Lancet: David Fedson On Statins For Pandemic Influenza

 

Photo Credit CDC PHIL

# 6307

 

Dr. David Fedson – former Professor of Medicine at the University of Virginia School of Medicine and formerly Director of Medical Affairs, Aventis Pasteur MSD - has long championed the idea that we should be looking at statins for pandemic flu, which he believes may help modulate the immune response.

 

If they can be proved effective, statins have the advantage of being cheap, easy to manufacture and distribute, and have relatively few side effects.

 

A couple of earlier papers from Dr. Fedson include:

 

Pandemic Influenza: A Potential Role for Statins in Treatment and Prophylaxis

David S. Fedson

New Approaches to Confronting an Imminent Influenza Pandemic

Dr. Fedson and Peter Dunnill, DSc,FREng

 

 

The big `if’ in all of this is just how beneficial statins really are for pandemic influenza, and while we’ve a number of encouraging studies, not all have shown positive results.

A quick roundup includes:

 

Statin drugs lower respiratory death risk: study

Tue Apr 10, 2007 12:40pm EDT

By Maggie Fox, Health and Science Editor

 

A study presented in October of 2009 at the annual meeting of the IDSA, the Infectious Diseases Society of America, in Philadelphia suggested that statins cut the mortality rate for seasonal flu by 50%.

 

Maryn McKenna writing for CIDRAP brought us the details.

 

Statins may help patients with severe seasonal flu

Maryn McKenna Contributing Writer

Oct 29, 2009 (CIDRAP News) – Commonly available drugs that are sold in lower-cost generic versions improve the survival of patients hospitalized for seasonal influenza, researchers reported today, raising the possibility of a widely available treatment that could be used in a severe flu pandemic if other drugs are in short supply.

 

Again in 2011, a study by the London School of Hygiene and Tropical Medicine published in the BMJ –looked at 6 month post-pneumonia survival rates among those taking statins, and those not taking these medications.

 

While there may have been other factors at work - survival rates were considerably higher (87% vs 80%) among those already taking statins when they fell ill  (see Statins & Pneumonia: Revisited).

 

But not all of the studies have been positive.

 

In July of 2009 there was a report that found no evidence of benefit among pneumonia patients (see Another Take On Statins And Pneumonia) taking statins.

 

 

So while not all of these studies are in agreement, many of them have supported the notion that statins may be of considerable value during a pandemic, and may contribute to the survival rate of patients with pneumonia.

 

Which brings us to a short op-ed piece in The Lancet today, where Dr. Fedson and Steven M. Opal write on what they see as the practical response to the H5N1 transmission study controversy.

 

 

The Lancet Infectious Diseases, Volume 12, Issue 5, Pages 364 - 365, May 2012

doi:10.1016/S1473-3099(12)70079-8

Research into transmissibility of influenza A H5N1: a practical response to the controversy

David S Fedson , Steven M Opal

 

Access to this article requires free registration.

 

The authors maintain that the real issue is not whether or not the controversial H5N1 studies should be published, but rather, why influenza scientists and their sponsors have not undertaken serious research into the efficacy and effectiveness of immunomodulatory agents (like statins) in treating pandemic flu.

 

Unfortunately, the answer to that question may simply boil down to the fact that since many statins are off-patent - and can sold generically for pennies a pill - there is little financial incentive for the pharmaceutical industry to invest a lot of money into laboratory and clinical research.

Assuming the real priority is saving lives during a pandemic, what is needed is government sponsorship of appropriate research, or a private support by a non-profit organization with deep pockets.

 

For more on statins, and their potential role in pandemic influenza, you may wish to revisit:

 

Study: Statins, Influenza, & Mortality

Another Study On Statins And Pneumonia

Dr. David Fedson: The Case For Using Statins In A Pandemic

First Statins, Now Fibrates

Statins Revisited

Statins & Pneumonia: Revisited

 

# 5465

 

 

The idea certainly isn’t new.  

 

If fact, I mentioned it in this blog as far back as 2006, and have written about it extensively probably a dozen times since then.  

 

While unproven, and not without controversy, over the years we’ve seen several studies suggesting that taking statins - cholesterol reducing drugs - can improve survival rates among those with influenza and/or pneumonia.

 

Dr. David Fedson – former Professor of Medicine at the University of Virginia School of Medicine and formerly Director of Medical Affairs, Aventis Pasteur MSD - has long championed the idea that we should be looking at statins for pandemic flu, which he believes may help modulate the immune response.

