Do Flu Vaccines Really Work? A Skeptic’s View
by ilene - March 2nd, 2010 12:07 am
Do Flu Vaccines Really Work? A Skeptic’s View
By Eben Harrell, courtesy of TIME
In December, the Centers for Disease Control and Prevention (CDC) launched a public health campaign in the U.S. encouraging vulnerable patients — particularly the elderly — to "protect yourself and the ones you love against flu: GET VACCINATED!" At least one flu-vaccine researcher disagreed with the message: Tom Jefferson, an epidemiologist with the prestigious Cochrane Collaboration, which has headquarters in Britain.
Jefferson and colleagues have published several systematic reviews of existing studies on the efficacy of influenza vaccines. Weighing the data, they conclude that there is insufficient evidence to indicate that flu vaccines reduce infection rates or mortality, even in the elderly. Jefferson, a former British army doctor now based in Rome, spoke with TIME about his quest to spur further research into flu vaccines.
On Feb. 16, the Cochrane Library published your updated review of all major studies on the efficacy of flu vaccines for the elderly, some of the results of which you believe to be preposterous. Can you explain?
We looked at studies on vaccines in the elderly and in health care workers who work with the elderly, and we found an implausible sequence of results. We have studies that claim up to 90% effectiveness against death from all causes [in inoculated patients compared with the nonvaccinated]. If you were to believe that evidence, you would believe that flu vaccine is effective against death not only from influenza, but also from heart attack, stroke, hypothermia, accidents and all other common causes of death among the elderly. That is quite clearly nonsense.
This is not to say that these and other studies, taken together, suggest that vaccines don’t work for the elderly. The answer is a question mark. We don’t know what protection, if any, vaccines offer. I don’t think that’s a bad thing. Uncertainty is the motor of science. We need large studies to find out.
Why do you think such studies have not been done?
I don’t know. We’ve known for years that we needed proof one way or the other, and governments have not taken any notice of this. It’s an extraordinary situation.
One argument I’ve heard is that it would be unethical to compare vaccines against a placebo because you would be withholding crucial treatment from patients. Do you agree?
No. We don’t know these vaccines work, so you can’t…
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Updating the H1N1 Update
by ilene - December 31st, 2009 1:58 pm
Updating the H1N1 Update
Watching and Waiting
Ukraine
Vaccines
Tamiflu Resistance
Dr. Niman vs. WHO, ECDC and CDC
by Ilene with guest expert Dr. Henry Niman at Recombinomics
Watching and Waiting
While the numbers of new cases of swine flu have been declining in many regions, including the United States, it is too early to know whether or not there will be subsequent waves of disease.
"Based on my experience with new diseases and the lessons learned from past pandemics, I think we should remain cautious and observe the evolution of the pandemic over the next six to 12 months before declaring victory," World Health Organization Director General Margaret Chan tells Swiss newspaper Le Temps. (World Health Official Says Swine Flu Still a Threat)
Although the WHO is remaining "cautious," changes in the virus’s genome that increase its virulence and resistance to Tamiflu are becoming more common. Dr. Henry Niman, expert in flu virus evolution, believes another wave of illnesses will occur in early 2010. In addition, he believes resistance to Tamiflu will become "fixed," similarly to how this genetic change evolved in the seasonal H1N1 virus. (See Flu Update: Tamiflu resistance and Ukraine update, and Efficacy of Roche’s Flu Drug Tamiflu In Doubt, by David Phillips.)
WHO: H1N1 swine flu pandemic will stick around for another year
The World Health Organization warned government health authorities to remain vigilant on the H1N1 swine flu pandemic, saying the virus could mutate before vaccines can help it dissipate.
The World Health Organization is confident that the H1N1 swine flu pandemic will be under control in a year’s time – however, WHO officials warned global governments to remain vigilant for any mutations in the troublesome bug.
