The science against the flu vaccines and Tamiflu: why they are ineffective, unnecessary, and bad medicine
NOTE: What follows are the notes, references, and excerpts from multiple sources that I pulled together for personal use and to support the opinions I offered during a series of interviews. This work was never intended for publication, however, after a widely published interview, I was asked to share the information of which I spoke. Therefore, I am making these informal notes available on my blog. I apologize for any materials that are not fully referenced and attributed. I will correct any omissions as soon as time allows.
As a physician and former editor of the medical journal, Ocular Immunology and Inflammation, I know something about immunology, inflammation, and vaccines. For more than 15 years I’ve researched and analyzed the science and pseudoscience underlying the U.S. vaccine program. What I’ve found is that the science is irresponsibly poor. In fact, it appears to be intentionally contrived to deceive the public with vaccine industry funded weak and biased observational studies.
However, because the vaccine industry stakeholders are more powerful and wealthier than any other industry in the history of the world, they have been extremely successful at using deceptive marketing to promote inadequately tested, ineffective, and unsafe vaccines.
I also know the difference between real, honest, independent, transparent science, and the fake, dishonest, financially biased/bought-and-paid-for pseudoscience being pumped into medical journals by the pharmaceutical industry and their physician co-conspirators. Nowhere is the scientific fraud and betrayal of public trust more manifest than in the promotion of untested and unsafe vaccines like the flu vaccine.
Unlike many of my vaccine-administering-and-profiting-physician colleagues, I have no financial interests, biases, or delusions regarding vaccinations. Therefore, I have no motivation to misrepresent the facts, ignore or deny the risks, fail to fulfill the legal and ethical requirement of informed consent, fear-monger and bully patients into receiving a medical intervention from which I personally profit. Furthermore, unlike my indoctrinated colleagues that have never read beyond the sales brochures that accompany the delicious free lunches delivered by their charming and attractive pharmaceutical representatives, I don’t arrive at my conclusions and base my medical recommendations on industry sponsored pseudoscience. I actually work hard to find and analyze high-quality independent science. After having spent years analyzing the science of the flu vaccine, the only conclusion that I or any reasonable, open minded, free-thinking physician can come to is that the flu vaccine is bad medicine.
Unfortunately, the public is being heavily marketed poor science and egregious lies carefully contrived to mislead the public into believing that the flu vaccine is “the best defense against the flu,” is good medicine, and that this drivel is based on solid science. However, systematic reviews, like that from the Cochrane Collaboration, say that the flu vaccine scientific research is heavily influenced by industry. Yet, despite the best efforts of industry to mislead us into believing otherwise, the Cochrane meta-analysis of 90 plus research studies conclude that the flu vaccine is neither effective nor recommended. I agree with the Cochrane Collaboratives expert and unbiased conclusions. To the Cochrane conclusion, I add my own opinion: the flu vaccine is really bad medicine.
The facts are, the risk to benefit ratio makes it very bad medicine. Many years it's completely ineffective, like it was in 2015. The WHO and CDC completely missed their predictions of the 4 (out of hundreds) of viruses they thought would be circulating and causing illness in America. In 2015, they struck out and every dose given to our children was of NO BENEFIT and therefore, ALL RISK.
Much the same thing happened in 2016. In fact, if you live in Oklahoma you may recall the story of McCloud Public School in McCloud, OK. The school was heavily vaccinated after a free flu vaccination program hit the school. Nevertheless, one teacher died and many other teachers and students came down with the flu. Despite (or because of) their flu vaccinations, the school had to cancel classes for almost two weeks.
At best, the flu vaccine reduces the absolute risk of contracting the flu by about 4-5%. Many years, flu vaccine effectiveness has been even less effective due to mis-predicting the viral strains that ultimately arrived in the U.S. In these years, the flu vaccine may offer a meaningless 1-2% decrease in the absolute risk of becoming infected by influenza.
Influenza A and B strains only represent about 10-17% of the circulating viruses responsible for causing cold and flu like symptoms.
The bottom line is that the flu vaccine is neither good medicine nor good science. It is, however, big money, and that is the primary driver behind the annual drive to increase uptake of the bad medicine we call the “flu shot.”