 

A couple of his papers on the subject include:

 

Pandemic Influenza: A Potential Role for Statins in Treatment and Prophylaxis

David S. Fedson^a

 

New Approaches to Confronting an Imminent Influenza Pandemic

Dr. Fedson and Peter Dunnill, DSc,FREng

 

 

In 2007 we saw a study that seemed to support the idea, one that indicated that statins lowered the mortality rate of people with pneumonia.

 

 

Statin drugs lower respiratory death risk: study

Tue Apr 10, 2007 12:40pm EDT

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - People who use statin drugs are less likely to die of influenza and chronic bronchitis, according to a study that shows yet another unexpected benefit of the cholesterol-lowering medications.

 

And in 2008 this encouraging report made the headlines:

 

Statins may cut pneumonia death, blood clot risks

27 Oct 2008 20:00:13 GMT

Source: Reuters

By Will Dunham

WASHINGTON, Oct 27 (Reuters) - Cholesterol-fighting drugs known as statins reduced the risk of dying from pneumonia or developing dangerous blood clots in the legs, adding to a growing list of benefits from the popular drugs, two research groups said on Monday.

 

 

But not all of the studies have been positive.

 

In July of 2009 there was a report that found no evidence of benefit among pneumonia patients (see Another Take On Statins And Pneumonia) taking statins.

 

 

But another study, presented in October of 2009 at the annual meeting of the IDSA, the Infectious Diseases Society of America, in Philadelphia suggested the opposite - that statins cut the mortality rate for seasonal flu by 50%.

 

Maryn McKenna writing for CIDRAP brought us the details.

 

Statins may help patients with severe seasonal flu

Maryn McKenna Contributing Writer

Oct 29, 2009 (CIDRAP News) – Commonly available drugs that are sold in lower-cost generic versions improve the survival of patients hospitalized for seasonal influenza, researchers reported today, raising the possibility of a widely available treatment that could be used in a severe flu pandemic if other drugs are in short supply.

 

 

So while not all of these studies are in agreement, many of them have supported the notion that statins may be of considerable value during a pandemic, and may contribute to the survival rate of patients with pneumonia.

 

 

Today we’ve another study – this time by the London School of Hygiene and Tropical Medicine published in the BMJ – that looks at 6 month post-pneumonia survival rates among those taking statins, and those not taking these medications.

 

While there may be other factors at work here – and more research is needed - survival rates were considerably higher (87% vs 80%) among those already taking statins when they fell ill.

 

As of this posting, the study has not appeared on the BMJ website.  I assume it will shortly. 

 

Here are excerpts from the LSHTM press release:

 

 

Pneumonia death rate lower among people who take statins

Tuesday, 5 April 2011

LSHTM study finds evidence for protective effect of cholesterol-lowering medication

 

Taking statins could help prevent people dying from pneumonia, according to a study by the London School of Hygiene and Tropical Medicine.

 

The researchers found that the risk of death in the six month period after diagnosis of pneumonia was substantially lower among those who were already receiving the cholesterol-lowering drugs compared with those who were not.

 

Previous studies have suggested that statins may be associated with a more favourable outcome after bacterial infection.

 

This study, published online in the BMJ today, supports a possible protective effect of statins against mortality in patients with pneumonia.

 

But the researchers point out that as they looked at patients who were already taking the medication when they developed pneumonia, a randomised clinical trial is needed to determine whether starting a statin at the time of diagnosis has a similar effect.

(CONTINUE  . . . . )

Notes to Editors:

Title of study online at BMJ: “Effect of statin treatment on short term mortality after pneumonia episode: cohort study” by Ian Douglas, Stephen Evans and Liam Smeeth.

 

 

The $64 question is whether administering statins after a pneumonia diagnosis provides any protective benefits.  There are reasons to believe that it might, but further studies are needed to prove or disprove it.

 

If you’d like to learn more about Dr. David Fedson and some of his ideas on statins, there are three 1-hour radio interviews available from 2009 that were conducted by Sharon Sanders of FluTrackers. 

 

You’ll find them archived at the FluTrackers links below.

 

David Fedson 06 April 2009

http://www.flutrackers.com/forum/aud...pril062009.mp3

David Fedson 18 May 2009

http://www.flutrackers.com/forum/aud...May18.2009.mp3

David Fedson 02 November 2009

http://www.flutrackers.com/forum/aud...Nov02.2009.mp3

Dr. David Fedson: The Case For Using Statins In A Pandemic

 

 

# 4750

 

 

During a major influenza pandemic, millions of people could fall desperately ill during the first few months.  Pharmaceutical interventions – like vaccines – take months to produce and distribute, and antivirals are in short supply as well. 

