Vaccine Nation: Directors Cut
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The body of a baby boy that has been lying in a mortuary freezer for 21 years is to be buried against his parents’ wishes after a council used new powers to formalise his death.
Christopher Blum died aged 4 months after receiving a standard vaccination in hospital in June 1987.
His parents are convinced that he died as a result of a blood infection caused by a contaminated vaccine. However, postmortem examinations gave the cause as sudden infant death syndrome, also known as cot death.
Steven Blum, the boy’s father, has refused repeatedly to sign his son’s death certificate if it gives the cause as cot death, meaning that Christopher could not be buried.
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Last week Enfield Council, North London, used new powers to register Christopher’s death without giving a cause. It has told Mr Blum that he has until August 18 to say where he wants Christopher buried and the wording of a headstone, or the council will make the funeral arrangements itself.Mr Blum, 61, is preparing to challenge the council’s decision in the High Court in a final attempt to halt the burial. Christopher has spent the past 21 years in a freezer drawer marked “Baby Blum: Deceased”. His tiny frame is kept at minus 8C (17.6F) at a weekly cost of £15.
Christopher’s mother, Mary, had taken him to the North Middlesex Hospital to be inoculated against whooping cough, polio and tetanus. He was sick immediately afterwards and that evening was found dead in his cot at the family home in Edmonton, North London.
Mr Blum said that postmortem blood tests showed the baby had a blood infection that he believes may been caused by a contaminated vaccine. He claims that the authorities had insisted that the infection got into the blood sample accidentally in the laboratory. Mr Blum also says that two back-up samples have gone missing and Christopher’s organs cannot be found. “When people hear that Christopher is unburied they think I am some sort of nutter, a crazy person who just can’t let go,” Mr Blum said. “Although my marriage broke up my wife still supports me as do my [three surviving] children.
“The key point about my son’s death is that you cannot have cot death if a cause of death is found. Cot death is an unexplained death meaning nothing untoward can be found for a healthy baby suddenly and unexpectedly dying. In Christopher’s case there was a cause. And that’s why I refuse to accept he was a victim of cot death.”
Mr Blum is billed regularly for Christopher’s stay in the mortuary at North Middlesex Hospital. “Do they really think I want Christopher lying there officially undead?” Mr Blum said.
Enfield Council said that the Registrar General had allowed the authority to register the death this month under new laws that did not require a cause to be given.
“We have kept Mr Blum informed and have asked for his views all along,” a council spokeswoman said. “We have now asked him what arrangements he would like to make regarding his son’s funeral and the wording of the headstone by August 18.”
The longest unresolved case of this kind is that of Helen Smith, a nurse who was 23 when she fell from a balcony in Saudi Arabia in 1979. She remains in a mortuary in Leeds. Her father, Ron, who is 81, refuses to have her buried until it is accepted that she was murdered. Mr Smith said that the city council in Leeds had agreed that his daughter would remain in the mortuary while the circumstances of her death were being contested.
Industry Insider: FDA gripes aired on the internet
The Star Ledger: Thursday, July 24, 2008A group of dissident current and former Food and Drug Administration employees have launched a website, Thoreau-FDA.com, to express their complaints about the agency and to expose what they consider to be improper conduct by those in charge.
In their launch last week, they raised the question of whether managers have the legal or ethical right to direct subordinate scientists to agree to product approvals when those scientists feel they cannot give their personal support.
The purpose of the site, according to its founders, is to “engage U.S. FDA commissioner Andrew von Eschenbach, his successors and FDA upper managers in a public question and answer dialog … to end the entrenched process flaws in FDA’s pre-approval drug review and post-approval regulatory enforcement systems.”
One key flaw, they said, is “the abuse of FDA staff, who do their jobs by making publicly known the existence of harmful and deadly products already approved for, and in, the market.”
Julie Zawisza, a spokeswoman for FDA, said von Eschenbach has set up a system for FDA staff to “feel valued, respected and supported — in a number of areas — but importantly, in expressing their scientific views.”
She said decisions must be made based on science and law in the interest of public health, even if there is disagreement. But Zawisza insisted the process is fair.
“This is an utterly open and transparent process, and our staff are encouraged to express their views and voice their concerns at any time to anyone.” she said. ” I must point out that this does not necessarily mean that one’s professional or personal views will override those of others, or de facto result in an agency decision that any one individual or group of individuals favors or supports.”
– Robert Cohen
Glaxo’s counsel coup
Dan Troy, former chief counsel for the Food and Drug Administration, is joining GlaxoSmithKline as senior vice president and general counsel on Sept. 2.
It’s a coup for Glaxo, since Troy is widely known for being supportive of the pharmaceutical industry.
“Dan shares our vision that it is critical in today’s health care environment that we deliver differentiated products of real value to patients and payers,” Glaxo chief executive Andrew Witty said in a statement. “His wealth of experience in the regulatory legislative area will be of enormous benefit to us and, ultimately, to patients.”
During his tenure at the FDA, according to published reports, Troy instructed agency staff to issue fewer warning letters in the belief they were being ignored, which critics say led to less-effective enforcement of advertising violations.He also laid the groundwork for the current legal battle over pre-emption, which says FDA approval supersedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA argue agency actions are the final word on safety and effectiveness.
A case goes before the U.S. Supreme Court this fall, and the ruling could determine whether patients can sue a drugmaker through state law when a product already has been approved by the FDA.
Troy’s appointment also comes as a Justice Department investigation of Glaxo’s handling of its Paxil antidepressant is widening. Last month, the drugmaker confirmed a previously disclosed Justice Department investigation of marketing practices now includes the U.S. Attorney’s Office in Boston and is being coordinated by the agency in Washington.
