safer products.

Judges ruled that vaccines were inherantly unsafe and therefore it was not possible to avoid such an injury scenario.

However, two lawyers dissented from that view, saying that manufacturers should be responsible for their products.

Dissenting view begins on page 30:

http://www.supremecourt.gov/opinions/10pdf/09-152.pdf

Jerry Joseph Tufo Jr vs. Secretary of Health and Human Services

Jerry was born on March 30, 1981. He received his first MMR on September 20, 1982. He
received his second MMR on January 24, 1995, when he was almost fourteen years old. Eighteen
days later, on February 11, 1995, he was unable to move his legs. He was evaluated at Eglin Air
Force Base Hospital Emergency Room and then transferred to Sacred Heart Hospital that same day
with a history of not having had a bowel movement for five to six days, and having had mild coldlike
symptoms all week. Med. recs. at Ex. 8, 10.
Jerry was at Sacred Heart Hospital from February 11 to March 2, 1995. He improved slowly
and had temperature spikes of 103°. On physical examination, there was no obvious source of
infection. His chest x-ray was clear. On February 28, 1996, a thoracic spine MRI showed markedly
abnormal appearance with mild to moderate atrophic changes from T-2 to T-6 and severe atrophy
from T-6 to T-12. Med. recs. at Ex. 16, p. 1.

When asked about Jerry’s cold-like symptoms that had lasted a week, Dr. Renfroe replied
their onset was 10 days after Jerry’s MMR and occurred at the same time as his bowel complaints.
Tr. at 21. He thinks these were sequelae of a reaction to MMR. Id. Dr. Renfroe diagnosed Jerry as
having GBS. Tr. at 10-11. When he initially saw Jerry, Jerry became rapidly weaker and, when his
respiratory system became compromised, he needed to be intubated. Tr. at 10. Jerry had rapidly
ascending neuropathy, which is classic for GBS, and areflexia. Tr. at 11. The staff discussed
whether or not he had TM. Id. His MRI showed central lesions but Jerry’s lesions were higher than
the lesions associated with TM. Id. He had cranial paralysis. Id. Dr. Renfroe does not disagree
with the diagnosis of GBS. Tr. at 12.
Jerry’s paralysis progressed to his arms. Tr. at 14. He could not speak. Id. He rapidly
deteriorated over one to two days. Tr. at 15. His paralysis was asymmetric, rather than complete.
Id. He had facial diplegia and could only blink. Id. The neuroconduction technician said Jerry had
GBS because he did not have F waves. Tr. at 16.
Jerry responded to intravenous immunoglobulin, which blocks antibodies and speeds
recovery. Tr. at 17. He made a rapid turn around. Tr. at 18. His residuum is severe impairment
below the waist, both sensorily and motorically. Tr. at 19. He is blocked below approximately the
T-10 level because of a spinal lesion rather than GBS. Id.
Dr. Renfroe had two theories to explain causation from MMR: (1) the autoimmune
phenomenon, or (2) immunosuppression. Tr. at 23-24. With the autoimmune theory, 10 to 12 days
after receiving MMR, Jerry had autoimmune myeloradiculoneuropathy but, at the beginning of his
17 Petitioners did not submit the Joyce article into evidence.
11
hospitalization, the doctors did not know of his back involvement. Tr. at 23. That did not affect
their treatment of Jerry. Id. With the immunosuppression theory, MMR vaccine gave Jerry a
transient viral syndrome. Tr. at 24. A percentage of patients are immunosuppressed after MMR.
Id. When challenged with an unknown virus, they develop TM. Id. His TM may have caused his
GBS because he had antibodies to both the central and peripheral nervous systems. Tr. at 24-25.

The Joyce article in The British Medical Journal describes a case of TM after MMR
vaccine.17 Tr. at 32-33. There is other medical literature describing GBS after measles virus
infection. Tr. at 33.
GBS is a postinfectious, autoimmune disease. Tr. at 38. TM may be autoimmune or directly
infectious. Id. Much later, after Jerry’s lower extremities failed to recover, he had an MRI which
discovered that he has TM. Tr. at 39. Dr. Renfroe opined that MMR was the cause. Tr. at 39-40.
His basis is that Jerry’s clinical course creates a plausible and probable association that he had an
immunosuppressive or autoimmune response based on Dr. Renfroe’s clinical experience, his
knowing Jerry, and the medical literature. Tr. at 40.

