February 14, 2012
By Ethan A. Huff
“Even if you were home schooled and never given vaccines, once you go to college, you have to get vaccinated. No matter which way you turn, big pharma is there to stick it to you.”
Former presidential candidate and Texas Governor Rick Perry has signed into law new legislation that requires all college students, including those living off campus, to get injected with a meningitis vaccine. The new guidelines, which reportedly received bipartisan support, require that all students under the age of 30 show either proof of vaccination or a signed affidavit of exemption before being allowed to come to class.
Effective beginning spring semester 2012 for all students enrolled at both public and private colleges and universities across Texas, the mandate expands a previous one enacted in 2009 that requires only students living on campus to get the shot. And even though all students still have the freedom to decline the vaccination as a matter of conscience or for religious reasons, many of them are not being told this by their schools, and are just going along with it.
Though the entire state of Texas had only 34 reported cases of meningitis among young people between the ages of 15 and 29 in 2009, Gov. Perry, the Texas Medical Association (TMA), and several state senators expressed vehement support for the new bill, S.B. 1107, which further expands the government’s reach into the personal health choices of Texans.
October 21, 2011
By MARIA CHENG
Scientists are warning officials negotiating a global treaty on mercury that banning the deadly chemical completely would be dangerous for public health because of the chemical’s use in vaccines.
The ban option is one of several proposals on the table for a meeting later this month in Nairobi, but a final treaty isn’t expected until 2013.
According to the World Health Organization, mercury is one of the top 10 chemicals of public health concern and is highly toxic. Most of the worry is centered on mercury emissions from burning coal, gold mining and people eating mercury-tainted fish.
Mercury in small amounts is also found in many products including light bulbs, batteries and thermometers. WHO advises such products to be phased out, suggesting for example, that health systems switch to digital thermometers instead.
The problem is that a proposed ban might include thiomersal, a mercury compound used to prevent contamination and extend the shelf life of vaccines, many scientists say. It is used in about 300 million shots worldwide, against diseases including flu, tetanus, hepatitis B, diptheria and meningitis.
“Not being able to use mercury is not a viable option,” said David Wood, a WHO vaccines expert.
Wood said there isn’t a viable alternative to thiomersal at the moment. If banned, pharmaceuticals would likely have to switch to preservative-free vaccines, which would complicate the supply chain and vaccination campaigns in poor countries, since the injections would have a much shorter shelf life. Costs would also spike since manufacturers would need to reconfigure their factories.
In 2009, the United Nations Environment Programme, or UNEP, began working on a legally binding global treaty on mercury. At the end of October, the third of five meetings to hammer out a treaty will take place in Nairobi.
“The document is a draft at the moment, so some of these proposals have to be taken with a grain of salt,” said Tim Kasten, head of the chemicals branch at UNEP. Kasten said the amount of mercury in vaccines is so minute it doesn’t threaten the environment. He said there could be provisions to allow mercury for certain uses, such as in dental fillings and vaccines.
But according to an annex in the draft document, there is currently no “allowable use exemption” for mercury products in pharmaceutical products, putting vaccines in the same category as banned mercury-containing paints and pesticides.
“That would be a terrible idea,” said Paul Offit, an infectious diseases expert at the University of Pennsylvania. “It would be another tragic example of us not being able to explain to the public where the real risk lies.”
Thiomersal has mostly been removed from childhood vaccines in the U.S. and Canada. In some European countries, including Norway and Sweden, manufacturers have been encouraged to make thiomersal-free vaccines – and no other uses of mercury as a medical preservative are allowed.
Fears about thiomersal in vaccines were first raised after a flawed medical study in 1998 linked a common childhood injection to autism. But numerous studies since have found no sign the mercury compound is risky.
Experts hope countries won’t go overboard in their attempts to control the substance.
“Provided you know the risks and it’s handled properly, there isn’t a problem,” said Andrew Nelson, a toxicology expert at the University of Leeds. “The health of so many millions of children benefit from vaccines containing mercury that an absolute ban is ridiculous.”
August 12th, 2011
The Raw Story
By: Agence France Presse
US pharmaceutical giant Pfizer on Thursday began long-awaited compensation payments to families over a 1996 drug trial blamed for the deaths of 11 children and disabilities in dozens of others.
But even as the compensation process began, the company faced further criticism since only four families were paid in the initial disbursements, while some 200 children participated in the trial of meningitis drug Trovan.
Parents of four of the children who died received cheques of $175,000 each at a ceremony in the northern Nigerian city ofKano, where the trial took place.