Dr. Niman believes this wave will be more severe than the previous two--but not due to random mutations. Rather, this will result from the process of recombination. Due to recombination, increasingly greater transmission of aggressive variants (D225G, D225E and D225N) and Tamiflu-resistant viruses will occur.
Ukraine
I’ve reprinted two recent articles at Recombinomics, with my comments in blue.
The WHO Surprise on D225G / D225N H1N1 Fatalities, Recombinomics Commentary
After considering the current available virological, epidemiological and clinical findings and following discussions on an earlier draft with WHO and its European-based
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Flu Update: Tamiflu resistance and Ukraine update
by ilene - December 20th, 2009 12:52 pm
Roche’s Tamiflu and the Swine Flu
By Ilene
Part I: Tamiflu resistance
Part 2: Flu virus changes/Ukraine/update
Tamiflu (oseltamivir) has been a big seller this year, with global sales soaring 362% to $1.93 billion in the first nine months. Driven by the threats of a swine flu pandemic, governments have been stockpiling the drug to the tune of $1.32 billion. (See Efficacy of Roche’s Flu Drug Tamiflu In Doubt, David Phillips):
According to David Phillips:
Allegations have surfaced that Swiss drug maker Roche has misled governments and physicians alike on the efficacy of its popular drug Tamiflu in preventing complications, such as hospitalization from pneumonia or death, in otherwise healthy people afflicted with the flu — seasonal or the H1N1 (swine flu) version. If the company is unconvincing in refuting such claims, more than its reputation could be sullied.
Leveraging global concerns over avian and swine flu, Roche has seamlessly raised awareness of the purported need to treat the complications associated with the seasonal flu too. The company has successfully challenged conventional wisdom — that “rest and aspirin” be the preferred treatment option for seasonal flu — with marketing campaigns that resonate with reassuring efficacy claims for Tamiflu (oseltamivir)… [See Tamiflu media updates].
A scarcity of published data in the medical literature motivated the nonprofit research group Cochrane Collaboration to investigate — and verify — Tamiflu’s alleged efficacy claims, particularly on the drug’s effect on the risk of hospital admission and complications in otherwise healthy people with influenza. The Cochrane review and a linked investigation undertaken jointly by the British Medical Journal and the local Channel 4 News cast doubt on the efficacy and safety of Tamiflu — and also raises disturbing questions on the drug’s promotional and marketing activities condoned by regulators on both sides of the Atlantic.
Investigators disclosed that an often cited meta-analysis used as evidentiary support was based entirely on ten trials funded by Roche, only two of which were published in peer reviewed journals. The Cochrane reviewers could find no independently funded trials of Tamiflu for healthy adults. Troubling, too, former employees of the medical communcations company hired by Roche were alleged to have ghost written some of the manuscripts….
Continue reading Efficacy of Roche’s Flu Drug Tamiflu In Doubt here .
As noted…
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Swine Flu Virus: Changes and Consequences
by ilene - December 14th, 2009 12:52 pm
Swine Flu Virus: Changes and Consequences
By Ilene with guest expert Dr. Henry Niman
Background
Dr. Henry Niman heads the research company Recombinomics Inc. Recombinomics has a small group of researchers who analyze the sequence data from viral samples isolated from patients diagnosed with swine flu. Its website is a terrific place to find the newest information available.
Dr. Niman has kindly been answering my questions regarding the H1N1 virus, its evolution, and the implications regarding the spread of disease. Because the terminology may be unfamiliar, a brief introduction may be helpful towards better understanding both the H1N1 virus and the swine flu disease.
Recombination
Flu viruses, including the H1N1 varieties, are known for quickly changing genetically. Recombination is the driver of rapid molecular evolution, a process whereby small bits of genetic information pass between viruses so a virus may quickly acquire a genetic variation that has previously evolved and already exists in the viral reservoir (the pool of viruses circulating in a population). Unlike sporadic mutations, recombination reflects the acquisition of genetic material that has withstood the Darwinian test of time. Compared to sporadic mutation, recombination is a quicker, non-random mechanism for genetic change.