Please, don't take my word for it. Do your own research. Here's my evidence:
The Alliance for Human Research Protection provides a perfect summary of the Cochrane Collaboration’s 2014 meta-analysis:
This is the season that many Americans are advised-even pressured–to get flu shots. Indeed, flu shots are being hawked at every drug store chain. But what does the evidence show about the effectiveness of the flu vaccine when vaccinated and unvaccinated groups are compared?
In 2014, the Cochrane Collaboration reviewed 90 studies and concluded that the preventive effect of the flu influenza vaccine on healthy adults is small: at least 71 people would need vaccination to prevent one case of influenza (95% CI 64 to 80). They also found that vaccination shows no appreciable effect on working days lost or hospitalization.
The highly credible Cochrane Collaboration should discourage healthy people from getting the flu shot:
“The results of this review seem to discourage the utilisation of vaccination against influenza in healthy adults as a routine public health measure.
As healthy adults have a low risk of complications due to respiratory disease, the use of the vaccine may be only advised as an individual protection measure against symptoms in specific cases.”
“This review includes 15 out of 36 trials funded by industry (four had no funding declaration). An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to the vaccines. The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in light of this finding.”
“...industry funded studies were published in more prestigious journals and cited more than other studies...”
“...reliable evidence on influenza vaccines is thin...”
“...there is evidence of widespread manipulation of conclusions...”
“... the content and conclusions of this review should be interpreted in light of this finding.”
So, it would be prudent to be highly skeptical about the pronouncements and recommendations of public health officials about the value or necessity of various vaccines.
But wait! There’s more:
In 115 participants, those who received trivalent influenza vaccines had a 440% higher risk of acute respiratory infection associated with confirmed non-influenza respiratory virus infection (RR, 4.40; 95% CI, 1.31–14.8) compared to placebo recipients.
In this study, the vaccinated cohort experienced 4.4 times more respiratory infections than the control group that did not receive vaccinations. Let that sink in for a moment.
The mainstream media is doing their best to minimize this devastating study showing a high correlation (7.7-fold) between flu vaccines and miscarriages:
In a nutshell, what the authors found is that women who had received an H1N1 flu shot in the 2010–11 season and who then received a normal flu vaccine in the 2011–12 season were dramatically more likely to have a spontaneous abortion. How much more likely? Here’s what the study says:
Among women who received pH1N1-containing vaccine in the previous influenza season, the aOR in the 1–28 days was 7.7 (95% CI 2.2–27.3); the aOR was 1.3 (95% CI 0.7–2.7) among women not vaccinated in the previous season.
Read the package inserts. Flu vaccines have never been tested on pregnant women. However, post-marketing surveillance is clearly showing that the flu vaccine is dangerous to a developing fetus. How the CDC and doctors can justify recommending the flu vaccine to pregnant women defies my understanding.
About 46% of Americans get the flu shot annually. That's about 146 million people. Medicare pays $25 on average for each flu shot. (The actual price paid out by Medicare and insurers varies from $5 to more than $50, sometimes as much as $100.) Let's just use the $25 as a national average for all insurers. At that rate, the annual flu shot is a $3.8 billion industry. Perhaps that is why it is now so broadly prescribed despite it's effectiveness for a very specific and narrow group of people. Another interesting fact, the average cost to produce each flu shot is about $10. The average co-pay/out of pocket cost for most people for the flu shot is about $10. So, that insurance money seems to be mostly profit.
One insurer paid a wide variety of prices for the "free" flu shots given out at clinics, according to California Healthline and Kaiser Health News.
The Affordable Care Act mandates that health insurers cover all federally recommended vaccines -- including the flu shot -- at no charge to patients, meaning insurers foot the entire bill.
Kaiser Health News looked at what its own insurance carrier, Cigna, paid for those free flu shots. At the high end, it shelled out $85 for a flu shot given at a Sacramento, California, doctor's office that was affiliated with Sutter Health, one of the largest hospital chains in the state.