A dispute over whether DNA testing should be used to verify the identification of victims had held up compensation payments.
Thursday’s payments followed the release of eight results of DNA tests of 546 saliva swabs of claimants, said Abubakar Bashir Wali, who heads the claims verification committee.
“Out of these eight results, four died as a result of their participation in the clinical trial and each is entitled to … $175,000 as full and final settlement of compensation,” Wali said at the ceremony.
The other four claimants suffered deformities and would be paid compensation commensurate with their disabilities, Wali said.
“We are pleased that these four individuals, the first group of qualified claimants…have received compensation,” Pfizer said in a statement it issued from New York.
The statement described the initial payments as a “milestone in the implementation of the settlement agreement reached by Kano state government and Pfizer”.
“The compensation cannot replace my loss, but will only cushion the hardship the drug trial caused me and my family,” Hauwa Umar, who lost a child, said between sobs.
Outside the ceremony, a group of claimants accused the compensation committee of unnecessary delay in the verification and payment of claims.
“It is frustrating that 10 months after taking over 500 swabs for DNA tests only eight results have been released despite assurance that the results would be out within six weeks,” Surajo Hassan said.
Hassan said his nephew suffered deafness from the trial.
“The procedures contained in the settlement agreement are quite cumbersome, and we appeal to all stakeholders to be patient…,” Wali said at the ceremony.
The payments were part of a $75 million out-of-court-settlement reached between Pfizer and Kano state government in July 2009 over the drug trial.
The trial occurred during a meningitis epidemic that, according to Pfizer, killed nearly 12,000 people.
Pfizer says it was given approval from government authorities and about 200 children were involved in the trial, half of whom were treated with Trovan. It has argued that Trovan helped save lives.
But France-based medical charity Doctors Without Borders, which was at the time urgently trying to treat meningitis victims in Nigeria, has harshly criticised Pfizer over the trial.
March 3rd, 2011
By: Catherine Donaldson-Evans
The parents of a Texas toddler who died suddenly from meningitis are blaming the tragedy on contaminated alcohol wipes.
Sandra and Shanoop Kothari are suing the company that makes the now-recalled pads, saying they were tainted with deadly bacteria that infected their 2-year-old son Harrison while he was in the hospital, their lawyer told AOL Health.
Tests revealed the little boy died from acute bacterial meningitis brought on by a strain normally associated with food poisoning called Bacillus cereus. It doesn’t usually factor in to hospital infections.
“The loss is devastating,” the Kotharis’ Houston attorney Jim M. Perdue Jr. told AOL Health. “The family is shocked that a company can put out a product that is supposed to sterilize but can actually contaminate.”
Bacterial meningitis is a serious, life-threatening infection of the tissue covering the brain and spinal cord. It typically affects children, teens, young adults, the elderly and others with compromised immune systems. If it isn’t treated quickly, it can cause brain damage and death.
Harrison had just undergone surgery to remove a benign cyst near his spinal cord and brain when the infection suddenly overtook him. Until then, the Kotharis say, their son had been recovering normally. And doctors were just as mystified as his family.
“They had no explanation as to how he contracted it,” Harrison’s mother Sandra Kothari, 37, told MSNBC in the family’s sole media interview. “They know it’s rare in the hospital.”
After a week in the hospital last fall, the child was about to go home when he fell terribly ill.
“This child was healthy and on his way to being discharged,” said Perdue. “His recovery had gone very well, and he was infection-free.”
That all changed when the bacterial infection spread suddenly the day before he was released. The toddler deteriorated quickly, and within six hours of the meningitis developing, he was brain-dead, Perdue said. He was taken off life support the next morning, on December 1, 2010.
“He suffered two massive seizures at about midnight on the night before he was supposed to be released,” Perdue told AOL Health. “It happened very fast.”
The family was devastated, and didn’t understand what took their son’s life. But a month later, the Food and Drug Administration announced a widespread recall of all alcohol prep wipes made by the Triad Group because they were contaminated with Bacillus cereus. The Kotharis realized those were the very swabs that had been used on their little boy.
“These wipes were used in his care every single day, multiple times a day,” his father Shanoop Kothari, 38, told MSNBC. “We’re confident that that’s the cause. There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”
Children’s Memorial Hermann Hospital in Houston, which performed Harrison’s procedure and treated him afterwards, confirmed that the alcohol pads they used on the boy had been manufactured by Triad.
