By Frank Jordans via www.msnbc.com
GENEVA – A group of outside experts will scrutinize the World Health Organization’s response to the swine flu outbreak and likely examine whether the term pandemic was appropriate for what has turned out to be a relatively mild disease, the World Health Organization said Monday.
The review starting later this month will be conducted by around 30 scientists and public health officials, and their initial findings will be presented to member states by WHO Director-General Margaret Chan in May, a senior official told reporters in Geneva.
“The assessment itself is going to address many of the questions which are being raised now,” said Dr. Keiji Fukuda, WHO’s top flu official.
WHO’s pandemic alert scale, or “phases,” and the role that disease severity plays in the global body’s assessment of an outbreak are likely to be among the “critical issues” the group will examine, he said.
Several governments urged WHO last year not to declare swine flu a pandemic, saying it could cause unnecessary alarm if the virus turned out to be harmless. The U.N. health agency went ahead anyway, arguing that the term pandemic signifies only that a new strain is circulating worldwide, but says nothing about how dangerous it is.
Fukuda acknowledged Monday that the choice of words may have to be reconsidered in the future, to avoid confusion and anger from people who believe WHO and others overplayed the threat the virus posed.
“If we look back to the beginning of the pandemic there was a lot of discussion about what do you call these things,” he said. “These things affect how people perceive outbreaks and pandemics so I think it’s one of those issues that we have to think about.”
The expert group, which will include “very well-known scientists,” will hold its first meeting April 12-14 and consultations will probably continue over the course of the year, Fukuda said.
A final report will be presented at the WHO’s annual meeting of member states in May 2011, he said. WHO is holding a separate, internal review of its handling of the outbreak.
Continue reading about Swine Flu Response: Alarmist or Legit?
By S. Humphries, MD
January 22, 2010
original link with references www.medicalvoices.org
H1N1 and seasonal influenza vaccines are now being given to sick hospital patients with or without their doctor’s consent. This is being done despite there being no data on the safety of doing so.
I am a licensed, board-certified nephrologist, otherwise known as a kidney specialist, working in a large, city-based hospital. Because I rarely admit patients to the hospital other than for specific procedures, such as a kidney biopsy, I only recently became aware of my hospital’s policy regarding flu shots for sick people. Waking up to this new rule made me realize that Big Pharma is getting closer and closer to bypassing doctors completely to deliver direct patient “care”.
We have an elaborate electronic charting system at our hospital. All of the medications and procedure orders are placed into the patient’s record by doctors and nurses so that every person has access to all that is happening with the patient. A few weeks ago, I arrived to see my first patient of the day, a patient with a kidney ailment that leaks protein and usually progresses to complete kidney shutdown. When I opened her electronic chart, I expected my section to be empty. Instead, I saw an order for an influenza vaccine with my name on it. Even more shocking was that the order was highlighted bright blue, meaning, the shot had already been given. I thought perhaps I had opened the wrong chart or some sort of mistake had been made. But it was the right file; her name in the upper left hand corner. And my electronic signature was on the page after the order. My patient, with kidney failure and an autoimmune disorder had been given a flu shot without my consent.
I was informed that according to a hospital policy that had been in effect since 2007, a pharmacist is permitted to visit a patient and offer them a flu vaccine. If the patient agrees, the RN is instructed to administer the shot and document the event in the chart. The attending physician’s signature stamp is used to complete the order. No one called to ask, “By the way, your patient wants a flu shot; can we give her one?” I’m not sure what was said to her, but she obviously agreed, and I didn’t need to be involved. The pharmacist had written an order for an injectable substance that I considered toxic and inappropriate for my patient, and it was administered by the RN before I even got to the floor.
My dissatisfaction eventually made it to the Chief of Internal Medicine who challenged me to produce peer-reviewed journal articles in support of my objection. There were dozens of case reports of kidney disease or small blood vessel inflammation following influenza vaccination. In fact, one paper cited 16 patients in its written report(1). Under-reporting of adverse vaccine reactions is a known phenomenon. The National Vaccine Information Center estimates that only about two percent of adverse vaccine reactions ever get reported. It would follow that written and published case reports found in medical journals represent a miniscule sampling of the totality of vaccine injury cases. These implications should evoke at least some curiosity on the part of doctors and health care advocates.
The peer-reviewed literature was delivered to the department head. His initial response was to suggest that future vaccination orders be signed off by another physician so I didn’t have to be involved with the process of a nurse giving a “routine” flu shot. But the point had been missed; flu shots should not be given to sick patients.
I was challenging “routine orders” that had been in place since 2007. The defense for supporting the policy was that no side effects had been reported since the standing order had been instituted. I wondered to myself and then later inquired: How do you know that is true? Is it because nobody filed a formal report? If a patient became more ill after the shot, did you consider his condition to be a side effect of the vaccine, or was it simply called an unfortunate complication to the patient’s current illness? What if the patient was discharged from the hospital but readmitted several weeks later. Was the reason logged simply as a progression of his existing disease…or was the cause an overlooked, delayed side effect of the vaccination? If vaccine reactions are not considered as part of a patient’s differential diagnosis, how do you know? Without taking a vaccine history when considering a timeline of events, how could anybody possibly make the connection between a vaccine and a subsequent illness? How does anyone else know for that matter – that there were no side effects from the “routine” administration of flu shots, ordered by a pharmacist and given by a nurse, without doctor consent? The truth is, there is no real tracking and reporting system in place. And nobody is enthused about trying to start one. What has essentially happened is that the guards have all been told to go home and nobody is thinking to even look for the wolf.
