Tuesday, December 4, 2012

CDC Flu Scare Campaign Off To An Early Start

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?
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. 

Wednesday, October 10, 2012

Risk benefit assessments needed for H5N1 Bird Flu research

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.

Friday, October 5, 2012

Swine flu rears its ugly little head under the radar.

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. 

Thursday, October 4, 2012

CDC report shows flu virtually nonexistent in the US

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. 

Tuesday, March 20, 2012

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

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
Eli Lilly   
Teva Pharmaceutical Industries
Gilead    Sciences,Inc.
Takeda Pharmaceutical Company
Celgene    Corporation
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
Watson Pharmaceuticals,    Inc.
Taisho Pharmaceutical Holdings
Merck KGaA
Ono Pharmaceutical Co
Aspen Pharmacare Holdings
Kyowa Hakko Kirin
Grifols    S.A.   
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

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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

Friday, January 20, 2012

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

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.


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.