Flu Crazy

CDC admits flu shot link to febrile seizures

2013-11-12T19:46:00.000-08:00

The CDC now admits that there is a verifiable link between the flu shot and seizures in children ("febrile seizures").

In a conversation with medical web site WebMD, Frank DeStefano, confirms the link when children get the flu shot with other vaccines (specifically the pneumococcal PCV13 vaccine).

"This adds perhaps 60 seizures per 100,000 children. And the good news is, if it were to happen, it would be on the day of or the day after vaccination, so parents can know what to look for," Frank DeStefano, MD, MPH, of the CDC's Immunization Safety Office, tells WebMD.

Although the link is confirmed, the CDC is not making any change to their blanket flu shot recommendation.

The FDA first investigated the uptick in febrile seizures over two years ago. http://flucrazy.blogspot.com/2011/01/fda-investigates-unusual-spike-in.html

http://children.webmd.com/vaccines/news/20110223/small-seizure-risk-with-flu-pneumococcal-vaccines

Don't get the flu shot

2013-08-16T23:15:00.001-07:00

There are good and valid reasons to get the annual seasonal flu shot, especially if you have an underlying medical condition such as asthma, heart disease, or a weakened immune system.

But, for the vast majority of healthy people (under the age of 65), there are also good and valid reasons NOT to get the annual influenza shot. Although some are distrustful of all vaccines, there are specific reasons to be wary of the influenza vaccine;

these include:

• Complications related to the flu shot. Many people report feeling sick after getting the flu shot, and children have been reported to suffer from febrile seizures. Reports of narcolepsy and adverse reactions to the flu shot appear to be on the rise.

• The flu shot is not entirely effective. You can still get the flu, even if you are vaccinated. So, while you incur the risks for adverse side effects you may still get the flu.

* The effectiveness of the anti-flu treatment Tamiflu has been called into question, and it appears that it does not lessen hospital stays. Further it appears some of the results of the trials were intentionally withheld when they painted a picture of doing exactly the opposite of the intended affect. There was one trial that seemed to suggest that Tamiflu lessened the ability of the immune system to fight influenza.

• Lack of legal recourse (civil) especially in the US if you are harmed by the flu shot. A US Supreme Court decision (BRUESEWITZ et al. v . WYETH LLC) sided with vaccine makers in a case involving a Pennsylvania girl who was denied a claim in vaccine court and was not allowed for file a claim in civil court. The fact is that if you lose your case in “vaccine court” you will have no further legal recourse. Some, including Supreme Court Justice Sotomayor, argue that there are now no serious consequences for vaccine manufacturers if they produce a faulty product and that no other industry in America has such a comprehensive “get out of jail free” card.

• Most healthy people do not require hospitalization for the flu, even though suffering from the flu is uncomfortable.

• Washing your hands frequently, eating healthy, and getting plenty of sleep are very good ways to avoid getting the flu.

• The majority of health care providers (approximately 60%) choose NOT to get the flu shot every year. Even the risk of termination of their job is not great enough of a threat to convince them to risk getting the flu shot. [ Edit note: in 2012, the numbers have improved. One study shows that 60% + of health care providers are now getting the flu shot. But, this improvement has happened after employers threatened termination for non-compliance. The fact that so many health care providers are still leery of getting the flu shot speaks volumes. ]

• Recommendations for getting the flu shot vary widely from country to country. For example, most countries in Europe only recommend those aged 65 or over get the flu shot (with no underlying medical condition).

• The odds of dying from the flu are minuscule. The CDC’s numbers for mortality are suspect, at best. Influenza is grouped with pneumonia statistics, thus blurring any meaningful comparisons. But, even the CDC admits that most deaths occur among the elderly population, yet still insist that everyone (over 6 months of age) get the flu shot. The is especially at odds with reality, given that pediatric deaths associated with flu are now at historically low levels.

• Valid reasons to mistrust government and pharmaceutical pronouncements, including the influence of money in the political process. The recent case of trial tests of the antibiotic drug “Trovan” on African children, allegedly without parental consent, illustrates problems with the industry. Recent news reports about past horrors amplify the point. *

• Valid reasons to mistrust media outlets. Many newspapers, web sites, and television news programs are beholden to vast pharmaceutical advertising dollars. Anyone who questions the necessity of flu shots is instantly branded a kook or “dangerous.” An outlet that does not follow the party line risks losing advertising dollars to other programs that are not so choosy about what they publish.

• Not all flu shot formulas are the same. Risks vary by formula. The nasal flu shot, Flumist, contains a live, albeit weakened, influenza virus.

So, we will continue to remain skeptical of the CDC's blanket recommendation that everyone over the age of 6 months get the flu shot.

As with all medical decisions, you should ask your doctor if you should get the flu shot. But, also ask him/her if they have gotten the flu shot themselves.

Hopefully they will be honest with you.

See also: Flu Shots: Panacea or Propaganda? http://www.huffingtonpost.com/dr-mark-hyman/flu-shots-panacea-or-prop_b_831696.html

*AP IMPACT: Past medical testing on humans revealed
http://www.washingtonpost.com/wp-dyn/content/article/2011/02/27/AR2011022700988.html

European Centre for Disease Prevention modest recommendation for flu shots

2013-08-16T23:00:00.003-07:00

The European Centre for Disease Prevention and Control continues to advise that only older adults and people with pre-existing conditions get the flu shot.

