Using the homeless as vaccine test subjects in Poland

The homeless in Poland may have more hazards than the elements to deal with—it seems some unethical scientists viewed them as easy pickings for tests. Oh, and don’t take any ambulance rides there, either.

I figure this story deserves passing along in its entirety because it’s short, and it’s weird enough on its own without any commentary from me. I added the italics.

Homeless people die after bird flu vaccine trial in Poland

By Matthew Day in Warsaw
Last updated: 11:17 PM BST 02/07/2008

Three Polish doctors and six nurses are facing criminal prosecution after a number of homeless people died following medical trials for a vaccine to the H5N1 bird-flu virus.

21 people died after being given the vaccine

The medical staff, from the northern town of Grudziadz, are being investigated over medical trials on as many as 350 homeless and poor people last year, which prosecutors say involved an untried vaccine to the highly-contagious virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

The director of a Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that last year, 21 people from his centre died, a figure well above the average of about eight.

Although authorities have yet to prove a direct link between the deaths and the activities of the medical staff, Poland’s health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession.

“It is in the interests of all doctors that those who are responsible for this are punished,” the minister added.

Investigators are also probing the possibility that the medical staff may have also have deceived the pharmaceutical companies that commissioned the trials.

The suspects said that the all those involved knew that the trial involved an anti-H5N1 drug and willingly participated.

The news of the investigation will come as another blow to the reputation of Poland’s beleaguered and poverty-stricken national health service. In 2002, a number of ambulance medics were found guilty of killing their patients for commissions from funeral companies.

Is it the magic flu bullet?

Acambis has licensed rights to a universal flu vaccine now in Phase I human trials. It is based on a protein that is consistent in all type A influenzas.

Universal flu vaccine

In the 1990s, VIB researchers connected to Ghent University, under the direction of Prof. Emeritus Walter Fiers, invented a universal flu vaccine. One protein on the surface of the influenza virus, the so-called M2 protein, remains unchanged in all human flu viruses known, including the strains that caused the pandemics in the last century. On the basis of the M2-protein they developed a vaccine and successfully tested it on mice and other laboratory animals: the M2 vaccine provided total protection against ‘A’ strains of flu, without side effects. Furthermore, this universal influenza vaccine is the first example of a vaccine inducing a protective immune response that normally does not occur in nature, for example following infection by a virus or a bacterium.

Clinical trials on humans

Acambis – a biotech company that specializes in the development of vaccines – has been exclusively licensed rights to VIB’s flu vaccine patent portfolio and has entered into a collaboration with VIB for further development work. At the moment, Phase I clinical trials on humans are underway – that is, the candidate vaccine is being administered to a small group of healthy people in order to verify the safety of the product and to provide an initial insight into the vaccine’s effect on the human immune system.

If it works… pandemic, schmandemic! Oh, and buy stock in Acambis.

Last day of US Gov’t pandemic flu blog

Today’s the last day of posting on the PandemicFlu.gov blog.

HHS’s stated goal on pandemic preparedness: “to help as many Americans as possible to understand that the threat of a pandemic influenza is real and to actively engage in personal preparedness.”

Well, have they achieved it? I’m pretty sure the people who’ve figured out that much at this point have done it on their own. But the blog did provide a brief opportunity for lots of people to express their desire for HHS to be a little more proactive in providing useful information through the means by which most people get their news, rather than just this series of tubes.

Bottom line: will an influenza pandemic happen? Yes, they’ve happened many times before and will again. Do we know which flu, or when? No, but a broad range of health professionals and policy makers are concerned that H5N1 is a strong candidate for creating disastrous global consequences if it turns out to be the one; it’s also a strong candidate for being the one, as it is spreading and mutating rapidly. Will the government and the health care system ensure your safety in the next flu pandemic? Unless the next pandemic happens after we’ve discovered a universal flu vaccine, probably not for the first few months at least. So why not do a little preparation, as the government is so quietly telling us to do? The fact is, you’re pretty much on your own if H5N1 “goes human” soon, and any preparation at all would also come in handy for all kinds of unforeseen, short term emergencies. It just makes sense.

For all of my posts on H5N1 click here.

Public largely unaware of flu officials’ real level of concern

“You’re going to be staying home for one year. There will be no school, there will be no work. All we’ll be doing is trying to keep ourselves alive.” – Richard Canas, Director, NJ State Office of Homeland Security and Preparedness

Once again I remind you to peruse the conversation that’ll continue for a little while longer over at the PandemicFlu.gov blog. Significant themes have been consistent throughout this conversation, about exactly what we as citizens should understand and do right now. Should we bet on the chance of a disastrous pandemic happening within the next couple of months…years…decades? Who should be advising us, and why don’t they seem to be doing that? When should they tell us to get ready for the worst, and where are the public service announcements? Are today’s concerned citizens just a bunch of alarmists and Monster Shouters or the foundation of a new kind of citizen’s corps that we will someday depend on more than we can imagine?