 

What the world really needs is a cheap (preferably generic) medication that will help treat severe influenza cases.

 

Ideally it would be a shelf stable pill, one that is easy to dispense, has a low incidence of side effects, and can reduce influenza morbidity and mortality.

 

A tall order.    But perhaps not impossible to fill.

 

At least, that’s the hope of a number of scientists who are looking into whether statins, or corticosteroids (or a combination of the two), might prove effective in reducing some of the most serious flu symptoms.

 

Dr. David Fedson has long championed the idea that we should be investigating statins and other cheaper drugs that may help modulate the immune response.

 

Fedson is a former Professor of Medicine at the University of Virginia School of Medicine and was formerly Director of Medical Affairs, Aventis Pasteur MSD.

 

 

A couple of his papers on the subject include:

 

Pandemic Influenza: A Potential Role for Statins in Treatment and Prophylaxis

David S. Fedson^a

 

New Approaches to Confronting an Imminent Influenza Pandemic

Dr. Fedson and Peter Dunnill, DSc,FREng

 

In 2007 we saw a study that seemed to support the idea, one that indicated that statins lowered the mortality rate of people with pneumonia.

 

Statin drugs lower respiratory death risk: study

Tue Apr 10, 2007 12:40pm EDT

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - People who use statin drugs are less likely to die of influenza and chronic bronchitis, according to a study that shows yet another unexpected benefit of the cholesterol-lowering medications.

 

And in 2008 this encouraging report made the headlines:

 

Statins may cut pneumonia death, blood clot risks

27 Oct 2008 20:00:13 GMT

Source: Reuters

By Will Dunham

WASHINGTON, Oct 27 (Reuters) - Cholesterol-fighting drugs known as statins reduced the risk of dying from pneumonia or developing dangerous blood clots in the legs, adding to a growing list of benefits from the popular drugs, two research groups said on Monday.

 

Of course, not all of the studies have been positive.

  

Last July there was a report that found no evidence of benefit among pneumonia patients (see Another Take On Statins And Pneumonia) taking statins.

 

But another study, presented in October of last year at the annual meeting of the IDSA, the Infectious Diseases Society of America, in Philadelphia suggested the opposite - that statins cut the mortality rate for seasonal flu by 50%.

 

Maryn McKenna writing for CIDRAP brought us the details.

 

Statins may help patients with severe seasonal flu

Maryn McKenna Contributing Writer

Oct 29, 2009 (CIDRAP News) – Commonly available drugs that are sold in lower-cost generic versions improve the survival of patients hospitalized for seasonal influenza, researchers reported today, raising the possibility of a widely available treatment that could be used in a severe flu pandemic if other drugs are in short supply.

 

So while not all of these studies are in alignment, many of them do support the idea that statins may be of considerable value during a pandemic.

 

Which brings us to a guest editorial posted today on the Center For Biosecurity’s Clinicians’ Biosecurity Network website.  

 

I’ve just reproduced the opening paragraph.  By all means, you’ll want to follow the link to read it in its entirety.

 

An Alternative Approach to Pandemic Influenza That Clinicians Everywhere Could Use

By David S. Fedson, MD, July 23, 2010

The initial waves of the first influenza pandemic of the 21st Century have passed. Despite the best efforts of influenza scientists, health officials, and companies, more than 90% of the world’s people did not have timely access to affordable supplies of vaccines and antiviral agents. Instead, they had to rely on 19th Century public health “technologies.” They should have (and probably could have) had something better.^1-5

(Continue . . . )

The Vaccine Distribution Logjam

 

 

# 4213

 

 

A recurring theme in this blog has been that it isn’t enough to have sufficient vaccine manufacturing capacity – you have to have an infrastructure in place to deliver it to the world’s population.

 

And while most developed countries have systems in place that can, to some degree at least, deliver a vaccine to the public -  the same can’t be said for a great many developing nations.   

 

Even something as rudimentary (in the developed world) as keeping vaccines refrigerated can become a tremendous challenge in many regions of the world.  

 

The push to donate vaccines to the World Health Organization for distribution to poorer nations began early last summer, just after the virus was isolated. 

 

And many of you probably remember the hoopla last fall when millions of doses were pledged to the WHO  for distribution to poorer nations (see  WHO: Deploying Donated Vaccine As Soon As November.

 

This overly optimistic BBC story is from early October

 

Poorer nations get swine flu jabs

About 100 developing nations will begin receiving donations of the vaccine against swine flu as early as November, the World Health Organization says.