Unlike the US CDC which recommends blanket immunization of the population, the Europeans take a much more measured approach.

There are various reasons for this, but the most likely reason is that there is not as much pressure from the pharmaceutical industry or they are better able to resist the pressure compared with the US regulators.

http://ecdc.europa.eu/en/healthtopics/seasonal_influenza/basic_facts/Pages/factsheet_general_public.aspx

Flu cases drop again. 2,362 Lab Confirmed cases

2013-02-08T08:55:00.004-08:00

Flu cases, as reported to the CDC have dropped again to 2,362 laboratory confirmed cases (FluView: http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html).

This marks 5 consecutive weeks that lab-confirmed cases have dropped. But, since CDC keeps revising numbers for previous weeks, this is hard to pin down. Research requires keeping previous sets of reported numbers to compare with current numbers.

But, the big picture is that out of US population of 312 million, only 2,362 cases have been confirmed.

We are still waiting for major media outlets to pick up this story. They continue to trumpet the CDC’s flu scare message.

By the numbers…

For Week 5 (ending Feb 2, 2013)

A (H3) 1026

2009 H1N1 74

A (Subtyping not Performed) 640

B 622

TOTAL 2,362

Confirmed flu cases drop for fourth straight week in 2013

2013-02-01T13:03:00.001-08:00

Laboratory-confirmed cases of influenza have dropped for the fourth week in a row, according to a report published by the CDC (FluView: http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html).

Despite hard evidence of a declining flu season, CDC is still preaching the gospel of “flu is widespread” with the media playing along as willing lap dogs. And, nearly every news story trumpets the benefits of flu treatments such as Tamliflu and Relenza, even though a review of clinical trials provides compelling reasons to doubt the efficacy of these treatments.

Also, news reports rarely mention hard numbers. The public might become wary of the “flu is widespread” story if the number of laboratory confirmed cases were widely published.

However we will happily report them here:

Number of laboratory-confirmed cases for 2013 -

week 1 6287

week 2 6104

week 3 4427

week 4 2701

One wonders how long the CDC will be able to keep up this charade.

CDC confirmed flu cases show steep drop

2013-01-22T08:27:00.000-08:00

Reported laboratory confirmed flu cases were down sharply for the most recent reporting period (ending Jan 12, 2013).

CDC reported that out a total 12,360 specimens only 3,638 were positive for influenza (source FluView: http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html).

Breakdown:

A (H3) 1,603

2009 H1N1 45

A (Subtyping not Performed) 1,355

B 635

But, it is hard to know what to believe when it comes to reported numbers. Numbers for weeks 51 and 52 of 2012 have been revised (up) since they were first released. So, the numbers for the week ending Jan 12, 2013 may be revised in the future. It is troubling why the numbers are being tinkered with. CDC receives a certain number of specimens per week. This number should not change. But, it appears that CDC is releasing numbers before the final counts are in (thus lessening their usefulness).

As previously reported on this blog, the hysteria surrounding flu this season appears to be overblown. And now the hard numbers are bearing this out.

Calling BS on the Flu Hysteria for the week ending Jan 5, 2013

2013-01-14T14:32:00.000-08:00

The Numbers Do Not Add Up

Who to believe, the CDC or the New York State Department of Health?

Last week, New York Governor Cuomo declared a public health emergency due to an outbreak of influenza. But, the numbers just don’t add up. The CDC has published numbers that show the new number of laboratory confirmed cases of flu nationwide totaled 4,222 (for week 1, 2013), down from a high of 5,108 for the last week of 2012.

But, New York State is claiming that [laboratory-confirmed] “influenza was reported in all 57 counties plus New York City. There were 4,059 total reports, a 7% decrease over last week,”
according to the weekly STATEWIDE INFLUENZA SURVEILLANCE REPORT, for the week ending January 5, 2013 (source: http://www.health.ny.gov/diseases/communicable/influenza/surveillance/2012-2013/flu_report_current_week.pdf).

The numbers just do not add up. New York State cannot account for nearly 100% of all flu cases nationally.

Weekly confirmed flu cases reported to CDC (source FluView, http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html).

YEAR WEEK number of confirmed cases

2012 40 162

2012 41 197

2012 42 299

2012 43 339

2012 44 408

2012 45 618

2012 46 841

2012 47 1328

2012 48 1995

2012 49 3366

2012 50 4449

2012 51 5417

2012 52 5108

2013 1 4222

TOTAL # , LAB CONFIRMED (NATIONALLY) CASES FOR THE SEASON: 28,749

TOTAL H3N2v FOR THE SEASON: 0

Flu Season Appears To Be Ebbing, 4222 cases reported, but flu scare marches on

2013-01-11T11:14:00.000-08:00

The influenza (“flu”) season appears to be ebbing. For the week ending Jan 5, there were 4,222 laboratory confirmed cases reported to the CDC (source: FluView http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html).

Out of a US population of 312 million, your chances of getting the flu are approaching zero.

But, the drumbeat of the flu scare marches on.

Approximately 130 million doses of the flu vaccine have been administered. Millions of prescriptions for antivirals, like Tamiflu, have been written (even though the effectiveness this treatment has been called into question).

And, although nearly 27,500 people went to the hospital for flu-like symptoms, only 1/6 actually had the flu, so the vast majority of these symptoms were for something else.