“Everything you say in advance of a pandemic seems alarmist. Anything you’ve done after it starts is inadequate.” – Michael Leavitt, HHS Secretary

Image: life as people knew it shut down during the 1918 pandemic.

There have been, up to now, two entirely separate national conversations focused on the potential H5N1 pandemic: one at the citizen level, and one at the government level. A primary theme from the PandemicFlu.gov blog has been from citizens who’ve educated themselves, demanding that the government widen its reach to communicate with citizens who aren’t researching bird flu on their own. They’re saying that it’s high time to discuss the risk and mitigating strategies down to the individual level with the nation, and the world. Those who’ve made an effort to educate themselves about H5N1 don’t feel that is an alarmist position.

We don’t know what the fatality will be but we can expect it to be very high. There will be enormous economic dislocation. Stock markets will close, international travel and trade will be limited. – Peter Cordingley, WHO

Image: 1918 flu patients at Camp Funston.

One recent post I’d point you toward discusses this issue and lessons learned from SARS: SARS and H5N1: The Precautionary Principle. Dr. Greg Dworkin points out that one of the significant findings of Canada’s SARS Commission concerned the “precautionary principle,” that is, action to reduce risk should not await scientific certainty. He quotes from the commission’s report,

Perhaps the most important lesson of SARS is the importance of the precautionary principle. SARS demonstrated over and over the importance of the principle that we cannot wait for scientific certainty before we take reasonable steps to reduce risk. This principle should be adopted as a guiding principle throughout Ontario’s health, public health and worker safety systems.

And arguably, it should be adopted by systems, governments, and individuals worldwide. How much caution is warranted, and should we even be concerned at the present time? Well, the quotes I’ve been sprinking throughout this post are supposed to give you an idea of just how worried national and world leaders are right now. The mainstream media carries this stuff, but sometimes you have to dig to find it; it comes and goes without causing a ripple as wars are fought and casualties are counted on the front page. The message from citizens to government leaders is: if you’re so concerned that you’re making statements like these at your meetings, your testimonies, and your invitation-only conferences, then why are you sitting around hoping the MSM will carry the message for you on its own? To which I don’t have an answer, either.

We’re dealing here with world survival issues—or the survival of the world as we know it. – David Nabarro, UN Senior System Coordinator for Avian and Human Influenza

Image: a ladies’ sewing circle in 1918.

I guess that’s enough Monster Shouting for today.  More at this previous post, or view all my posts on H5N1.

Monoclonal antibodies raise hopes for passive immunotherapy for H5N1

A paper in PloS Medicine has been the buzz this week, discussing favorable results seen against H5N1 in mice who were treated with human monoclonal antibodies generated from B cells of Vietnamese H5N1 survivors.

In the paper, titled Prophylactic and Therapeutic Efficacy of Human Monoclonal Antibodies against H5N1 Influenza, researchers from Switzerland, U.S., and Viet Nam created cell lines producing a total of 4 types of antibodies. Two of these antibodies were effective at neutralizing two different types (Clades I & II – see map for locations where these types have been found) of the HPAI H5N1 virus. The remaining two types of antibodies neutralized only Clade I virus. They tested one of each of these sets of antibodies in mice and found that used either prophylactically or therapeutically, they protected against H5N1 in a dose-dependent manner. The more antibody the mice got, the better they survived.

This is a modern twist on passive immunotherapy, which as you might recall, made the news last fall as a possible option for H5N1 therapy since records showed that in the 1918 flu, transfusions from flu survivors decreased mortality by 21% among sick recipients. However, on a large scale, that type of treatment isn’t considered feasible today, certainly not in a pandemic for a variety of reasons including the likely high number of patients needing treatment, relatively low availability of suitable donors, and lack of enough medical personnel to support such a time consuming effort.

If monoclonal antibodies can be produced in quantity, however, passive immunotherapy may again be thought of as a feasible treatment option in an H5N1 pandemic. If that happens, we’ll probably take whatever we can get.

Government must get flu prep message out

As I mentioned in this post a few days ago, the new HHS pandemic blog is full of comments “from the choir” on the need to prepare for the next pandemic, whether it’s a few months away or a few years. Yesterday’s post on the blog was answered again by a forceful command to the government: you’re not getting the message out—you’re leaving it up to the people to tell the people! Yet, the post did have resources to offer from the American Public Health Association, which is operating its own flu blog and a Get Ready site for pandemic flu (not much up there yet).