There is a temporal relationship to these challenges to Jerry’s immunological defenses. Tr.
at 50. It takes over a week to have immune suppression after MMR. Tr. at 51. An opportunistic
virus could have appeared 10 days post-MMR. Id.
On cross-examination, Dr. Renfroe stated that Jerry’s mild cold-like symptoms could not
have caused his GBS because they were simultaneous with the GBS’s onset. Tr. at 55-56. But, the
upper respiratory syndrome could have been a viral syndrome, which is a frequent reaction 10 days
after an MMR inoculation. Tr. at 56.
Jerry had an elevated protein in his cerebrospinal fluid above 300 (the normal range is zero
to 50). Tr. at 58. His white cells were 62, consistent with an ongoing infection and inflammatory
process. Tr. at 59-60. He thinks that the MMR caused both a viral infection whose onset was
February 3, 1995, and Jerry’s GBS and TM whose onset was February 10, 1995. Tr. at 63- 66.
MMR is a live, attenuated virus vaccine. Tr. at 73. Viruses are strongly associated with GBS. Id.
Jerry’s GBS began 17 days after vaccination, on February 10, 1995. Tr. at 103–4.

In his clinical experience, if GBS follows MMR by two weeks and there is no other known
antecedent, it is biologically plausible, temporally-related, and supported by the medical literature that the vaccine caused it. Tr. at 145-46.

Petitioners have satisfied their burden of showing a logical sequence of cause and effect
between MMR vaccine and Jerry’s ADEM based on: (1) the testimony of Dr. Renfroe, Jerry’s
treating pediatric neurologist, (2) the medical literature which supports that vaccinations are a known
cause of ADEM; (3) the understanding of immune-mediated disease, particularly those manifesting
hypersensitivity to MBP; (4) the time sequence here which was appropriate for an immune-mediated
response; and (5) the simultaneous occurrence of cold-like symptoms and bowel dysfunction, which
means that the former could not have caused the latter due to the lack of time for an immunemediated
response to occur.
CONCLUSION
Petitioners are entitled to reasonable compensation. The undersigned hopes that the parties
may reach an amicable settlement, and will convene a telephonic status conference soon to discuss
the filing of life care plans, unless the parties agree on a joint life care plan.

For the full court document, see:

http://www.uscfc.uscourts.gov/sites/default/files/Tufo.pdf

Parents of baby girl who was a victim of flu vaccine debacle suing State Government

THE parents of a baby girl who was a victim of last year's flu vaccine debacle are suing the State Government in a potential multimillion-dollar damages claim.
Mick and Kirsten Button's daughter, Saba, suffered global brain injury plus kidney, liver and bone marrow failure after prolonged seizures following her vaccination shot. She may never walk or talk.

Legal experts believe a payout of more than $10 million is not out of the question. The Sunday Times understands a writ will be served in the District Court this month.

The Buttons have engaged medical litigation specialist Julian Johnson, and any compensation would help pay for what happened to Saba as well as provide access to the best available treatment and care for the future.

While the family declined to talk about any legal action, they have opened up on how isolated they have felt since Saba was given the CSL Fluvax shot on April 19 last year.

It was only last month that the head of immunology and research at Princess Margaret Hospital met Mrs Button even though she has made numerous requests to see him about what happened to Saba.

He also recently conceded: "If we had reacted sooner, then a number of children getting sick wouldn't have happened and that would have included Saba and that's something we will have to live with.''

Health Minister Kim Hames has not been in touch with the family despite admitting April 22, 2010 (the day he suspended the seasonal flu vaccine program) was "one of the darkest days I have had as Health Minister''.

Mr Hames said: "To be told our childhood influenza vaccination program might be putting Western Australian children at serious risk was nothing short of devastating.

"I remember being told a series of presentations of children with febrile convulsions had presented to PMH and at least one was in the hospital's intensive care unit. We suspended the program within hours, a full day before the Commonwealth followed suit and suspended the program nationally.''

Dr Hames said he believed the Buttons did not want to meet him or anyone from the Health Department.

"I am willing to meet the family should they express a desire to do so,'' he said. "Our advice has been the family wished to maintain their privacy as they dealt with the ongoing care of their daughter. I will continue to respect that request.''

But the Button family deny this.

"At the time in ICU we were asked if we wanted the media involved and we said a definite 'no','' Mrs Button said. "But we never said anything to anyone else.

"Definitely, no one from the Department of Health or Kim Hames' office has come to see us or introduce themselves.''

Mr Button said: ``We haven't had any feedback from the Health Department or the Minister.''

Before Saba had her shot there had been more than 100 "adverse reaction'' presentations at PMH as well as dozens of troubling reports around the state. But this information wasn't passed on to the general public until after Saba was in the intensive-care unit.

An independant inquiry found "serious deficiency'' in reporting processes and slow responses by both state and federal authorities.