By the numbers --

Laboratory confirmed cases reported to the CDC for the week ending Jan 5, 2013:

A (subtyping not performed) 1,550

A (H3) 1,783

A (H1) 0

B 853

2009 H1N1 36

H3N2v 0

Total: 4,222

CDC Flu Scare Campaign Off To An Early Start

2012-12-04T12:55:00.003-08:00

The CDC held a briefing this week in which they claimed significant increases in flu activity, but not once did they mention any real numbers. However, by scouring information on the CDC site it becomes apparent that real flu activity is still virtually non-existent.

In essence, the CDC’s claim is based on earlier numbers where there were virtually no laboratory verified cases, compared to now where there are several hundred verified cases (at most) per type of flu. Yes, you read this correctly – there are still only hundreds of flu cases, per type (out of a US population of 312 million). This is a significant increase in percentages, but not in real numbers.

Why is the CDC intent on scaring people into getting flu shots? There are many possible reasons for this, but there are just as many reasons (and perhaps more) that the average person should be leery of getting the flu jab.

And, nowhere else but in the United States do medical authorities urge blanket coverage of the entire population.

The CDC loves to spout numbers such as the potential for 49,000 people to die. This is irresponsible and the number has been proven to be inaccurate. The CDC concedes that this number is an estimate and is grouped together with pneumonia deaths. And, of course, neither the CDC nor any other authority in the US actually tracks flu deaths – so the numbers are entirely made up out of whole cloth. You will note that the use of vague language, like “could” or “as many as.”

The real scandal is that media outlets lap this up as if this was real news (and is “truth”). Whatever happened to investigative journalism?

H3N2

According to the briefing, the big culprit this year is H3N2, yet the number of reported, verifiable cases (according to their own site, for the most recent weekly period) is, you guessed it, zero.

Here are the numbers, as reported by CDC, (for the most recent reporting period, for the week of November 24):

A (H1): 0

A (Unable to sub-type): 0

A (H3): 755

2009 H1N1: 11

A (subtyping not performed): 701

B: 678

H3N2v: 0

We remain skeptical of the CDC’s blanket recommendation and urge citizens to get the facts for themselves.

Risk benefit assessments needed for H5N1 Bird Flu research

2012-10-10T06:51:00.001-07:00

Risk benefit assessments needed before H5N1 Bird Flu experiments continue.

Approximately 9 months ago, a voluntary moratorium on Bird Flu research went into effect to allow scientists time to figure out how to conduct research without the findings falling into the hands of terrorists or others who might create bio-terrorism strains.

Right now, H5N1 ("Bird Flu") rarely is transmitted to humans; when it does, it is often times fatal. So, studying the potential for mutations of this strain are reasonable, with the goal of developing ways to protect the public. But, creating dangerous mutations in the lab raises the specter of potential accidental releases of the mutations. And publishing research on these mutations also poses a potential risk in making it easier for terrorists to create their own mutations.

The LA Times reports that key players in the debate have weighed in. But, things are currently at a standstill.

Our take:

While it is important that research continue, reasonable steps should be taken to protect the public.

Perhaps a registry of influenza scientists can be created, with only authorized scientists given access to the most risky information. More general information (minus dangerous details) can be made available to the public on the findings of the research.

While it may seem anti-democratic to guard scientific knowledge, we see this as no different than withholding information on “how to build a bomb.” Sharing scientific knowledge is important and one of the best ways to quickly find solutions. But, true influenza researchers should have no problem with safeguarding the public while at the same time sharing key data with only those who are working to find answers to this complex challenge.

Swine flu rears its ugly little head under the radar.

2012-10-05T21:28:00.000-07:00

Pigs on the loose and under the radar.

A woman in Ohio dies after exposure to a pig at an agricultural fair… Pigs in Korea carry H1N2.

An article in New Scientist provides a worrisome look at the potential for the global resurgence of Swine Flu (H1N2).

Author Debora MacKenzie points to examples from Korea to Ohio to show the dangers of this strain of the flu. MacKenzie describes how Robert Webster, of St. Jude Children's Research Hospital, placed "H1N2 flu virus, from the lungs of a pig slaughtered in South Korea in 2009, into the noses and windpipes of three ferrets. " The ferrets perished. This is a cause for concern as ferrets process influenza in much the same way as humans.

Of the experts contacted by New Scientist, all agreed that further research is needed to find out what mutations will make the Swine Flu dangerous to humans.

CDC report shows flu virtually nonexistent in the US

2012-10-04T08:04:00.003-07:00

The weekly influenza surveillance report prepared by the Influenza Division of the CDC shows that influenza ("the flu") is virtually non-existent in the United States.

Influenza A (H1) has zero reported cases. A (H3) shows 21 cases with 2009 H1N1 at 2 cases.

There were 31 cases of Influenza A where sub-typing was not performed. There were 102 cases of Influenza B reported and 7 cases of H3N2v.

Given the population of the United States (312.8 million), these numbers are statistically insignificant.