The Kotharis’ sued the Wisconsin company on Sunday for gross negligence and are seeking undisclosed damages in their son’s death, Perdue said. Triad has yet to respond to the claim, he told AOL Health.
“The recall … was very quiet. It did a very insufficient job of informing users,” he said. “This product is in school nurses’ offices, home medicine cabinets — not just on hospital shelves. It’s everywhere.”
The Triad Group has declined media requests for comment about the recall or the lawsuit.
FDA spokesman Christopher Kelly said the family-owned company “did everything correctly” in alerting the government agency about the voluntary mass recall, according to MSNBC. He declined to comment further or say whether other infections have resulted from the contamination.
The notice Triad issued on January 5 said they were recalling all lots of alcohol wipes, swabs, swabsticks and pads “out of an abundance of caution,” MSNBC.com reported. The company said they’d gotten one report of a mild skin infection from Bacillus cereus, but warned that using the tainted wipes “could lead to life-threatening infections, especially in at-risk populations, including immune-suppressed and surgical patients.”
The bulletin made no mention of how the products may have been contaminated in the first place. The pads are used in many hospitals and sold at chains including Walgreens and CVS.
February 21st, 2011
The UK’s Medical Defence Union said it knew of a handful of recent cases in which children were given flu vaccines unsuitable for their age group.
Some of the jabs in the seasonal flu vaccine programme are not licensed for children under four.
Already “excellent” programme delivery would be improved by reducing errors, the Department of Health (DoH) said.
A spokeswoman for the department said: “It is the responsibility of the doctor or nurse giving the vaccine to check and ensure it is the right vaccine for the patient.”
Last year the DoH published a warning against using some flu vaccines after reports that some youngsters had suffered febrile convulsions following the jab.
Officials said it was important that youngsters aged over six months in at-risk groups – such as asthma sufferers or those with a compromised immune system – received the vaccine, but care should be taken to use the right one.
It warned against giving the jabs Enzira or CSL Biotherapies generic influenza vaccine, marketed by Pfizer, to children under five.
There are about 10 flu vaccine brands in use.
In the last five years the MDU said it had received 108 reports of errors in immunising children using all types of jab, including against meningitis.
In a statement, it said: “The MDU has received a number of calls from members on its advice line recently where there has been a mix-up over the type of vaccine administered to children.
“In addition, a survey of cases reported to the MDU has revealed that 108 immunisation errors were reported over the last five years.
“Of these, 98 (90%) involved children and three concerned doctors administering the incorrect seasonal influenza vaccine to children.”
MDU medico-legal adviser Dr Jacqui Phillips said that although the number of adverse incidents is low considering the numbers of immunisations given, “vaccine errors do represent a sizeable proportion of the medication incidents notified to the MDU”.
“Not all seasonal flu vaccines are suitable for children and GPs need to ensure that neither they nor practice staff administer the incorrect ones,” she said.
The MDU recommends doctors and practice nurses thoroughly check records prior to administering a vaccine.
December 30th, 2010
In April 2009, Pfizer reportedly reached a tentative agreement on lawsuits regarding the vaccine trials it had conducted in 1996. Pfizer tested Trovan, an oral antibiotic, on children of Nigeria’s Kano state. To avoid the lengthy clinical trial process required by the Food and Drug Administration, Pfizer decided to expedite the production of Trovan.
It tested its efficacy on Kano children during a meningitis epidemic, with the aid of the non-profit, Doctors Without Borders. This bypasses national and international standards on medical ethics and put the lives of the Kano children in danger.
Since the testing, there has been one civil suit and one criminal case in both the Kano State and Federal High Courts. The Pfizer lawyers have worked closely with a former Nigerian Head of State on a $75 million settlement. The breakdown of the settlement would provide $10 million for legal fees; $30 million to the Kano State government; and $35 million to participants and families.
The US government was fully aware of the cases against Pfizer in Nigeria and helped Pfizer develop a new framework to conduct future testing in Nigeria. Pfizer considers Nigeria to be a major growth market and is working hard to restore its image there.
February 26, 2010
The Wall Street Journal
The Food and Drug Administration on Wednesday approved a new version of the widely used children’s vaccine Prevnar.
The current Prevnar vaccine is given to infants and toddlers to prevent seven strains of bacteria known as streptococcus pneumoniae that cause a range of illnesses like ear infections, pneumonia, bloodstream infections and meningitis, an infection of the covering of the brain and spinal cord.