I am sure there are thousands of unreported cases of kidney failure – and a wide range of other serious health conditions – because doctors fail to ask a very simple question as part of the admission evaluation: “When was your last vaccine?” And few doctors suspect any connection because the party line screams, “Vaccines are safe, effective and harmless. They keep people healthy and prevent infection.” If nobody looks, vaccine-related side effects and complications won’t be found.
There was a law passed in 1986, the National Vaccine Injury Compensation Act, that made vaccine manufacturers and administering physicians immune from legal recourse in the event of a vaccine injury. This has given manufacturers a dangerously long leash and has enabled them to push vaccines through FDA approval with little need to create a safe product. Now drug companies have extended their reach into the hospital right past doctors, and put the power to vaccinate in the hands of pharmacists and executive committees, allowing them to make decisions about what is best for a patient.
Continue reading about Vaccination Without Doctor Approval In a US Hospital
WASHINGTON (Reuters) – The United States has not made a decision on whether to cancel or sell any of its orders for the H1N1 vaccine, unlike some countries in Europe, a federal health official said on Thursday.
Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said demand remains steady and the government’s focus is on having as many people vaccinated as possible
“Right now we are at a point where we have ample supply. We’re really encouraging people to get vaccinated. So we haven’t made decisions here in the U.S. about giving back vaccines,” Schuchat told a media briefing.
Germany plans to cancel half the 50 million vaccines it ordered from GlaxoSmithKline (GSK) to combat the H1N1 flu virus, a German health official said on Thursday.
Earlier this week, France canceled over half the H1N1 flu vaccines it had ordered because of the pandemic.
The U.S. government has paid for 251 million doses of bulk vaccine from five makers — Glaxo, AstraZeneca, Sanofi-Aventis, Novartis and CSL Ltd.
Continue reading about No U.S. Decision On H1N1 Vaccine Orders: Official
By Steve Sternberg, USA TODAY
A team of researchers from the USA and Britain on Monday dramatically scaled back estimates of the severity of the swine flu epidemic.
The analysis suggests that the death rate from the current wave of H1N1 flu cases probably will fall in a range that extends from far lower to slightly higher than the estimate of 36,000 deaths caused by seasonal flu in a typical year.
The analysis doesn’t project how many people will contract swine flu but “how bad it will be,” says lead author Marc Lipsitch of the Harvard School of Public Health.
At the low end, the estimates suggest that for every 10% of the population to develop flu symptoms, there will be 1,500 to 2,700 deaths, 6,600 to 11,000 people in intensive care, and 36,000 to 78,000 hospitalizations. At the high end, for the same percentage of the population, swine flu could cause 7,800 to 29,000 deaths, 40,000 to 140,000 people needing intensive care, and 250,000 to 790,000 hospitalizations.
The calculations represent a marked reduction from an August report by the President’s Council of Advisors on Science and Technology. That report proposed a “plausible” death toll that could fall anywhere between 30,000 and 90,000. Lipsitch, who worked on the August report, says the earlier estimate was based on “limited data” because the researchers began their work not long after the virus first surfaced in April, when little was known about the shape of the epidemic to come.
To fill gaps, Lipsitch and his team at Harvard and Britain’s Medical Research Council used data from Milwaukee and New York City. The data confirmed that swine flu has its biggest effect on children younger than 4 and adults 18 to 64. The study appears in the Public Library of Science (PLoS) Medicine journal.
Last month, the Centers for Disease Control and Prevention released its own estimate of the scope of the epidemic. The agency says at least 22 million Americans have gotten the flu since April. About 3,900 have died, including about 540 children.
Beth Bell of the CDC says the fact that researchers used “real live data” lends credibility to the research. She says the estimates roughly agree with those released last month by the CDC.
“It’s an insight into how flu kills,” says institute director Anthony Fauci. Continue reading about Swine Flu Far Less Severe In Latest Calculations
LONDON (AP) — The European Medicines Agency warns that young children given GlaxoSmithKline’s swine flu shot may get a fever after their second dose.
In a statement issued Friday, the European drug regulator said data from GlaxoSmithKline PLC showed a higher number of children aged six months to 3 years had a fever after their second dose of the Pandemrix vaccine, compared with the first. Kids were also more likely to have side effects like muscle pain, drowsiness, and irritability.
The European regulator recommends children get two doses of swine flu vaccine, though Glaxo says one dose is enough.
Glaxo’s vaccine contains an adjuvant, a chemical compound to boost the immune response. It is sold across Europe and Canada.
Another formulation of Glaxo’s vaccine, without the adjuvant, is available in the U.S. Vaccines with adjuvants usually cause more side effects. No flu vaccines with adjuvants are licensed in the U.S.
Last month, Glaxo advised health authorities not to use one batch of its Canadian-manufactured swine flu vaccine in case it triggered life-threatening side effects like anaphylactic shock.
In a press briefing on Thursday, the World Health Organization’s flu chief Keiji Fukuda said that more than 150 million doses of swine flu vaccine have been distributed in more than 40 countries and that they had not seen any evidence to suggest the vaccines caused worrying side effects.
Continue reading about Glaxo’s Swine Flu Shot May Give Kids Fever