Further south, in Long Beach, Cigna paid $48 for a shot. Prices in the Washington, D.C., area went even lower, to $40 per shot at a CVS in Rockville, Maryland, and to $32 per shot at a CVS in downtown Washington that's less than 10 miles away from the Rockville location.
Medicaid, on the other hand, pays far less for the flu shot -- $15 in the District of Columbia and $19 in Connecticut.
One expert told KHN that the variation has nothing to do with the cost of the drug, but stems from secret negotiations between health plans and providers. While patients are expected not to care since the shot is free to them, these costs come back to bite in the form of higher premiums -- which is one of the major complaints about the ACA.
This is an appropriately critical analysis and indictment of the lack of evidence supporting the recommendation for the flu vaccine for everyone:
By Eric A. Biondi, MD, MS
Assistant Professor of Pediatrics, Pediatric Hospitalist, University of Rochester Medical Center, Rochester, New York
December 21, 2015
“The bottom line is this, the flu vaccine is an ineffective and potentially injurious medical intervention that lacks evidence for its universal recommendation. It’s promotion is based on money, not health. There are hidden financial conflicts of interest everywhere in this discussion. I have no such conflicts of interest. I have no financial interest. I care about health, science, and the integrity of the medical profession. I cannot recommend the flu vaccine for anyone.”
Influenza vaccination is a yearly ritual. The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend annual influenza vaccination for all healthy persons 6 months of age or older who are without contraindications.
In a 2015 interview published in The Atlantic, Tom Jefferson, head of the Vaccine Field Group at the Cochrane Database Collaboration (the world's leading producer of evidence-based medical reviews), voiced serious reservations about the data supporting influenza vaccine recommendations, stating that "The vast majority of the studies [are] deeply flawed. Rubbish is not a scientific term, but I think it's the term that applies."
A critical look at the evidence raises further questions about the flu shot recommendations.
A 2012 Cochrane review examining the efficacy of pediatric influenza vaccination noted that:
...industry-funded studies were published in more prestigious journals and cited more than other studies, independent of methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to [influenza] vaccines... reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies.
And a 2014 Cochrane review examining use of flu vaccine in healthy adults, including pregnant women, concluded that:
[Influenza] vaccination shows no appreciable effect on working days lost or hospitalization.
If the data supporting widespread influenza vaccination are weak, then why do such organizations as the AAP, ACIP, and the US Centers for Disease Control and Prevention (CDC) support a widespread influenza vaccination policy? As is so often the case, to understand the present, we must examine the past.
The 1918-1919 influenza pandemic, which occurred concurrently with World War I, killed approximately 50 million people around the world. Despite little understanding of the etiology of the pandemic, physicians began administering various vaccines to soldiers in an attempt to stop the spread of the disease.
During World War II, the US Army, eager to prevent a recurrence of 1918, supported influenza vaccine development efforts by such scientists as Jonas Salk. This early flu vaccine was studied in the military in 1944 and found to decrease episodes of illness with a temperature above 99°F—a promising result, but not evidence of an impact on serious clinical outcomes. A subsequent evaluation in 1947 found that "the incidence of disease was no different in vaccinated and unvaccinated individuals."
In other words, by the late 1940s a vaccine for influenza had been developed, but there was no evidence that it prevented serious outcomes. Nevertheless, the vaccine was released for use in the general population.
Then, in 1957, a new pandemic struck. The "Asian flu," although not as severe as the 1918 pandemic, would eventually cause 1-2 million deaths worldwide.A vaccine was manufactured, and millions of doses were administered in the United States in response. The vaccine had no appreciable effect on the trend of the pandemic.
Vaccine proponents felt that the failure of the vaccine was explained by the immunization campaign being too little, too late. As a result, in 1960, national health experts recommended, for the first time, routine annual vaccination, with emphasis on high-risk groups, including those over the age of 65 years and individuals with chronic illness. By the early 1960s, routine influenza vaccination was generally adopted as a policy, with very little supporting evidence.