Changes in the H1N1 viral genome are natural. The viral reservoir consists of wild-type viruses (the predominant viruses) and low levels of variants carrying a variety of different sequences called “polymorphisms.” While recombination is not the currently favored theory regarding how flu viruses evolve, Dr. Niman believes it is the correct theory. The theory of recombination as a mechanism for genetic change has led to accurate predictions about how the flu virus would evolve as infection rates increase. As the size of the viral reservoir continues to expand, viruses with genetic differences, “polymorphisms,” become more evident.
Ukraine Outbreak
The outbreak in Ukraine was initially described in many media reports as a new lung-blackening “mystery disease,” leading to many false and misleading Internet stories. According to Dr. Niman, it was clear from the start that H1N1 was killing an unusually high number of previously healthy young adults… (See Flu News: D225G Follow-up)
Dr. Niman wrote a number of commentaries on the rising death toll and the need to make the sequences public. He predicted the deaths would be associated with a receptor binding domain change in the wild-type H1N1 virus (the predominant virus) to…
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The H1N1 Pandemic: Is a Second Wave Possible?
by ilene - December 11th, 2009 11:35 pm
The H1N1 Pandemic: Is a Second Wave Possible?
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By Alice Park, courtesy of TIME Since early November, cases of H1N1 have continued to decline nationwide, and scientists keeping track of the numbers say that as pandemics go, 2009 H1N1 may turn out to be a mild one — at least for the time being.
The question now on health officials’ minds is: Will there be a second wave of cases in the new year? The answer depends on whom you ask. "We took an informal poll of about a dozen of some of the world’s leading experts in influenza," Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), told reporters recently. "About half of them said, Yes, we think it’s likely that we’ll have another surge in cases. About half said, No, we think it’s not likely. And one said, Flip a coin."
It is an accurate reflection of how unpredictable the influenza virus can be. Although flu activity has been waning for the third week in a row, health officials warn that there are still four to five months left in the official influenza season, plenty of time for the virus to make its rounds and find new hosts. "The story of pandemics, and the story of H1N1 in general, is the story of persistent uncertainty where we never quite know what we are going to get or when," says Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at the Columbia University Mailman School of Public Health.
How severe the current H1N1 pandemic seems depends on what you use as a measuring stick. Compared with previous pandemics, like the 1918 Spanish flu, which killed 20 million people and infected up to 40% of the world’s population, or even the far less deadly 1957 and 1968 bouts with a strain of H1N1 influenza similar to the 2009 strain, things don’t seem as bad this time around. Fewer people are getting severely ill when infected, and fewer have died or required hospitalization from the flu than in previous pandemics.
Marc Lipsitch, an epidemiologist at the Harvard School of Public Health, and his colleagues studied the course of the 2009 H1N1 pandemic last spring in two cities — New York and Minneapolis — and determined that 0.048% of people who developed symptoms of H1N1 died, and 1.44% required hospitalization. Based…
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New Study: Hepatitis B Vaccine Triples the Risk of Autism in Infant Boys
by ilene - October 2nd, 2009 9:50 pm
Weekend off-topic reading. I found this fascinating. - Ilene
New Study: Hepatitis B Vaccine Triples the Risk of Autism in Infant Boys
Courtesy of David Kirby writing at the Huffington Post
"The science is largely complete. Ten epidemiological studies have shown MMR vaccine doesn’t cause autism; six have shown thimerosal doesn’t cause autism."-- Dr. Paul Offit, "Autism’s False Prophets"
"16 studies have shown no causal association between vaccines and autism, and these studies carry weight in the scientific industry."-- Dr. Nancy Snyderman, NBC Today Show Medical Editor
Conventional wisdom holds that the autism-vaccine question has been "asked and answered," and that at least 16 large, well-constructed epidemiological studies have thoroughly addressed and debunked any hypothesis that childhood vaccination is in any way associated with an increased risk for autism spectrum disorders.