Flu Crazy 200 - The Largest Pharmaceutical Companies in the world, by size

2012-03-20T15:55:00.000-07:00

Flu Crazy 200 - The Largest Pharmaceutical Companies in the world, by size

Johnson    & Johnson
Pfizer Inc
Roche Holding    Ltd.
Novartis AG
Merck &    Co.,
GlaxoSmithKline    plc
Sanofi SA
Abbott Laboratories
Novo-Nordisk A/S
Bayer AG
AstraZeneca plc
Bristol-Myers Squibb Company
Amgen,Inc.
Eli Lilly
Teva Pharmaceutical Industries
Gilead    Sciences,Inc.
Takeda Pharmaceutical Company
Celgene    Corporation
Allergan,Inc
McKesson Corporation
Astellas Pharma    Inc.
Shire PLC
CSL Ltd.
Fresenius SE
Alexion    Pharmaceuticals, Inc.
Valeant    Pharmaceuticals    International,
Cardinal Health, Inc.
Daiichi    Sankyo    Company
Eisai Co.,Ltd.
Sun Pharmaceutical Industries
Regeneron Pharmaceuticals, Inc.
AmerisourceBergen Corporation
Mylan Inc
Chugai Pharmaceutical Co
Perrigo    Company
Vertex Pharmaceuticals Inc
Forest Laboratories,Inc
Elan Corporation plc
Life Technologies Corporation
Herbalife Ltd.
Mitsubishi Tanabe Pharma
UCB S.A.
Watson Pharmaceuticals,    Inc.
Taisho Pharmaceutical Holdings
Merck KGaA
Ono Pharmaceutical Co
Aspen Pharmacare Holdings
Kyowa Hakko Kirin
Grifols    S.A.
Hospira,Inc
Yunnan Baiyao Group
Dr. Reddy's Laboratories
Shanghai Pharmaceuticals Holding
Actelion Ltd.
Jiangsu    Hengrui    Medicine
Shionogi & Co
Cipla Ltd
Kangmei    Pharmaceutical    Co.,
IDEXX    Laboratories,    Inc.
Shandong    Weigao    Group
Lupin    Limited
Hisamitsu    Pharmaceutical    Co.,
Dainippon    Sumitomo    Pharma
Endo    Pharmaceuticals    Holdings
Warner    Chilcott    PLC
Galenica    AG
H.    Lundbeck    A/S
BioMarin    Pharmaceutical    Inc.
PT    Kalbe    Farma
GlaxoSmithKline    Pharmaceuticals    Ltd
Dabur    India    Ltd
Santen    Pharmaceutical    Co.,
Sichuan    Kelun    Pharmaceutical
Ranbaxy    Laboratories    Ltd.
Tianjin    Tasly    Pharmaceutical
Chr.    Hansen    Holding
Celesio    AG
Shenzhen    Hepalink    Pharmaceutical
Richter    Gedeon    Nyrt.
Beijing    Tongrentang    Co.,
Orion    Oyj
Salix    Pharmaceuticals    Ltd
Medipal    Holdings    Corp
Shanghai    Fosun    Pharmaceutical
Suzuken    Co.,    Ltd.
Cadila    Healthcare
Jilin    Aodong    Medicine
China    Resources    Sanjiu
A    Meda    AB
Jazz    Pharmaceuticals    PLC.
Techne    Corporation
United    Therapeutics    Corporation
Amylin    Pharmaceuticals,    Inc.
Hualan    Biological    Engineering
ARIAD    Pharmaceuticals,    Inc.
ONYX    Pharmaceuticals,    Inc.
Krka,    tovarna    zdravil,
Harbin    Pharmaceutical    Group
Zhejiang    Hisun    Pharmaceutical
Questcor    Pharmaceuticals,    Inc.
Shijiazhuang    Yiling    Pharmaceutical
Seattle    Genetics,    Inc.
Qualicorp    SA
Ipsen    SA
Hikma    Pharmaceuticals    plc
Miraca    Holdings    Inc.
Fleury    S.A.
Alkermes    Public    Limited
GlaxoSmithKline    Consumer    Healthcare
Kobayashi    Pharmaceutical    Co.,
Denki    Kagaku    Kogyo
Medicis    Pharmaceutical    Corporation
ViroPharma,    Inc.
Genomma    Lab    Internacional
Tsumura    &    Co.
Vivus,    Inc.    United
Divi's    Laboratories    Ltd.
Nippon    Kayaku    Company
Huadong    Medicine    Co.,
Beijing    SL    Pharmaceutical
Gansu    Yasheng    Industrial
BTG    plc    United
Guilin    Jiqi    Pharmaceutical
Zhejiang    Medicine    Co.,
STADA    Arzneimittel    AG
Pharmacyclics,    Inc.
Sawai    Pharmaceutical    Co.,
Shenzhen    Salubris    Pharmaceuticals
S&P    Pharmaceutical    Co
Piramal    Healthcare    Limited
Glenmark    Pharmaceuticals    Ltd
Theravance,    Inc.
Tieling    Newcity    Investment
Zhangzhou    Pientzehuang    Pharmaceutical
Taro    Pharmaceutical    Industries
Human    Genome    Sciences,
Recordati    S.p.A.
Impax    Laboratories    Inc.
Wuhan    Humanwell    Healthcare
Financiere    de    Tubize
Chongqing    Zhifei    Biological
DiaSorin    S.p.A.
Beijing    Double-Crane    Pharmaceutical
Opko    Health    Inc.
Inner    Mongolia    Yili
Kyorin    Holdings    Inc
Ironwood    Pharmaceuticals    Inc.
China    Shineway    Pharmaceutical
Almirall    S.A.
Amarin    Corporation    plc
Adcock    Ingram    Holdings
Corporativo    Fragua,    S.A.
Rohto    Pharmaceutical    Co.,
Guangzhou    Pharmaceutical    Co
Mochida    Pharmaceutical    Co.,
Toho    Holdings    Co.,
Par    Pharmaceutical    Companies,
Halozyme    Therapeutics,    Inc.
Kaken    Pharmaceutical    Co.,
Tibet    Urban  Development
Virbac    SA
Jiangxi    Jiangzhong  Pharmaceutical
Tempo    Scan    Pacific,
Wockhardt    Ltd.
China    Medical    System
Guilin    Sanjin    Pharmaceutical
Scinopharm    Taiwan,    Ltd.
Shanghai    RAAS    Blood Products Co
BB    Biotech    AG
Sartorius    Stedim    Biotech
Akorn,    Inc.    United
Xizang    Haisco    Pharmaceutical
Guizhou    Bailing    Group
Kissei    Pharmaceutical    Co.,
Tibet    Cheezheng Tibet Medicine Co, Inc.
The Medicines    Company
AstraZeneca    Pharma
Zhejiang    Huahai    Pharmaceutical
Green    Cross    Corp
Jiangsu    Wuzhong    Industrial