 

Millions of doses of the vaccine against H1N1 are being donated by pharmaceutical companies.

 

Fast forward four months and so far, only two nations have actually received the H1N1 vaccine: Azerbaijan and Mongolia.   

 

But it is not for the lack of trying, as you will see in this report from Donald G. McNeil of the New York Times.   

 

It is a terrific article, so follow the link to read it in its entirety.

 

 

 

Progress Is Slow on Moving Surplus Swine Flu Vaccine to Countries That Need It

• By DONALD G. McNEIL Jr.

Published: February 1, 2010

There is now so much unused swine flu vaccine in the world that rich nations, including the United States, are trying to get rid of their surpluses. But the world’s poorest countries — a few still facing the brunt of the pandemic — are receiving very little of it.

 

Of the 95 countries that told the World Health Organization last year that they had no means of getting flu vaccine, only two, Azerbaijan and Mongolia, have received any so far. Afghanistan is expected to be next.

 

Early last month, W.H.O. officials said they hoped to have shipped vaccine to 14 countries by now, and even then it would have been only enough to protect 2 percent of the countries’ populations.

 

While the flu has waned in North America, it is still affecting North Africa, Central Asia and parts of Eastern Europe. This imbalance between rich and poor countries, and the inefficiency of global vaccine transfers, frustrate many experts.

 

“If we’d been confronted with H5N1, we’d be completely caught with our pants down,” Dr. David S. Fedson, a former medical director for Aventis-Pasteur vaccines and an expert on pandemics, said, referring to the avian flu, which has a 60 percent mortality rate. “I don’t think any nation got it right.”

 

But the W.H.O. is stuck with the world as it is: countries that can afford vaccines save themselves first and, when the worst has passed, transfer their leftovers to the poor, using the W.H.O. as a clearinghouse.

 

That transfer “turns out to be an incredibly difficult logistical action,” said Dr. Keiji Fukuda, the W.H.O.’s chief of pandemic influenza. “It’s a mammoth effort by an awful lot of people and organizations and countries but holy moly, it’s a very complex operation.”

 

(Continue . . .  )

 

 

Over the years we’ve seen highly optimistic assessments of how much vaccine could be produced in the face of an H5N1 pandemic, but very little is said about the logistics of delivering it to the arms of the world.

 

Roughly a year ago – before novel H1N1 had made its appearance – the WHO stated they believed our global pandemic vaccine capacity was at least 2.5 billion doses a year.

 

At the time I wrote a bleak assessment of the prospects of actually delivering those billions of doses of H5N1 vaccine during the first year of a bird flu pandemic (see Study: Global Bird Flu Production Capacity).

 

The take away lesson here is the world needs to do a far better job with developing and maintaining its public health infrastructure.  Particularly in developing countries.

 

The blind eye that many richer nations have turned towards these third world deficits (and the ambivalence demonstrated by the rulers of many of these countries) - in this age of rising emerging infectious diseases - is a literal powder keg, waiting for a spark to set it off.

 

While one would hope that humanitarian reasons would be sufficient to spur action, the truth is a virulent epidemic outbreak in a place like Zimbabwe or Cambodia could be on our doorstep in a matter of days or weeks.

 

And that is something that no nation, rich or poor, is currently prepared to deal with.

Investigating Statins And Steroids For Flu

 

 

# 3978

 

During a major influenza pandemic, a billion people . . .perhaps more, could fall seriously ill over the course of a few months. 

 

Vaccines take months to produce, and our production and distribution capacity is woefully inadequate for a planet of nearly 7 billion people.  

 

Antivirals are in short supply as well, and very expensive to boot.

 

What the world desperately needs is a cheap (preferably generic) medication that will help treat severe influenza cases.  It needs to be a shelf stable pill, that is easy to dispense, has a low incidence of side effects, and can reduce influenza morbidity and mortality.

 

A tall order.    But perhaps not impossible to fill.

At least, that’s the hope of a number of scientists who are looking into whether statins, or corticosteroids (or a combination of the two), might prove effective in reducing some of the most serious flu symptoms.

 

This is a subject we’ve covered many times before, most recently about two weeks ago in Statins Revisited.   The Reveres at Effect Measure have discussed this often as well, with their most recent essay being  Statins for influenza. Why don't we know if it works yet?.

 

 

Dr. David Fedson has long championed the idea that we should be investigating statins and other cheaper drugs that may modulate the immune response. Fedson is a former Professor of Medicine at the University of Virginia School of Medicine and was formerly Director of Medical Affairs, Aventis Pasteur MSD.