But there are several critical flaws in such an oversimplified generalization, and they are rarely given close examination by public health experts or members of the media.
To begin with, it is unscientific and perilously misleading for anyone to assert that "vaccines and autism" have been studied and that no link has been found. That’s because the 16 or so studies constantly cited by critics of the hypothesis have examined just one vaccine and one vaccine ingredient.
And, the population studies themselves have had critical design flaws and limitations.
The current US childhood immunization schedule calls for 28 injections with 11 different vaccines against 15 different diseases by two years of age. Of those 11 vaccines, only the Measles-Mumps-Rubella (MMR) shot has been studied in association with autism, (although a CDC study of an MMR-plus-chickenpox vaccine did show that the risk for febrile seizures in infants was doubled.) Meanwhile, those 11 vaccines contain scores of ingredients, only one of which, thimerosal, has ever been tested in association with autism.
It is illogical to exonerate all vaccines, all vaccine ingredients, and the total US vaccine program as a whole, based solely on a handful of epidemiological studies of just one vaccine and one vaccine ingredient. It is akin to claiming that every form of animal protein is beneficial to people, when all you have studied is fish.
Now, a new study has shown that giving Hepatitis B vaccine to newborn baby boys may triple the risk of developing an autism spectrum disorder.
An abstract of the study was published in the September, 2009…
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Swine Flu Vaccine: Watching For Side Effects
by ilene - September 27th, 2009 3:37 pm
The decision regarding whether or not to get vaccinated for swine flu, or have your kids vaccinated, may be easy for some, but is not for others. It depends on how you perceive and value the risks. As is often the case with medical interventions, the risks are not fully known or understood. Even if you’re lucky enough to believe you’ve obtained valid risk percentages to compare, you cannot truly know whether your assumptions accurately reflect reality. And your numbers certainly don’t factor in the unknown.
So as the swine flu vaccine program gets underway, several government-sponsored projects will attempt to determine how safe the vaccine really is. We have a rather unique opportunity to learn a lot more while serving as subjects in this grand experiment.
Go ahead, leave comments and share your thoughts… – Ilene
Swine Flu Vaccine: Watching For Side Effects
(WASHINGTON) — More than 3,000 people a day have a heart attack. If you’re one of them the day after your swine flu shot, will you worry the vaccine was to blame and not the more likely culprit, all those burgers and fries?
The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.
"Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone," said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.
Health authorities hope to vaccinate well over half the population in just a few months against swine flu, which doctors call the 2009 H1N1 strain. That would be a feat. No more than 100 million Americans usually get vaccinated against regular winter flu, and never in such a short period.
How many will race for the vaccine depends partly on confidence in its safety. The last mass inoculations against a different swine flu, in 1976, were marred by reports of a rare paralyzing condition, Guillain-Barre syndrome.
"The recurring question is, ‘How…
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CDC leery of estimates about swine flu’s toll
by ilene - August 27th, 2009 1:47 am
Swine Flu News
CDC leery of estimates about swine flu’s toll
By LAURAN NEERGAARD, AP Medical Writer Lauran Neergaard
WASHINGTON – Government health officials are urging people not to panic over estimates of 90,000 people dying from swine flu this fall. "Everything we’ve seen in the U.S. and everything we’ve seen around the world suggests we won’t see that kind of number if the virus doesn’t change," said Dr. Thomas Frieden, head of the Centers for Disease Control and Prevention…
While the swine flu seems quite easy to catch, it so far hasn’t been more deadly than the flu strains seen every fall and winter — many people have only mild illness. And close genetic tracking of the new virus as it circled the globe over the last five months so far has shown no sign that it’s mutating to become more virulent.