Defense Dept awards $138.5 M to MediVector

2012-03-20T15:06:00.000-07:00

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The US military has awarded a $ 138.5 million dollar contract to a drug development company to develop a therapeutic for influenza.

The U.S. Department of Defense (DEFENSE THREAT REDUCATION AGENCY) awarded the contract to Mass-based MediVector, Inc ( http://medivector.com/).

The treatment is still in the experimental phase, but has shown effectiveness in tests on rodents.

MediVector in the news:

MILITARY-INDUSTRIAL COMPLEX IN ACTION: March 12, 2012 Defense Dept. Contracts

http://www.huntingtonnews.net/26126

Anti-flu drug trials for Tamiflu faked, effectiveness called into question

2012-01-20T13:51:00.000-08:00

Anti-flu drug effectiveness called into question, does not reduce hospital visits

An alarming report on the efficacy of the influenza treatment oseltamivir (Tamiflu) shows that a review of data concludes that drug manufacturer Roche failed to provide key data on the effectiveness of the treatment and adverse side effects.

The US CDC continues to tout the drug, even though evidence is mounting that the drug trials were fabricated. Further, evidence of sometimes severe adverse reactions were never documented.

http://www.medscape.com/viewarticle/757226
http://bit.ly/yYgjXw

January 20, 2012 — An international team of medical experts is calling into question the safety and efficacy of the anti-influenza drug oseltamivir (Tamiflu), saying that a review of unpublished data shows inconsistencies and that the drug's maker, Roche, has failed to provide access to a substantial amount of data on the drug. The review was published online January 18 in the Cochrane Library.
Governments around the world have spent billions of dollars stockpiling oseltamivir and zanamivir (Relenza, GlaxoSmithKline) — neuraminidase inhibitor drugs that were recommended by the World Health Organization in 2002 as treatment in the event of an influenza pandemic.
The integrity of the data on this class of drugs has continued to be a subject of debate, however. In a previous Cochrane review published in 2008, researchers documented significant concerns about publication bias in trials for the drugs. Importantly, they reported that as much as 60% of patient data from phase 3 treatment trials for oseltamivir had never been published.
The unpublished data included a study involving 1400 people of all ages, representing the largest treatment trial ever conducted on oseltamivir.
"We are concerned that these data remain unavailable for scrutiny by the scientific community," said Tom Jefferson, MD, a Cochrane review author of both the previous analysis and the new analysis, and an independent epidemiologist based in Rome, Italy, in a press statement.
In this week's update of the previous review, Dr. Jefferson and researchers in the United States, Great Britain, Japan, and Australia analyzed previously unpublished data from 25 studies, including 15 on oseltamivir and 10 on zanamivir. Data from an additional 42 studies could not be reviewed because of insufficient information or unresolved discrepancies in the data, the authors note.
The data included clinical study reports and regulatory documents that were available either through available sources or Freedom of Information requests. The studies mainly involved adults during influenza seasons in both hemispheres. All of the studies that were reviewed were sponsored by the drugs' makers.
"We reasoned that regulatory data could help contextualise trial data, providing deeper insight than clinical study reports alone," the authors write.
Symptoms Reduced, but Hospitalizations Unchanged
The research on oseltamivir showed that the drug did reduce the amount of time to alleviation of symptoms by an average of 21 hours (95% confidence interval, −29.5 to −12.9 hours; P < .001). However, it failed to reduce the number of people requiring hospital treatment (odds ratio, 0.95; 95% confidence interval, 0.57 - 1.61; P = .86).
In a postprotocol analysis of 8 studies, the authors found that participants randomly assigned to receive oseltamivir in treatment trials had a reduced odds of being diagnosed with influenza (odds ratio, 0.83; 95% confidence interval, 0.73 - 0.94; P = .003), which they say was likely the result of an altered antibody response. The zanamivir trials did not show the same trend.
Biased Reporting of Adverse Events
Important inconsistencies in the evidence of neuraminidase inhibitor adverse events were meanwhile observed between the unpublished and previously published studies. For instance, Japanese regulatory documents have shown higher nervous-system-related and psychiatric adverse events among patients receiving oseltamivir compared with placebo groups, yet there is no mention of those data in published reports.
In the 2 most cited published reports of serious adverse events, one has no mention of the adverse events, and the other "stated that '...there were no drug-related serious adverse events,' " the authors note.
"[W]e found no published paper of an oseltamivir trial which reported nervous or psychiatric adverse events, except headache," they write.
Adding further speculation to the published oseltamivir research is the fact that Roche, when pressed by the British Medical Journal after the earlier report, admitted that some published papers on its drug were ghost written.
In a statement to Medscape Medical News, Roche said it provided the Cochrane group with access to 3200 pages of "very detailed information, enabling their questions to be answered."
"Roche has made full clinical study data available to health authorities around the world for their review as part of the licensing process. It is the role of global health authorities to review detailed information on medicines when assessing benefit/risk," the company stated.
"All completed Roche sponsored clinical studies on the safety and efficacy of Tamiflu are available as peer-reviewed publications or in summary form on www.roche-trials.com. More detailed clinical trial reports are available for use by investigators on a password-protected site, enabling researchers to verify the findings of these studies and publications relating to them."
Although the Cochrane authors may dispute whether the information provided to them answered their questions, they are clearly in agreement on the role of global health authorities, and suggest that this is where the ball is being dropped.