After several years of this policy, the CDC decided to evaluate its impact. In 1964, Alexander Langmuir, MD, MPH, then the chief epidemiologist at the CDC, published a paper that "reluctantly concluded that there is little progress to be reported. The severity of the epidemic of 1962-1963...demonstrates the failure to achieve effective control of excess mortality." The paper questioned whether widespread influenza immunization "should be continued without better evidence to justify the major costs to the general public." Despite this, annual vaccination campaigns were continued.
In 1968, the CDC finally performed a randomized, double-blind trial to examine the effect of vaccination on morbidity and mortality. The authors concluded that "Despite extensive use of influenza vaccines...attainment of [improved morbidity and mortality] has never been demonstrated." Nevertheless, flu immunization continued.
In 1976, H1N1 "swine flu" appeared, and a large-scale effort to immunize as many Americans as possible was launched. However, the anticipated levels of disease did not appear, and an epidemic of paralytic Guillain-Barré syndrome in recipients of vaccine led to the program's cancellation. An analysis in 1977 by the CDC concluded that influenza control had been "generally ineffective" and that statistically valid community trials were needed.
In 1995, a major review from the US Food and Drug Administration acknowledged the ongoing "paucity of randomized trials" and warned about serious methodological flaws in many existing flu vaccine studies.
In 2000, the CDC performed a placebo-controlled trial and found that "vaccination [when compared to placebo] may not provide overall economic benefits in most years."
Nonetheless, in 2004, the AAP recommended annual influenza immunization for young children, household contacts, and healthcare providers.
Vaccination coverage recommendations continued to expand, and now during every flu season, we watch commercials by retail pharmacies telling us about the importance of getting the flu shot. The fact that the AAP recommends "mandatory" flu vaccination for healthcare providers means that eventually clinicians could be fired for not getting vaccinated.
A 2012 systematic review and meta-analysis examined the efficacy and effectiveness of licensed influenza vaccines in patients with confirmed influenza illness. The authors confirmed that the original "recommendation to vaccinate the elderly was made without data for vaccine efficacy or effectiveness." The main message was that we need a better vaccine and better studies to demonstrate its effectiveness.
Despite the lack of high-quality data supporting the value of the flu shot, widespread vaccination policy might still be reasonable if observational studies consistently showed a benefit. However, the observational studies cited by flu shot proponents are frequently flawed.[22,23,24,25,26,27,28] In many studies, relevant clinical outcomes are ignored in favor of immunogenicity (ie, the ability to elicit an antibody response). "Influenza-like illness" (ie, cold symptoms) is frequently measured instead of serious outcomes, such as pneumonia or death. When these more serious outcomes are examined, there is often a failure to control for healthy user bias—the propensity for healthier people to do such things as receive annual check-ups, eat healthier foods, and get the flu shot. So, although it's true that people who get flu shots live longer, it may have nothing to do with actually getting the flu shot.
A 2005 study of a 33-season, national data set attempted to reconcile the reduced all-cause morbidity and mortality found in some observational studies of influenza vaccination with the fact that "national influenza mortality rates among seniors increased in the 1980s and 1990s as the senior vaccination coverage quadrupled." In this study, the authors conclude that:
"[Our] estimates, which provide the best available national estimates of the fraction of all winter deaths that are specifically attributable to influenza, show that the observational studies must overstate the mortality benefits of the vaccine...[even during two pandemic seasons] the estimated influenza-related mortality was probably very close to what would have occurred had no vaccine been available."
The rationale for flu immunization as a national health priority is that influenza is a disease with serious complications, such as pneumonia, hospitalization, and death.[5,13,28] If the reason for influenza vaccination is that flu is such a serious disease, then the relevant outcomes are whether vaccination improves morbidity and mortality from the flu. However, after decades of vaccine use, it is hard to detect any public health impact. This is in stark contrast to other routine vaccinations, such as polio and Haemophilus influenzae type b, where the introduction of the vaccine led to obvious decline of the disease.
We are pediatricians, and we believe in childhood immunizations. Many vaccines have provided immense public health value. We simply question whether the policy of routine influenza vaccination has outpaced the data supporting its use.