This followed a demand by Sen. Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. More recently, the same committee began probing Martin Keller, a Brown University psychiatrist, for his role in studying Paxil.
Troy is a partner at the Sidley Austin law firm in Washington, D.C., where he represents drugmakers and trade groups on issues concerning the FDA and government regulations.
– Ed Silverman/Pharmalot.com
Roche: Doping detective
Italian cyclist Ricardo Ricco, riding in the Tour de France, was caught doping after Roche planted a traceable molecule in a banned stamina-building drug he had taken, according to the World Anti-Doping Agency. The 24-year-old was kicked out of the race last week after testing positive for EPO, or erythropoietin.
Roche included a molecule in the third generation of EPO, called Continuous Erythropoiesis Receptor Activator (CARA), that acted as a flag in drug tests showing when an athlete was using the substance, John Fahey, WADA’s chief, told the Australian Broadcasting Corp.
Until this year’s Tour, the CARA EPO, which is released into the body more slowly than its predecessors, had been thought to be virtually undetectable by drug testers. Fahey said cooperation with drugmakers is the way to fight drug cheats.
“There’s more and more of this occurring,” Fahey said in an interview with Australian Broadcasting. “The more cooperation the scientists can have with the drug companies in the detection of performance-enhancing drugs, the greater the likelihood is they will be detected when tests are undertaken.”
– Ed Silverman/Pharmalot.com
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How “Independent” Are Vaccine Defenders?
Sharyl Attkisson Investigates Vaccine Advocates Taking Funding From The Companies Whose Vaccines They Endorse
WASHINGTON, July 25, 2008(CBS) For years some parents and scientists have raised concerns about vaccine safety, including a possible link to autism and ADD. Many independent experts have sided with government officials and other scientists who say there’s no possible connection. But how “independent” are they? CBS News investigative correspondent Sharyl Attkisson shares here’s what she found.
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They’re some of the most trusted voices in the defense of vaccine safety: the American Academy of Pediatrics, Every Child By Two, and pediatrician Dr. Paul Offit.
But CBS News has found these three have something more in common - strong financial ties to the industry whose products they promote and defend.
The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters. The totals are kept secret, but public documents reveal bits and pieces.
A $342,000 payment from Wyeth, maker of the pneumococcal vaccine - which makes $2 billion a year in sales.
A $433,000 contribution from Merck, the same year the academy endorsed Merck’s HPV vaccine - which made $1.5 billion a year in sales.
Another top donor: Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot just added to the childhood vaccine schedule last month.
Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too - but wouldn’t tell us how much.
A spokesman told CBS News: “There are simply no conflicts to be unearthed.” But guess who’s listed as the group’s treasurers? Officials from Wyeth and a paid advisor to big pharmaceutical clients.
Then there’s Paul Offit, perhaps the most widely-quoted defender of vaccine safety.
He’s gone so far as to say babies can tolerate “10,000 vaccines at once.”
This is how Offit described himself in a previous interview: “I’m the chief of infectious disease at Children’s Hospital of Philadelphia and a professor of pediatrics at Penn’s medical school,” he said.
Offit was not willing to be interviewed on this subject but like others in this CBS News investigation, he has strong industry ties. In fact, he’s a vaccine industry insider.
Offit holds in a $1.5 million dollar research chair at Children’s Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck, Rotateq, which has prevented thousands of hospitalizations.
And future royalties for the vaccine were just sold for $182 million cash. Dr. Offit’s share of vaccine profits? Unknown.
In the ER the other night, we weighed Nicholas - he weighed in at 54.4 pounds. On June 1, he was 48 pounds and on May 1, he was 43 pounds. I’m a little concerned with the rapid weight gain. I know that hbot will make them feel better and we did see him start eating a bit more - but the increased appetite tapered off.
He doesn’t snack, doesn’t really eat junk or sugary foods. Any ideas? Feel free to comment.
Oregon Grape Extract (for yeast) added today. 3 drops at dinner.
Goal dose is 15 drops 3 times/day.
Every now and again, we get a glimpse of the NT Nicholas. Today was one of those days.
Daddy was outside mowing the lawn and Nicholas was watching him through the window. Once Daddy was done, he had to blow off all of the grass clippings because we’ve been so busy the grass got so high. Once Daddy was done blowing the clippings onto the sidewalk, Nicholas went outside and helped him sweep them all up and toss them into a bag. He held the dustpan while daddy swept and then he took turns being the one doing the sweeping. Things, for that short time, were very different. We weren’t worried that he would go running out into the street - or down the street.
People who don’t have a child with autism just don’t know what we go through on a daily basis. How huge and significant this short time is to us. They don’t have to worry that taking their child outside of their home for 5 minutes could end up in having a screaming, tantruming child which you have to pick up and carry him back inside completely against his will, kicking and screaming all the way - and then deal with the fall-out from that lousy five minutes making you wish you had never taken him outside. They can take walks in the park with their child trailing behind them and not worry where their kid will be. They can sit on the bench on the park and talk on their cell phones while their kids play. They don’t have to keep their eyes on their children for 60 seconds out of every single minute focusing on nothing else but their child. They can slowly walk through the grocery store reading food labels while their child contently sits in the cart. They don’t have to assess a new situation or surroundings for things that might end up being issues for their kids. They can just be. One day we’ll get there.
As I am sitting here researching supplements, Nicholas is watching Bear in the Big Blue House. When Bear looks for Shadow, he sings a song, “Where oh where oh where is Shadow? Where oh where oh where is Shadow? Where can Shadow be?” Nicholas just sang along to the song. All the words. No approximations - his singing was perfect.