It also concluded the Department of Health's Communicable Disease Control Directorate was "informed of a significant rise in adverse reactions in early April 2010, but did not take any further action while they gathered data''.

Saba has been back to PMH 11 times and still suffers seizures and respiratory problems. The CSL Fluvax product is not available for children under five this year.

In 2008 compensation believed to be $6 million was awarded to a Perth family whose 10-month-old son was left blind, deaf and brain-damaged after a misdiagnosis.

Nicola and Peter Netherway sued St John of God Hospital and a doctor after their son, Jeremy, was treated for a virus when he had the potentially fatal bacterial infection pneumococcal meningitis.

One of the largest medical negligence payouts in Australia occurred in 2001 when the NSW Supreme Court awarded Calandre Simpson $14 million dollars (reduced on appeal to $11million) after a botched forcep delivery left her with cerebral palsy.

Dr Hames said "he did not intend to discuss matters relating to compensation in public''.

Source: http://www.perthnow.com.au/news/western-australia/parents-launch-flu-shot-damages-claim/story-e6frg153-1226032663603

First Lawsuits Against HPV Vaccine

Their mothers thought they were doing the right thing: protecting their daughters against a disease -- cervical cancer – that had been so gravely depicted on television and radio commercials, and was even the subject of a feature film.

But now, Gardasil, the vaccine the two teenagers took after it was put on the market in France back in November of 2006, has transformed their lives into a nightmare, say Laura Agnès, 16, and Laëtitia Celli, 20.

The two young French women recount how their days are interrupted by unpredictable paralysis, headaches and unbearable stomach aches that they say began after the vaccination that was distributed throughout France by Sanofi Pasteur MSD laboratory.

Last week, they sent a claim for indemnification to the Commission of Conciliation and Compensation for Medical Accidents (RCCI) in Lyon. Their lawyer describes the complaint: “The first problems occurred after their injections, and these young girls were in good health before, and there is no previous case of problems in their family.”

A vaccine “released blindly”?

Agnès, who lives in Rives, in eastern France, had dreams of being a nurse. “Doctors have advised against the vaccine. However, for this profession, some are obligatory,” her mother, Stephanie Agnès, explains. Influenced by the television spots, she decided to have her daughter vaccinated in 2009, when she was 14 years old. “She had not asked for it. I poisoned her. The numbers shocked me. On the news, they were showing women who were victims of this cancer. I told myself that they could not have released this vaccine blindly.”

The first medical problems arose several weeks after the first injection: tingling, followed by paralysis in the left leg. It took Laura three months to recover normal use of her leg. At the second injection, when the elbow is touched, the neurologist believed it was a genetic disease, but he found nothing. Results of blood analysis were also good. “During this time, my daughter was going to school as much as she could,” her mother says. Laura had to repeat her eighth grade

For Laëtitia Celli, from Digne-les-Bains in southern France, it was also her mother who pushed her to get the vaccine. “Even though she didn’t want it,” says Rachel Celli, wife of a police officer. “But they scared the hell out of me with their messages.” The side effects arose the evening of the first injection: fever, nausea, and dizziness. At the second injection, Laëtitia, then in the 11th grade, describes “a stabbing in her stomach. It was unbearable. The dizziness and the vomiting would come suddenly every two or three days. I had to stop going to class.”

Celli describes a life transformed. “I was energetic, I did sports, I saw my friends, and, from one day to the next, it became hell [for me]. I could no longer even go to the movies, since the light bothered me. At 20 years, I still had other things to do, right?”

Establishing a connection

In response, Sanofi Pasteur sent them to the French Agency for the Safety of Medical Products, which has received 1,700 claims for Gardasil that, like any new medicine registered at the European level, was the subject of a risk assessment plan. These claims concern “essentially the fever during the days just after the injection,” says Bernard Delorme, the person responsible for patient and public information.

Some cases of autoimmune diseases were found, “but not more than for other vaccines,” he adds. “The proportion of undesirable, serious side effects is the same as those that naturally occur in this segment of the population.” In order for these young girls to be compensated, the experts at the Chamber of Commerce and Industry have to establish a link between the vaccine and the symptoms. But as of yet, no doctor has formally discovered this connection.

In Laura Agnès’s case, the hospital at Voiron mentions, nevertheless, a “chronic polyradiculoneuropathic condition, probably due to the Gardasil injection.” Another medical center in Grenoble, after having observed the “chronology of appearance” of the side effects, judged that, “to be prudent, due to the cost/benefit relationship, the third injection of Gardasil [should be skipped].”