Still, the CDC has been preparing for a worst-case flu season as a precaution — in July working from an estimate slightly more grim than one that made headlines this week — to make sure that if the virus suddenly worsened or vaccination plans fell through, health authorities would know how to react.
On Monday the White House released a report from a group of presidential advisers that included a scenario where anywhere from 30 percent to half of the population could catch what doctors call the "2009 H1N1" flu, and death possibilities ranged from 30,000 to 90,000. In a regular flu season, up to 20 percent of the population is infected and 36,000 die…
Continue Swine Flu article here.>>
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Hospitals May Face Severe Disruption in Swine Flu’s U.S. Return
by ilene - August 25th, 2009 8:02 am
Swine Flu Update:
Hospitals May Face Severe Disruption in Swine Flu’s U.S. Return
By Tom Randall and Alex Nussbaum
Aug. 25 (Bloomberg) — Swine flu may hospitalize 1.8 million patients in the U.S. this year, filling intensive care units to capacity and causing “severe disruptions” during a fall resurgence, scientific advisers to the White House warned.
Swine flu, also known as H1N1, may infect as much as half of the population and kill 30,000 to 90,000 people, double the deaths caused by the typical seasonal flu, according to the planning scenario issued yesterday by the President’s Council of Advisers on Science and Technology. Intensive care units in hospitals, some of which use 80 percent of their space in normal operation, may need every bed for flu cases, the report said.
The virus has sickened more than 1 million people in the U.S., and infections may increase this month as pupils return to school, according to the Centers for Disease Control and Prevention. If swine flu patients fill too many beds, hospitals may be forced to put off elective surgeries such as heart bypass or hernia operations, said James Bentley with the American Hospital Association.
“If you have 1.8 million hospital admissions across six months, that’s a whole lot different than if you have it across six weeks,” said Bentley…
Continue Swine Flu article here. >>
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Study Suggests HPV Vaccine Is Safe, but Doctors Wary
by ilene - August 19th, 2009 11:12 am
Study Suggests HPV Vaccine Is Safe, but Doctors Wary
By Alice Park, courtesy of TIME
Generally the fact that a vaccine appears to be as safe as the manufacturer had promised shouldn’t be news. It should be a given. But when it comes to the controversial vaccine against human papillomavirus (HPV), even the most straightforward data come with an asterisk.
The vaccine, called Gardasil and manufactured by Merck, is one of the first immunizations to protect against a cancer — in this case, cervical cancer, which is most commonly caused by infection with HPV. Because the virus is sexually transmitted, the Centers for Disease Control and Prevention (CDC) recommended in 2006 that girls get the vaccine at ages 11 and 12, before they become sexually active, so they have the best chance of avoiding the cancer and genital warts caused by HPV. States joined in, attempting to mandate HPV vaccination for school entry, but parents balked, in part because of concerns about encouraging promiscuity. It didn’t help that girls were prone to fainting after getting the shot or that more than two dozen girls died shortly after getting immunized.
To address those concerns, researchers at the CDC and the FDA, which keep track of adverse events related to vaccines once they are approved, now report in the Journal of the American Medical Association (JAMA) that the rate of adverse events associated with the 23 million doses of Gardasil administered since 2006 is similar to the prelicensing rate among the 21,000 girls and young women who tested it in clinical trials and to that of other vaccines.
That should be reassuring. But the study did find that users of Gardasil faint and develop blood clots more often than those receiving other shots. The clots are extremely rare, though. In about 90% of these cases, the girls may have been more vulnerable to developing clots because they smoked or were overweight or on birth control pills. "Was it that this age group also tends to have these risk factors or did the vaccine have some sort of role?" asks the CDC’s Dr. Barbara Slade, lead author of the paper. "We really don’t know."
It’s that uncertainty that is beginning to bother many physicians about the HPV vaccine. According to Dr. Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association and author of an editorial that JAMA…
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Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...
Ilene is editor and affiliate program
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