February 11, 2010
By David Gutierrez
The steady medical advance against viruses and bacteria that many experts were trumpeting in the early days of vaccines and antibiotics seems to have stalled, if not reversed. The ongoing emergence of new and increasingly drug-resistant diseases is now causing many to question whether the war against microbes is one that can ever be won.
“It is a war of attrition,” said David Livermore of the United Kingdom’s Health Protection Agency. “There have been points where we have been advancing, and points when we have had to beat a retreat. If we were having this conversation 20 years ago, for instance, we would be celebrating the vaccine for bacterial meningitis.”
The news these days contains less of celebration and more of alarm. Even with H1N1 swine flu now appearing less dangerous than originally thought and infection rates of the superbug Methicillin-resistant Staphylococcus aureus (MRSA) falling in the United Kingdom, widespread antibiotic use and a globalized world have made the processes of pathogen evolution and spread faster than ever before.
The threat from the highly lethal H5N1 bird flu – a mere mutation away from a highly contagious form – has not abated, and other infectious threats thought long vanquished continue to rear their heads. China, for example, is currently battling an outbreak of pneumonic plague caused by Yersina pestis, the same bacterium that wiped out a third of Europe’s population as the Black Plague. Meanwhile, longer lifespans have encouraged the emergence of suberbugs such as Clostridium difficile, which preferentially targets elderly patients who have already been treated with antibiotics.
“Sensible prescribing is part of the answer, but we also need new antibiotics,” Livermore said. “It’s not one of the most attractive areas for pharmaceutical companies as people don’t take them for very long, unlike treatments for heart disease or cancer.”
“We will always be at war with microbes,” said Primrose Freestone of the University of Leicester. “Their genetic promiscuity is impressive.”
September 20, 2009
By Paul Stokes
Over a third of GP surgeries have seen patients suffering complications after being misdiagnosed with swine flu including at least three deaths, a survey suggests.
Family doctors have reported effects ranging from mild adverse reactions to the antiviral drug Tamiflu to severe case of tonsillitis, meningitis and pneumonia.
Three out of 205 family doctors and practice managers surveyed by the health magazine Pulse reported a patient dying after being misdiagnosed.
Ninety one percent of those polled called on the Government to review its policy of offering Tamiflu to all patients with swine flu symptoms.
The findings have been published within days of Government figures showing a jump in the number of swine flu cases in the last week.
Experts have been predicting a second wave of the disease will hit the UK in the winter months after a lull during the summer break.
There have been 67 deaths linked to the virus in England, nine in Scotland, two in Northern Ireland and one in Wales.
More than 1.3 million people have been assed via the National Pandemic Flu Service for England with 522,890 collecting anti-viral drugs.
The Government is currently waiting for European regulators to license a swine flu vaccine before issuing it to health workers and at-risk groups across the UK.
Earlier this month prescribing experts called for the NHS to urgently review the use of Tamiflu, with concerns that the public has been misled about the effectiveness of the drug.
One GP, who did not want to be identified, told Pulse that a patient had died from meningitis after being wrongly diagnosed over the telephone.
Two other practices, in Dorset and Wiltshire, also reported that one of their patients had died. There has been a range of lesser side-effect to anti-viral treatment including, diarrhoea, vomiting and lethargy.
Dr Ellen Wright, a GP in Greenwich, south London, whose son contracted swine flu early in the first wave, said mild adverse reactions to anti-viral drugs had been widely reported.
She added: “There have been a lot of complications, especially in children given it in schools at the beginning of the outbreak, and I suspect that is what a lot of GPs have been seeing.”
A family doctor in Derbyshire reported the case a three year old girl who was diagnosed with swine flu and prescribed Tamiflu by the National Pandemic Flu Service.
She was later found to have bacterial pneumonia and admitted to hospital a few days later.
The GP said: “It was unlikely she ever had swine flu. It is near-impossible to diagnose a febrile illness over the phone, and I am afraid one could miss meningitis or other serious illnesses by presuming it is wine flu.”
Another GP in Tyne and Wear reported that one of her patients who was initially thought to have swine flu was later diagnosed with salmonella.
The patient was later admitted to hospital after extreme dehydration as a result of the food poisoning.
A deal has been struck with GPs in the UK, who will receive £5.25 for each dose of the swine flu vaccine they give to patients.
It is hoped that at-risk groups, such as those with diabetes or asthma, will be able to get their normal seasonal flu jab at the same time.
However, GPs are being told not to hold off starting the seasonal flu vaccine programme until the swine flu vaccine arrives.
A total of 132 million doses have been ordered by the UK Government – enough for the entire population with two doses each.