As for Celli, she has latched onto statements from the Chamber of Commerce and Industry: “Finally someone has started to believe me, and find a solution to my pain.”

Source: World Crunch, by Emeline Cazi, originally published in French in Le Monde newspaper.

Man Loses Vaccine Damage Case After Measles Jab Damages His Brain

A MAN who claimed he suffered from hyperactivity and mental retardation because of a measles vaccine he received as a baby has lost a High Court action for damages against the State and a doctor.

Alan O'Leary (24) brought proceedings against the HSE, the State, the attorney general and a GP, claiming there was a disregard for the vaccine manufacturer's recommendation that it should not be administered to those such as himself with a family history of epilepsy. He was given the vaccine in 1988.

Mr Justice John Quirke said yesterday he was satisfied no evidence whatever had been adduced which the court could possibly infer any negligence on the part of the State or any breach of its duty of care to Mr O'Leary of Ballyphehane, Cork.

The judge dismissed the proceedings after the defendants argued the evidence fell short of establishing a prima facie (on the face of it) case against them.

The defendants had denied the claims.


unsafe

Mr Justice Quirke also dismissed Mr O'Leary's action against the GP who administered the vaccine to the plaintiff when he knew or ought to have known it was unsafe and dangerous to do so.

The judge said the only evidence suggesting negligence on the part of the GP was from a UK-based consultant neurologist.

Professor Leslie J Findley gave evidence the GP ought to have made a note recording an appropriate warning dealing with the remote risk of brain damage associated with the vaccine, the judge said.

Dealing with the case against the State, the judge ruled no representation, warranty or promise was made by the State to the plaintiff which could give rise to a legitimate expectation that the plaintiff would be compensated if he suffered an injury from participation in the measles vaccine programme.

It had been contended, the judge said, that the plaintiff's right to bodily integrity had been violated and the State was obliged to vindicate that right by providing him with compensation.

"I do not believe that contention can be correct."

The judge dismissed the claim against all defendants

Source: http://www.herald.ie/national-news/courts/man-loses-his-measles-jab-damage-case-2826467.html

Gardasil Victims Take Legal Action Against Merck Over Miscarriage, Deadly Reactions

When one Australian woman decided to lead the charge against Gardasil maker Merck after experiencing serious adverse reactions, she soon found another 7 Victorian women with similar intentions and experiences. Naomi Snell, a resident of Melbourne, Australia, suffered an auto-immune and neurological attack after being injected with the HPV shot Gardasil. After reading about a Sydney neurologist who exposed Gardasil as a potential cause of MS-like symptoms, Snell realized that Gardasil could be behind her recent health ailments.

She made a timeline of her declining health using reports from her doctor and physiotherapist. What she found was that the events unfolded right after she had received the Gardasil vaccine. At 28 years of age, Snell lost her ability to walk, suffered from crippling back and neck pain, and experienced convulsions that put her life on hold for 2 years. The health issues started soon after receiving the HPV shot in July 2008.

Source: http://republicbroadcasting.org/?p=17925

Argentina fines drug company over vaccine trial

A medical group in Argentina is asking for more drug-testing regulations in the South American country after a officials fined pharmaceutical company GlaxoSmithKline for alleged irregularities in a pediatric pneumonia vaccine trial.

The Argentinian Federation of Health Professionals accuses drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis.

"They recruited children in an irregular manner. ... They did not do what they were supposed to. They did not inform. There were not independent witnesses. They pressured the mothers of poor children," said Jorge Yabkowsky, the federation's director.

But GlaxoSmithKline, the world's second largest pharmaceutical company, denies those accusations and says it will appeal a judge's approval of Argentina's National Administration of Medicine, Food and Medical Technology's fining the company and two doctors a total of nearly $240,000 for irregularities in documentation of the trial.

In a statement, GlaxoSmithKline said it conducts clinical studies all over the world, respecting laws and meeting the highest standards of ethics and quality.

"The ruling has to do with procedures, with the form of documenting procedures of the studies. ... None of the patients that were included in this study were included without their appropriate consent," said Rosana Felice, medical director of Glaxo Argentina.

Felice said official investigations by Argentina's drug administration, known as ANMAT, and ethics reviews have not turned up any irregularities in the vaccine's safety.

GlaxoSmithKline's statement said there are no cases alleging fraud or corruption in the study.

The deaths of 14 children who reportedly died after participating in the trials, have drawn widespread attention in Argentinian media. Their deaths are under investigation, but there has been no evidence linking deaths to the vaccine or irregularities in the studies.

Felice said GlaxoSmithKline categorically denies that the vaccine caused the deaths.