The government also has its web site, which does have a lot of good content, but most of the population is unaware of it and/or doesn’t access information that way. If HHS Secretary Leavitt wants people to prepare for an extended period of self-sufficiency in a health care crisis, he’s going to have to get on the tube and on the airwaves to tell people so.

I suspect HHS fears a panic if they start broadcasting. Just as our health care system is unready to respond to an H5N1 pandemic, HHS is unready to respond to widespread alarm in the population. But this can be avoided. That’s what marketing is all about, it’s not rocket science. Secretary Leavitt, people can be asked to take some responsible planning actions without freaking out. Trust people a little bit more now when we have the luxury of time to prepare. Recalling Katrina, we know what happens after the disaster when people are completely unprepared. Frankly, I never want to be that disgusted with my fellow Americans again. We now have to show that we learned from that, and communicate to people the importance of being individually ready before a pandemic hits.

Get prepped, folks. For myself, I’m thinking about adding “start fashion mask business” to my prepping to-do list.

UPDATE: Some of my previous posts include

H5N1: People urged to stock up on food

Senate hearing concludes U.S. not “scared enough” of bird flu

U.S. opens pandemic flu blog

Yesterday the Pandemicflu.gov site opened a temporary blog. I found the comments a lot more enlightening than the posts. There sure are lots of people out there wondering why the government is not giving a more urgent message to individuals on “prepping.” How to prep? Well, there’s the checklist for individual & family planning info on the site. It’s a little different from the one at Ready.gov for short-term emergencies (er, was Katrina a short-term emergency?).

For a pandemic, they’re saying be prepared for two weeks. You want to be on the safe side? Plan for a couple of months. Not that it would be typical for people to be stuck in their houses for two months but shortages of your favorite substances could occur; further, if someone in your home is sick and doing nauseating things like the guy in the pic, your whole family could be quarantined for longer than a couple of weeks.

And add booze to the prep list, which the government forgot for some reason. Even if you don’t drink it’ll be great barter after the end of civilization. Whee!

UPDATE: Here’s a comment from one of the posts on the flu blog. Many others seem to echo his sentiment. Does this guy live in a cave, or do you also feel like you’ve heard nothing in the news about the potential H5N1 pandemic? Does it seem to you like this global health threat has been kept “hush-hush?” Maybe it depends on where you get your news; if so, that’s a problem.

Jim W in Reno NV Says:

My sister in California has been telling me about the bird flu. She is very up on it and has suggested stockpiling suplies, masks, etc. Other than news from 2003 or 2004, this is the first I’ve heard of it.

Yesterday, I googled bird flu and found some info on it. It appears the the fed govt has given billions of dollars to the states for an upcoming epidemic.

Why hasn’t the news organizations said anything about this?!?

Why hasn’t the fed gov’t done some PSA’s on radio and television if this is so important?

I’m not sure what to think. The gov’t has plans for every state and local gov’t’s but no one seems to know what’s going on.

Please let me know if this is a big secret, and if not why does it seem it’s so “Hush, Hush”.

UPDATE: There seem to be a lot of new visitors today thanks to a link on Wired’s Danger Room!  Folks, have a look around and if there are topics you’re interested in hearing more about, just drop me a comment. Enjoy.

GSK adjuvant greatly increases H5N1 vaccine effectiveness

I’m back and just catching up.  A hopeless endeavor, I know.  Another bird flu vaccine story caught my eye this morning.  In a post last week I wrote about the FDA’s favorable outlook on the Sanofi-Aventis H5N1 vaccine, although its human trials showed sort of ho-hum results.  It’s better than nothing.

This week GlaxoSmithKline discussed its H5N1 vaccine at the IX International Symposium on Respiratory Viral Infections (ISRVI).  Claiming its proprietary adjuvant system enables its vaccine to elicit a high immune response with a small dose, GSK said its test on 400 volunteers showed 25x greater level of neutralizing antibodies with the adjuvant.  Further, it tested the vaccine in animals and found that the vaccine based on a Vietnam strain was effective against the Vietnam and an Indonesian strain of H5N1.

The animal test is interesting because we definitely want a vaccine that will hit multiple targets.  However, the Sanofi-Aventis vaccine also enabled human subjects to develop antibodies against more than one strain (Vietnam and Turkey).  So it sounds like where GSK really beats the competition is with its proprietary adjuvant, although the human tests did involve two injections 3 weeks apart.  Still, the amount of vaccine used can be very small when you have an adjuvant that greatly increases the response.  GSK used about half of Sanofi-Aventis’ smallest tested antigen dose in its tests.

GSK press release here (not sure how long this will be a “featured story” on the home page so you may have to search for it later), and SciAm news story here.

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