CDC Still Endorses Oseltamivir
Despite the ghost-written papers and adverse event reporting inconsistencies, top governmental agencies, including the US Centers for Disease Control and Prevention (CDC), continue to endorse oseltamivir, Dr. Jefferson told Medscape Medical News.
"The US CDC and the European CDC continue to quote trials of Tamiflu which we now know were ghost written," Dr. Jefferson said.
"They keep citing the evidence regarding adverse events, although they are aware of our misgivings and the fact that 60% of the evidence in treatment trials is unavailable and never been seen outside of Roche and perhaps 1 or 2 regulators."
Journal Reports "Absurdity" of the Discrepancies
A separate investigation published online January 17 by the British Medical Journal to coincide with the Cochrane review indicates that oseltamivir data were subjected to different standards from different regulatory agencies around the world, resulting in further conflicting impressions of the drug's efficacy.
The European Medicines Agency (EMA), for instance, provided only a portion of clinical study reports on oseltamivir drug trials to Cochrane, despite the fact that the agency was legally permitted to request the full reports from the manufacturer.
The EMA has since informed the British Medical Journal of its intentions to publish reports for all drugs submitted for approval in upcoming years.
In a press statement, Fiona Godlee, MD, editor-in-chief of the British Medical Journal, said the findings underscore the need for a more consistent approach to drug regulation when the global community is concerned.
"The discrepancies between the conclusions reached by different regulators around the world highlights the absurd situation we find ourselves in," she said.
"In a globalised world, regulators should cooperate and pool their limited resources. Otherwise we will continue to waste money and risk people's health on drugs that don't work."
Impending Influenza Epidemic Sped Up Drug Approval Process
Dr. Jefferson noted that the threat of a global pandemic and pressing need for a newer drug treatment likely played a big role in putting the review of neuraminidase inhibitors in the fast lane.
"In the documents we reviewed, the clear reason why the first drug of the neuraminidase inhibitor family, Relenza, was approved was they hadn't registered a new anti-influenza drug since 1988," Dr. Jefferson said. "It was now 1999, there was an impending threat of an influenza pandemic, and they thought they needed to move the field along and register this new drug."
The urgency should not justify the continued support of a drug when important questions are raised, however, suggested Peter Doshi, PhD, from Johns Hopkins University, Baltimore, Maryland, who is a coauthor of the review.
"For governments to support a manufacturer's claim without their own independent verification is dangerous," said Dr. Doshi.
"In an emergency, of course standards of evidence can change, but the clinical trials on Tamiflu were conducted over a decade ago, yet there is no indication that CDC and the Department of Health and Human Services, which support many of the manufacturer's claims, have done their own independent verification of the complete trial evidence."
Tim Uyeki, MD, a medical officer and epidemiologist from the CDC's Influenza Division, told Medscape Medical News that the agency cannot comment on unpublished data; however, he explained that the CDC's recommendations, based on guidance from the Advisory Committee on Immunization Practices, carefully consider the risks and benefits of a drug in the context of its public health need.
"The guidance for use of antivirals for influenza treatment in the US is based on a review of published data, including results of randomized controlled trials, observational studies, and consideration of groups at higher risk for influenza complications. There are some inherent limitations of observational studies, given that they are not controlled; however, they can be very informative," he said.
"There are abundant observational studies for hospitalized patients with seasonal influenza and from the 2009 H1N1 pandemic, and all of these suggest clinical benefit of antiviral treatment, particularly if the drugs are initiated early."
Dr. Uyeki added that the current lack of other treatments for influenza is indeed an important issue.
"One has to look at the evidence for benefits and what are available options," he said. "We don't have many other options right now for the treatment of influenza. We certainly need more antiviral drugs — drugs that work in different mechanisms of action — and other therapeutic approaches, such as combination antiviral therapy."
"Vaccination is the best way to prevent influenza, but it won't prevent all illness from influenza."
Seasonal influenza epidemics are associated with an estimated average of more than 200,000 hospitalizations per year in the United States, and a range of from about 3400 to 49,000 influenza-associated deaths per year, Dr. Uyeki said.
All Research Should Be Accessible, Regardless of Commercial Interests
The Cochrane report researchers said they supported the use of the drugs in serious or compassionate cases, but they called on regulators around the world to be more consistent in their approach to the accessibility of research results.
"The mechanism of action of oseltamivir should be independently researched, with special regard to any direct central action of the drug Tamiflu, until a clear picture of its effects on influenza complications, transmission and action on antibodies can be clarified," they write.
"We all, as taxpayers, have a stake in this drug," Dr. Jefferson said to Medscape Medical News. "No other drug that I can think of is being stockpiled in the US."
"We cannot tolerate a situation where unnamed people make decisions on drugs that effect all of us."
The study received funding from the National Institute for Health Research Health Technology Assessment Program in the United Kingdom. Dr. Jefferson was an ad hoc consultant for F. Hoffman-La Roche Ltd from 1998 to 1999. He receives royalties from his books published by Blackwell and Il Pensiero Scientifico Editore, none of which are on neuraminidase inhibitors. He is occasionally interviewed by market research companies for anonymous interviews about phase 1 or 2 products unrelated to neuraminidase inhibitors. Dr. Doshi has disclosed no relevant financial relationships.