 

Fedson is the author of a number of journal articles, and in recent years has devoted a great deal of attention to how we can meet the challenge of a global pandemic.

 

Last March Fedson was interviewed on FluTrackers  by Sharon Sanders in the wake of the publication of his latest article in the CDC’s Journal of Emerging Infectious Disease, entitled Meeting the Challenge of Influenza Pandemic Preparedness in Developing Countries.

 

An overview of his work, including the recent FluTrackers Interview may be viewed on the following two blogs:

 

Fedson On Meeting The Challenge Of A Pandemic

FluTrackers Interview With Dr. David Fedson

 

Over night, Helen Branswell of The Canadian Press published a terrific article on new studies that intend to investigate these drugs to see if they could help save lives in this pandemic.

 

As with any Branswell article, it is absolutely worth your time to follow the link and read it in its entirety.

 

Can cheap drugs help save H1N1 patients? Studies aim to find out

By Helen Branswell Medical Reporter (CP) – 15 hours ago

TORONTO — Can cheap and readily available treatments like steroids and cholesterol-lowering statin drugs help save the sickest of H1N1 patients? New efforts by researchers in Canada, the United States and France could help answer this pressing question.

 

Randomized controlled studies looking at whether corticosteroids, statins or a combination of the two could contribute to improved survival rates in gravely ill pandemic flu patients are being organized in the three countries by linked networks of intensive care specialists, according to Dr. John Marshall, chair of the Canadian Critical Care Trials Group.

 

The aim is to try to gather data fast enough to answer the questions in real time, a goal that eluded researchers during SARS.

 

Toronto physicians treating SARS cases tried to mount a clinical trial to see whether the antiviral drug ribavirin - which was routinely given to SARS patients for lack of other options - was actually helping. But before the trial could be approved, the disease disappeared.

 

The same could happen with this effort, admits Marshall, a trauma surgeon and critical-care specialist at Toronto's St. Michael's Hospital, who says it will take quick work and international collaborations to generate enough data to clarify the role steroids and statins might play in treating H1N1 cases.

 

(Continue . . . )

 

 

        *         *         *         *         *        *          *         *

 

If you’d like to learn more about Dr. David Fedson, there are a couple of 1-hour radio interviews – conducted by Sharon Sanders of FluTrackers – archived on the Radio Sandy Springs website. 

11/02/09 Guest Dr. David Fedson

05/18/09 Guest Dr. David Fedson.

Dr. David Fedson Radio Interview Today

 

 

# 3933

 

 

Later today Dr. David Fedson will be interviewed on Radio Sandy Springs by Sharon Sanders of Flutrackers.

 

The show will air at 4pm EST, on Atlanta's 1620 AM, and will be simulcast on the Internet on Radio Sandy Springs.

 

If you are unable to listen at 4pm, the show is generally repeated at 6pm, and is archived for downloading within a couple of days.  Dr. Fedson’s was interviewed in May by Sharon, and that show may be listened to at 05/18/09 Guest Dr. David Fedson.

Fedson is a former Professor of Medicine at the University of Virginia School of Medicine and was formerly Director of Medical Affairs, Aventis Pasteur MSD.

 

Fedson is the author of a number of journal articles, and in recent years has devoted a great deal of attention to how we can meet the challenge of a global pandemic.

 

Last March Fedson was interviewed on FluTrackers by Sharon Sanders in the wake of the publication of his latest article in the CDC’s Journal of Emerging Infectious Disease, entitled Meeting the Challenge of Influenza Pandemic Preparedness in Developing Countries.

 

An overview of his work, including the recent FluTrackers Interview may be viewed on the following two blogs:

 

Fedson On Meeting The Challenge Of A Pandemic

FluTrackers Interview With Dr. David Fedson

 

One of the subjects sure to come up will be the potential of using statins – cholesterol lowering drugs – in the treatment of influenza.  An idea that Dr. Fedson has encouraged more research in for years.

I wrote about this subject on Friday in Statins Revisited as did Revere at Effect Measure in Statins for influenza. Why don't we know if it works yet?.

 

      *       *       *      *      *      *      *      *      *      *      *

 

Radio Sandy Springs 1620 AM, is a low-powered Atlanta based talk radio station that simulcasts on the Internet.   An archive of recent Infectious Disease Hour shows may be accessed here.

This ought to be an interesting hour, so make plans to listen, or to download the archive when it gets posted next week.