Influenza vaccination now supersedes many other priorities of public health (such as obesity, illiteracy, and high school dropout), and we question whether so much time, effort, and money should be dedicated to flu vaccination while these other national healthcare priorities remain on the back burner.”
(from the Biondi article)
1960, with very little supporting evidence, the flu vaccine became an annual routine and matter of public policy.
1964 the chief epidemiologist at the CDC published a paper that concluded
Despite this, annual vaccination campaigns were continued.
1968, the CDC finally performed a randomized, double-blind trial to examine the effect of vaccination on morbidity and mortality.
Nevertheless, flu immunization continued.
1976, H1N1 "swine flu" appeared,
1995, a major review from the FDA...
2000, the CDC performed a placebo-controlled trial and found that "vaccination [when compared to placebo] may not provide overall economic benefit in most years."
2004, the AAP recommended annual influenza immunization for young children, household contacts, and healthcare providers.
2005 study of a 33-season, national data set attempted to reconcile the reduced all-cause morbidity and mortality found in some observational studies of influenza vaccination with the fact that "national influenza mortality rates among seniors increased in the 1980s and 1990s as the senior vaccination coverage quadrupled." In this study, the authors conclude that:
2012, systematic review and meta-analysis examined the efficacy and effectiveness of licensed influenza vaccines in patients with confirmed influenza illness. The authors confirmed that the original "recommendation to vaccinate the elderly was made without data for vaccine efficacy or effectiveness."
Here's a sampling of studies demonstrating the ineffectiveness of flu vaccines. Many of these studies also explain that earlier positive results appear to have been due to various types of bias, and when the bias is removed, the alleged benefits of vaccinating against the flu disappear. There are many more... For another list of additional studies demolishing the claim that the flu vaccine is an effective prevention strategy, see this previous article:
As for the RISK, the flu vaccine is not only highly INEFFECTIVE, it is also the most injurious vaccine compensated by the Vaccine Court system! Which is where you have to go since the vaccine manufacturers and doctors can't be sued for the injuries vaccines cause. If your child has a serious adverse reaction or dies from the flu vaccine, you are most likely on your own. Due to the ridiculous conflicts of interest, it is extremely rare that any case of vaccine injury gets compensated by the Vaccine Court system. Patients injured by vaccines are essentially being judged by the same people that oversee safety and distribution of vaccines: Health and Human Services (the agency over the CDC).
Here's how the vaccine court system works: https://www.youtube.com/watch?v=P1PiR4PkCh0
Thimerosal is a preservative that contains mercury. A single .5 mL dose of vaccine from a multi-dose vial contains 25 micrograms of mercury.
According to the U.S. Environmental Protection Agency, a safe dose of mercury is .1 micrograms for every 2.2 pounds of body-weight per day.
Trivalent flu vaccine
No placebo control. Fluad was compared against AGRIFLU.
Contains problematic ingredients:
These terms all describe vaccine induced injury to human immune systems. Vaccines are increasingly shifting ("TH2 shifting") the immune systems of vaccinated individuals into a hyperactive, hyperallergic, hyper-autoimmune state of immune dysregulation.
In my opinion, vaccine induced immune dysregulation is one of the key factors driving the enormous epidemic of childhood allergies and autoimmune diseases today.
Not only is the flu vaccine ineffective at preventing the flu, it may actually be increasing the transmission of flu in the population. Clinical research has demonstrated that when individuals vaccinated for the flu become infected with a strain of the flu not covered by the vaccine, they cough, sneeze, and exhale 640% more infectious viral particles to infect anyone with whom they come in contact.
The route of exposure for natural influenza infection is the respiratory tract, not subcutaneous (SC) or intramuscular (IM) injection. Influenza vaccines artificially changed the route of initial viral protein exposure to SC or IM injection thus stimulating an IgE response to influenza proteins.
Consider dengue virus infection. The initial mosquito bite that injects dengue virus into a person, causes the induction of IgE against dengue proteins.  Upon a subsequent exposure to the dengue virus again, the person develops hives due to a dengue specific-IgE mediated allergic reaction. As the infection (and thus allergic reaction) progresses and more histamine is released, vascular permeability increases. The result is hypotension and dengue shock syndrome.  Basically, a type 1 hypersensitivity reaction caused upon dengue virus exposure following IgE mediated sensitization to dengue viral proteins.