ECDC continues to advise no flu shots for children

2011-12-02T14:32:00.000-08:00

The European Centre for Disease Control and Prevention continues to advise against the vaccination of children for the prevention of seasonal influenza.

The "Factsheet for the general public on seasonal influenza" notes that few "EU countries recommend immunising children or offering vaccines to pregnant women. An expert panel convened by ECDC considered there was as yet insufficient evidence on the burden of infection in children to take any view for or against immunisation."

http://ecdc.europa.eu/en/healthtopics/seasonal_influenza/basic_facts/Pages/factsheet_general_public.aspx

Preventing Killer Flu: Endothelial cells may be factor in preventing cytokine storm

2011-09-15T11:15:00.000-07:00

A team from the Scripps Research Institute found that endothelial cells may act as a regulator in how the body reacts to the flu virus.

The scientists were looking at the S1P pathway (molecular control circuit) and gave rodents a substance to stimulate the S1P1 receptor. They learned that the treatment lessened severe cytokine response.

Details available on SCIENCE NOW:
http://news.sciencemag.org/sciencenow/2011/09/surprising-cells-rein-in-killer-.html

Thousands get flu in Australia, but few require medical care.

2011-07-20T08:25:00.000-07:00

Thousands get the flu in Australia, but few require medical care.

Influenza monitoring systems are reporting nearly 8,000 cases, early in the Australia flu season.

Recent flooding and bad weather may be to blame, but it is not clear that this is either the main or sole reason for the high reported numbers. One theory is that there is simply more testing going on, another that fewer people are being vaccinated due to concerns about the safety of the flu shot.

Report in Brisbane Times: http://www.brisbanetimes.com.au/national/warnings-as-flu-cases-surge-20110719-1hn5m.html#ixzz1SeuevxIe

Report on “The Conversation”: http://theconversation.edu.au/flu-is-on-the-rise-australia-and-thats-not-to-be-sniffed-at-2414

Reuters reports potential tripling of flu vaccine production by 2015

2011-07-19T08:30:00.000-07:00

Reuters is reporting that the World Health Organization (WHO) has announced 11 new producers of flu vaccine. The manufacturers could potentially provide up to 1.7 billion doses of season flu vaccine by 2015.

According to Marie-Paule Kieny, WHO assistant director-general, "what we are continuing to do is to make sure that not only will there be more pandemic vaccine if need be, but also that the sites where these vaccines will be produced will be more diverse geographically and more populations of the world will have earlier access to pandemic vaccine."

"We have to take influenza vaccine as a tool to combat influenza pandemic, not just a tool to maximise profit," said Dr. Pathom Sawanpanyalert, Thailand's chair of the WHO's Global Action Plan for Influenza Vaccines, the experts group that met. (Reporting by Stephanie Nebehay)

http://www.reuters.com/article/2011/07/14/health-flu-vaccine-idUSLDE76D0XD20110714

CDC offers Zombie Apocalypse preparedness plan

2011-05-19T14:28:00.000-07:00

If you previously took everything the CDC said with a grain of salt, their latest pronouncement is not likely to change your mind.

A tongue-in-cheek blog post describes what to do in case zombies strike.

http://emergency.cdc.gov/socialmedia/zombies_blog.asp

Excerpt:

"Zombie Apocalypse

There are all kinds of emergencies out there that we can prepare for. Take a zombie apocalypse for example. That’s right, I said z-o-m-b-i-e a-p-o-c-a-l-y-p-s-e. You may laugh now, but when it happens you’ll be happy you read this, and hey, maybe you’ll even learn a thing or two about how to prepare for a real emergency.

A Brief History of Zombies
We’ve all seen at least one movie about flesh-eating zombies taking over (my personal favorite is Resident EvilExternal Web Site Icon.), but where do zombies come from and why do they love eating brains so much? The word zombie comes from Haitian and New Orleans voodoo origins. Although its meaning has changed slightly over the years, it refers to a human corpse mysteriously reanimated to serve the undead. Through ancient voodoo and folk-lore traditions, shows like the Walking Dead were born."