"In no case was it related to the administration of the vaccine, and this has been sufficiently demonstrated, proven and evaluated by ANMAT," Felice said.

But the health professional federation pointed to the children's deaths in its call for increased regulations on drug testing.

The trial included 24,000 children, Felice said, including 14,000 children in Argentina and 10,000 others in Colombia and Panama.

The Synflorix vaccine has been approved by regulatory agencies in more than 85 countries, based on more than 40 clinical studies, GlaxoSmithKline said.

Source: CNN, 4th January 2012. http://edition.cnn.com/2012/01/03/world/americas/argentina-drug-company-fined/index.html

Family sues after teen dies following HPV vaccination

The family of a Quebec teen who died after taking a common vaccine is suing pharmaceutical giant Merck Frosst, three doctors and a clinic for $197,000.

Annabelle Morin's body was found in a bathtub in her family's suburban Laval home on Dec. 9, 2008. The lawsuit says she had taken two doses of the human papillomavirus (HPV) vaccine — used to prevent cervical cancer in women.

Linda Morin found her daughter in the tub.

"This image will stay in my head for the rest of my life," Morin told QMI Agency. "It's a nightmare. We often say that time heals things (but) time hasn't healed anything yet."

Annabelle, 14, was among an initial group of youngsters who received a free Gardasil vaccination under a program introduced by Quebec in September 2008.

She received a first dose at a clinic in October 2008 and her mother said she vomited, became confused and incoherent and was unable to speak or walk.

She went to hospital, was diagnosed with a migraine and was discharged.

Annabelle received a second dose of Gardasil at her school on Nov. 24, 2008, and fell ill a second time, the lawsuit says.

Two weeks later she was found unconscious in the bathtub. She was pronounced dead in hospital.

The lawsuit says pediatrician Guylaine Larose, neurologist Amelie Nadeau and Annabelle's family doctor, Lynne Nadeau, were negligent in their treatment.

Linda Morin says she was never advised that Gardasil can have side-effects.

A coroner could not establish a direct link between the vaccination and Annabelle's death.

Source: Toronto Sun, 31 January 2012.

Major Drug Maker Accused of Killing 14 Vaccine Trial Subjects

A medical group in Argentina is asking for more drug-testing regulations in the South American country after a officials fined pharmaceutical company GlaxoSmithKline for alleged irregularities in a pediatric pneumonia vaccine trial.

The Argentinian Federation of Health Professionals accuses drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis.

"They recruited children in an irregular manner. ... They did not do what they were supposed to. They did not inform. There were not independent witnesses. They pressured the mothers of poor children," said Jorge Yabkowsky, the federation's director.

But GlaxoSmithKline, the world's second largest pharmaceutical company, denies those accusations and says it will appeal a judge's approval of Argentina's National Administration of Medicine, Food and Medical Technology's fining the company and two doctors a total of nearly $240,000 for irregularities in documentation of the trial.

The deaths of 14 children who reportedly died after participating in the trials, have drawn widespread attention in Argentinian media. Their deaths are under investigation, but there has been no evidence linking deaths to the vaccine or irregularities in the studies.

But the health professional federation pointed to the children's deaths in its call for increased regulations on drug testing.

The trial included 24,000 children, Felice said, including 14,000 children in Argentina and 10,000 others in Colombia and Panama.

Source: CNN, 4th January 2012.

SC moved against underhand import of measles vaccine

The Transparency International Pakistan (TIP) has prayed to the Supreme Court (SC) to restrain Prime Minister Yusuf Raza Gilani from allowing relaxation in rules to purchase 19 million doses of anti-measles vaccine worth Rs1 billion, otherwise the lives of millions of children could be endangered. It is learnt that the prime minister can sign the special orders any time within the next 48 hours.

Submitting an application in the SC Registrar Office on an emergency basis, the TIP said in 2007 dubious tenders for measles vaccine were floated which not only debarred 15 companies registered with World Health Organization (WHO), but no vaccine producing company in the entire world came up to the standard laid down by the advertiser. The tender was awarded to a company, which does not produce vaccines at all.

Likewise with the permission of Inter-Provincial Coordination Committee, the PPI Board wrote a letter to Premier Gilani that rules may be relaxed so that order may be issued to a particular company.

The TIP has further said that vaccine can be obtained on an emergency basis by inviting international tenders after standardizing the tender documents. This would enable the government to procure vaccine at cheaper rates, as the vaccine will be provided by the best internationally certified companies. The TIP has further prayed that no vaccine should be allowed to be used without ensuring its standard and also that the same is not expired.

Source: The International News, 2nd February 2012.