It should therefore not come as a surprise that we are modifying the course of influenza infection such that it is acquiring characteristics of a dengue infection (hives and shock).
As a direct result of the U.S. universal vaccination program, these hypersensitivity reactions are becoming ridiculously and intolerably common in American children today. American children are the most highly vaccinated children on the planet. Thus, their immune systems are increasingly "TH2 shifted" into a hyperactive state of immune dysregulation.
In my opinion, vaccine induced immune dysregulation is one of the key factors driving the enormous epidemic of childhood autoimmune diseases today.
The biological mechanism of vaccine-induced sepsis:
specifically a really important subset of T-cells responsible for attacking intracellular viruses and cancer cells: CD8+ T cells (aka, Cytotoxic T lymphocytes[CTL], killer T-cells).
Cytotoxic T lymphocyte production is vital to combatting intracellular pathogens. Once the virus has invaded your cells, antibody mediated immunity is powerless.
Learn about CTLs at https://www.immunology.org/.../bitesize.../cells/cd8-t-cells
In this study, the treatment cohort experienced 4.4 times more infections than the control group that did not receive vaccinations. Let that sink in for a moment.
Increased Risk of Noninfluenza Respiratory Virus Infections Associated With Receipt of Inactivated Influenza Vaccine
In this study, the vaccinated premature infants experienced sepsis at a greater rather than those who weren't vaccinated:
Adverse Events After Routine Immunization of Extremely Low-Birth-Weight Infants
"This study found an increase in adverse events after the routine immunization of ELBW infants in the NICU, specifically sepsis evaluations, need for increased respiratory support, and intubation."
Is it plausible that bacteria entering via the vaccine needle puncture site could increase the possibility of sepsis? This is not just plausible, this recent paper (2016) argues that we should be performing disinfection before every vaccination precisely to stop sepsis!
"Disinfection should be required for all skin penetrative procedures including parenteral administration of vaccines... Like ‘clean’ surgical site infections, the major pathogens responsible for these events were Staphylococcal species, implicating endogenous contamination as a significant source of infection."
Sepsis, parenteral vaccination, and skin disinfection
Here is a case of death from sepsis after the flu shot that received compensation from the National Vaccine Injury Compensation Program:
No. 12-775V Filed: August 21, 2013
"Damages decision based on stipulation; influenza vaccine; pneumonia; sepsis; systemic inflammatory response; death"
Original article by Dr. Mercola. Edits and amendments by Jim Meehan, MD
OSELTAMIVIR is an antiviral medicine. It is used to prevent and to treat some kinds of influenza or the flu. It will not work for colds or other viral infections. The lowest GoodRx price for the most common version of oseltamivir is around $51.94, 60% off the average retail price of $132.39.
Tamiflu and Relenza are drugs commonly used for the prevention and treatment of influenza in adults and children. Past research has hailed the drugs for reducing hospital admissions and complications as a result of the virus. But in the latest Cochrane Review, recently published in the BMJ, researchers say there is no solid evidence to support such claims.
Tamiflu (oseltamivir) and Relenza (zanamivir) are classes of drugs known as neuraminidase inhibitors. Both drugs are thought to prevent and reduce symptoms of the flu by stopping the influenza virus from spreading inside the body.
At present, Tamiflu is used to combat flu in patients 2 weeks of age and older whose symptoms have not lasted longer than 2 days. It can be used to prevent flu in patients aged 1 year and older. Relenza is used to tackle flu in patients aged 7 years and older and can be used for flu prevention in those aged 5 years and older.
According to the researchers involved in this latest review, including Dr. Carl Heneghan of the University of Oxford in the UK and Dr. Peter Doshi of the University of Maryland School of Pharmacy in the US, both drugs are stockpiled for use against seasonal and pandemic influenza. For example, the US has spent over $1.3 billion on reserves of influenza antivirals.
This stockpiling has been based on international and national recommendations from bodies such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). But what are their recommendations based on?
The team says that for the European CDC, neuraminidase inhibitor recommendations were based on a summary of benefits and harms carried out by the European Medicines Agency (EMA), while other recommendations have been based on the findings of trials from drug manufacturers, such as GlaxoSmithKline (GSK).
In 2009, Cochrane researchers looked to verify the safety and effectiveness of neuraminidase inhibitors. However, drug manufacturers refused to provide full access to clinical trial data of the drugs, which hindered their efforts.
This raised questions as to whether the risks and benefits of influenza antivirals have been accurately reported, and whether they should be stockpiled for the treatment of seasonal and pandemic flu in children and adults.
In 2012, Medical News Today reported on a story detailing how the BMJ were putting pressure on Roche - the manufacturers of Tamiflu - to release trial data for the drug.
FROM THE WEBMD ARCHIVES
Nov. 14, 2012 -- Does the blockbuster flu drug Tamiflu really work?
Nobody knows for sure, claims the prestigious Cochrane Collaboration, a group that issues careful analyses of the evidence behind drugs and vaccines. Cochrane researchers say there's not enough evidence to prove Tamiflu works.
The CDC and the World Health Organization recommend the drug as effective. The FDA and the European Medicines Agency approve Tamiflu for the treatment and prevention of flu.
Tamiflu can lessen symptoms and make flu illness one to two days shorter, the CDC says. It can also help prevent flu illness in people who have come into close contact with a flu patient.
But it’s not a cure-all, says pediatric infectious disease specialist Marcelo Laufer, MD, of Miami Children's Hospital.
"One of the problems is that Tamiflu is seen by the public as a drug that will save you from all cases of the flu," he says. "Tamiflu can decrease the duration of illness by 30% to 40%, and decrease flu severity by about 40% -- but only if taken in the first 36 to 48 hours of illness. And you know that will not happen all the time."
Cochrane researchers, joined by the BMJ (formerly the British Medical Journal), complained that Tamiflu maker Roche is keeping important data from the public. They note that despite requests dating back to 2009, Roche refuses to release crucial data from eight of 10 Tamiflu clinical trials.
"This means that taxpayers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base," Fiona Godlee, BMJeditor-in-chief, wrote in an editorial.
In a letter sent this week to respected Oxford professor John Bell -- a Roche board member -- Godlee warned that too much Tamiflu data is being kept secret.
"There are concerns on a number of fronts: the likely overstating of effectiveness and apparent under-reporting of potentially serious adverse effects," she wrote.
The data in question is what researchers call "patient-level data" collected from each study participant in a clinical trial, with only identifying information removed.
In a response to BMJ, Roche last month issued a statement saying it does not make the data available to protect patient confidentiality.
"Roche provided the Cochrane group with access to 3,200 pages of very detailed information, enabling their questions to be answered," the statement says.
Published: 08 August 2009
In publicly funded health systems with finite resources, management decisions are based on assessments of clinical effectiveness and cost-effectiveness. The UK National Institute for Health and Clinical Excellence commissioned a systematic review to inform their 2009 update to guidance on the use of antiviral drugs for the treatment of influenza. We searched databases for studies of the use of neuraminidase inhibitors for the treatment of seasonal influenza. We present the results for healthy adults (ie, adults without known comorbidities) and people at-risk of influenza-related complications. There was an overall reduction in the median time to symptom alleviation in healthy adults by 0·57 days (95% CI −1·07 to −0·08; p=0·02; 2701 individuals) with zanamivir, and 0·55 days (95% CI −0·96 to −0·14; p=0·008; 1410 individuals) with oseltamivir. In those at risk, the median time to symptom alleviation was reduced by 0·98 days (95% CI −1·84 to −0·11; p=0·03; 1252 individuals) with zanamivir, and 0·74 days (95% CI −1·51 to 0·02; p=0·06; 1472 individuals) with oseltamivir. Little information was available on the incidence of complications. In view of the advantages and disadvantages of different management strategies for controlling seasonal influenza in healthy adults recommending the use of antiviral drugs for the treatment of people presenting with symptoms is unlikely to be the most appropriate course of action.