Full blog post is here:

http://emergency.cdc.gov/socialmedia/zombies_blog.asp

FDA refuses to approve Merck HPV treatment Gardasil for older women

2011-04-08T13:01:00.000-07:00

Merck (NYSE: MRK) announced that it's Gardasil HPV (Human Papillomavirus) treatment is not effective in women over the age of 26 (specifically, ages 27-45). Although it had applied to the FDA to extend treatment for use by this age group, approval was denied.

Sales of Gardasil have been declining, as the market for this drug has been saturated. Gardasil is approved for young women (and also young men, aged 9-26). This is the second time that the FDA has disallowed wider use of the vaccine.

The full text of Merck's announcement can be found here:
http://bit.ly/gmcAeg

Flu symptoms visits decrease for 6th straight week

2011-04-06T09:55:00.000-07:00

Doctor visits for influenza-like illness decreased for the sixth straight week, as problems associated with the flu continue to fall.

According to the CDC's (Centers for Disease Control and Prevention) weekly Fluview update, only one state in their survey showed an increase in flu symptoms (Idaho).

From the weekly report: "# Visits to doctors for influenza-like illness (ILI) nationally decreased again for the sixth consecutive week, falling below the national baseline for the first time since the week ending December 25, 2010. However two of 10 U.S regions—Regions 2 and 10—continue to report ILI activity at or above baseline levels. One state (Idaho) had high ILI activity."

The full report can be found here: http://www.cdc.gov/flu/weekly/summary.htm

FluCide drug candidate shows promise but the mouse gets it in the end. NanoViricides, Inc. (OTC BB: NNVC.OB)

2011-03-22T13:54:00.000-07:00

NanoViricides, Inc. (OTC BB: NNVC.OB) announced that a recent animal study of it's FluCide drug candidate, showed a quadrupling in efficacy over a previous study.

In the study, mice were aspirated with one million virus particles of the H1N1 flu virus. The mice were treated with both FluCide and Tamiflu 24 hours later. The results show that the mice treated with Tamiflu survived only 8.3 days, while the FluCide treated mice were able to hold on for 20.2 to 22.2 days.

The full announcement is here:
http://www.businesswire.com/news/home/20110321005653/en/NanoViricides-Reports-Treatment-FluCide-Drug-Candidate-Achieves

Group calls for removal of mercury from all vaccines

2011-03-11T06:46:00.000-08:00

In a press release Thursday, the Coalition for Mercury-Free Drugs (http://mercury-freedrugs.org/) points to new research that illustrates more reasons to avoid adding Thimerosal (THIM) to vaccines. Thimerosal is a mercury-based compound that is widely used as a preservative in flu vaccines.

Although some previous research on the relationship between mercury and autism has been widely discredited, a new paper, by Helen V. Ratajczak, "Theoretical aspects of autism: Causes—A review," published in the Journal of Immunotoxicology, provides fresh clues. While not "proving" a relationship, the paper points to some damning evidence:

1. "Not only is every major symptom of autism documented
in cases of mercury poisoning but also biological
abnormalities in autism are very similar to the side effects of
mercury poisoning itself (Bernard et al., 2001)."

2. Mercury poisoning & Autism symptoms (in parallel): "...include psychiatric disturbances (e.g., impairments in sociality, stereotypic behaviors, depression, anxiety disorder, and neuroses), increased incidences of allergies and asthma, increases in the presence of IgG autoantibodies against brain and myelin basic proteins, reductions in natural killer cell function, and increases in neopterin levels (indicative of immune activation). Autistic brains show neurotransmitter irregularities that are virtually identical to those arising from mercury exposure, i.e., changes in serotonin and dopamine concentrations, elevated epinephrine and norepinephrine levels in the plasma and brain, elevated serum glutamate levels, and an acetylcholine deficiency in the hippocampus (Bernard
et al., 2001)."

3. "More evidence linking autism with mercury poisoning is the timing of inclusion of Thimerosal in vaccines in the 1930s closely preceding the discovery of autism in 1943."

4. Toxicity of Thimerosal: "There are dangerous effects of Thimerosal on the immune
system, particularly on T-lymphocytes. Mercury induces glutathione depletion, increased oxidative stress, and apoptosis in these cells (Makani et al., 2002). In addition, Thimerosal causes toxic effects on brain cells (Baskin et al., 2003), inhibits glutamate transport (Mutkus et al., 2005), affects nerve differentiation (Parran et al., 2005), induces immunoproliferation and formation of autoantibodies to fibrillin proteins (Havarinasab and Hultman, 2005), and depletes glutathione (James et al., 2005)."

The full press release is here:
http://www.prnewswire.com/news-releases/researchers-urge-the-removal-of-mercury-from-flu-shots-117737828.html

FDA & Justice Dept files consent decree against JNJ (NYSE: JNJ) division McNeil-PPC

2011-03-10T15:13:00.000-08:00

The FDA today announced that a consent decree of permanent injunction has been filed against Tylenol producer McNeil-PPC (division of JNJ), for failing to comply with good manufacturing practices.

The FDA will assume control of three plants; located in Puerto Rico, Fort Washington, PA and Lancaster, PA.

The FDA announcement can be found here:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246685.htm

Excerpt:

"Manufacturing deficiencies at McNeil’s facilities have resulted in several extensive recalls, including an April 30, 2010, recall of lots of several liquid products such as children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a Warning Letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.

The decree, filed by the U.S. Department of Justice’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, requires McNeil to destroy all drugs under McNeil’s control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil also must retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance.

If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually."