Health workers on trial for vaccine scam in Poland

[sharon sanders]

Homeless people die after bid flu vaccine trial in Poland

By Matthew Day in Warsaw
Last Updated: 4:37PM 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.

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.

http://www.telegraph.co.uk/news/worldnews/europe/poland/2235676/Homeless-people-die-after-bid-flu-vaccine-trial-in-Poland.html

[mixin]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

In 2002, a number of ambulance medics were found guilty of killing their patients for commissions from funeral companies.

A new low that leaves me almost speechless.

[sharon sanders]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

This news brings to the forefront all kinds of ethical issues. In a pre-pandemic and pandemic situation we will see both the worst and the best in humanity.

[Gert van der Hoek]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

machinetranslated

Ten people died

Wednesday, 2 July 2008 03:09

Vaccine for avian flu are tested for the homeless


ASSOCIATED PRESS / Luis Romero for each new specyfikiem vaccinating against the flu with the homeless Grudziądza dostawali from surgery after 5-10 gold. They did not know, however, that it did not mean to ordinary influenza, unlike siejącą destruction in the world with avian influenza. Ten people died. Are their death was linked to tests? The shocking information has reached a reporter for "Fact Finding" TVN. The behavior of doctors condemned the minister of health Ewa Kopacz.

Homelessness argue that they do not know that their szczepią against avian influenza. In April 2007 grudziądzka clinic "good practice" to send them your query, which was provided free of charge for the transmission of the vaccine against ordinary flu called VAXIGRIP. For every vaccine they had to get the money, so some zaszczepili even a dozen times. Only now it appears that they received two doses of vaccine FLUAD-H5N1, which has been assessed in this study a vaccine against the dangerous H5N1 influenza virus.

Shortly after the vaccination more than a dozen people died. It is not known whether the test vaccine was the cause of death for the homeless.

Many of them are people schorowane and wycieńczone lifestyle for which such experiments can be dangerous. Statistics, however, gives much thought.

"In 2004, four homeless people died from our centre" - admits in an interview with "Faktami" Mieczyslaw Wacławski, head of St. shelters them. Albert in Grudziądz Brother. However, in the years 2005 and 2006 a total of 16 people died, in 2007 - the year in which they tested the vaccine - as many as 21 According to TVN24, victims may be even 350 people. About 150 of them - are homeless. The rest are ordinary citizens, zwabieni zarobkiem.

The management of GP weapons is that all patients signed consent to the vaccination and knew, against which the szczepią.

Yesterday I received a court to Torun indictment against three doctors and six nurses. As investigations showed, they broke, they not only patients but also the pharmaceutical company, which instructed the vaccination.

Prosecutor alleges the forgery of documentation, urging witnesses to make false confessions and certifying Defamation, as well as misappropriation of property. The allegation of endangering the health and life of the homeless but the indictment did not act in November.

Zachowaniem doctors oburzona is the minister of health. "The doctors who conducted these tests should not return to the occupation" - as doctors assessed the accused in the programme "Facts after Faktach" Ewa Kopacz. "In the interest of all doctors is that those who zawinili, suffered a penalty" - she added.

http://www.dziennik.pl/wydarzenia/article201579/Szczepionke_na_ptasia_grype_testowali_na_bezdomnych.html

[Oracle]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

What exactly does 'testing a bird flu vaccine' entail?

Simple vaccination, right? Then how do you test to see if it works, in human tests? You challenge them with a titered dose of H5N1 virus.

===

So the test cadre are the poor/homeless - the very lowest rungs of the economic ladder. In a nation that has twice the TB rate of the rest of Europe

http://www.newsrx.com/newsletters/TB-and-Outbreaks-Week/2000-08-15/2000081533322TW.html

in 2000 (31.5 per 1000), although it's making progress in detection and early treatment (dropping to 26.6 per 1000 in 2003 and to 25 in 2006).

http://www.ncbi.nlm.nih.gov/pubmed/16190542 In 2003, about 40% of total mortality was from infectious diseases. The burden of infectious disease patients are uneducated, and of low social and economic class.

Poland has real problems with it's public health care system

(insider view of Polands Public Health care system - http://beatroot.blogspot.com/2008/01...s-kiss-of.html)

Poland has also had one of the highest smoking rates in the world (rank 4 in 1985), but that has declined, mostly due to a 1990s economic crunch in the Post-Soviet age and return to productivity and consumerism of the late-90s, to something closer to the global 'smoker norm' (~30%), although the poor are still overly represented among tobacco consumers.

While the economy improved dramatically between 2001 and 2007 (unemployment and inflation dropped by half), and Poland managed to pay off many of its outstanding international aide debts, its present government has inherited an unhealthy (pardon the pun) public service administration. Health care providers make a very poor wage.

So, it's not really surprising to hear that the Polish homeless suffered unusually high mortality rate, in clinical trials of a new H5N1 vaccine.

With near-absent public health care for the poor, high TB- and infectious disease rates, and abysmal diet - and probably rampant alcoholism and drug use - this social class is Very Likely to be an exceptionally risky cohort for vaccine testing.

[Blue]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

Hopefully, they were not also mentally ill as so many homeless people are.
I would be concerned about their ability to give informed consent for any kind of testing.

[Giuseppe]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

Poland Charges Doctors for Misleading Patients in Drug Test

By Marta Waldoch

July 3 (Bloomberg) --

Poland's regional prosecutor's office charged three doctors and six nurses for misleading volunteers in a drug test by not telling them the vaccine they were testing was against avian influenza and not regular flu.

More than 300 people, including a number of homeless, took part in the trials, which were approved by medical authorities and the country's health minister, prosecutor Agnieszka Reniecka said in an interview today.

All the procedures were followed, except getting the patient's ``conscious agreement'' for the test, the Grudziadz, northern Poland-based prosecutors' office said in a statement yesterday.

Gazeta Pomorska and Polish private television channel TVN24 yesterday reported as many as 21 people might have died in relation to the tests.

They cited Mieczyslaw Waclawski, an executive in a homeless shelter in Grudziadz, who connected the deaths of 21 of his tenants last year with the bird flu vaccine trial.

Although six people who'd been in the tests died, there was no evidence the deaths were linked to the study, Reniecka said.

To contact the reporter on this story: Marta Waldoch in Warsaw on mwaldoch@bloomberg.net
Last Updated: July 3, 2008 10:32 EDT
-

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aQJJtu577eZA

------

[Sally Furniss]

Re: 3 Doctors & 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

<table border="0" cellpadding="0" cellspacing="0" width="100%"><tbody><tr><td width="92%">Homeless people die after bird flu vaccine trial in Poland
04-JUL-2008 Intellasia | The Telegraph
Jul 4, 2008 - 7:00:00 AM
</td> <td class="smallbody" align="right" valign="top" width="8%">

</td> </tr> </tbody></table> 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.

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 UK pound 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.

http://www.intellasia.net/news/articles/health/111246112.shtml

[tropical]

Re: 3 Doctors &amp; 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

Very serious problem.
I'm glad to see that the investigation part of Poland society works, when the other lacked.

Poland is part of EU. Hopefully that is not an tendency to relax human trials procedures, but only a case of outlawed behaviour of some "humans".
Not adequately (with the person acknowledge) informing what are the real health risks when applying a vaccine in a non-pandemic time, and to persons with knowed health vital risks if assumed, is criminal indeed.

Also, this case must raise concerns about the here (FT thread, Dr. N.) suggested policy of current (not at the pandemic starts) application of human pre-pandemic vaccines in the now bf endemic regions.

The worst:
#4 Dutchy
"Only now it appears that they received two doses of vaccine FLUAD-H5N1, which has been assessed in this study a vaccine against the dangerous H5N1 influenza virus.
Shortly after the vaccination more than a dozen people died. It is not known whether the test vaccine was the cause of death for the homeless."

FLUAD for seasonal flu is already be legaly administered in the 2006/07 ordinary flu season onto the elderly population.
It contains an diferent adjuvant (squalene based) that was used into the experimental H5N1 vaccine at the time also.

If that's the case in this FLUAD-H5N1 vaccine, the problem is (where?):
- in the adjuvant - that would mean similar deaths occured when administered as a seasonal vaccine
- in the strain - that means non-resolved issues about that part of the vaccine
- in the "guinea humans" because of their illnesses - but flu vaccines must target the elderly population with chronic, and debilitating illnesses also.

The above seems to point out that the actual technology, or the actual vaccines postulates, don't meet enaugh security of health to be administered "en mass" without an actual state of pandemic.

We need more new approaches for schieldings, without the actual painfully and deadly (for all recipients, animals and humans) "try-err-try-...-success" procedures.
Something that can give inovative vacc. results bypassing this 100 years (or a milenium) old try-err method.
New Nobel's needed ...

[Gert van der Hoek]

Re: 3 Doctors &amp; 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

Update "Clinical Trials", July 3, 2008:


Locations


Poland
Centrum Badań Farmakologii Klinicznej monipol
Krak&#243;w, Poland, 30-969

http://clinicaltrials.gov/ct2/show/locn/NCT00434733

Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

This study has been completed.


Criteria

Inclusion Criteria:

Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

Receipt of another investigational agent within 4 weeks

Receipt of influenza vaccination for current season 2006/2007.

Any acute disease or infection, history of neurological symptoms or signs,

Known or suspected impairment of immune function, any serious disease, bleeding diathesis

Fever (defined as axillary temperature &#179;38.0&#176;C) within 3 days (prior to Visit 1)

Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control

Surgery planned during the study period

Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine

Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination

History of (or current) drug or alcohol abuse

Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

ClinicalTrials.gov processed this record on July 03, 2008

http://clinicaltrials.gov/ct2/show/NCT00434733

[tropical]

Re: 3 Doctors &amp; 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

Hi Dutchy,

that's only what are wroted on the study paper ...

Why than the setup of an investigation with criminal activity investigated persons?

<TABLE class=tborder style="BORDER-TOP-WIDTH: 0px" cellSpacing=1 cellPadding=6 width="100&#37;" align=center border=0><TBODY><TR><TD class=thead colSpan=2>07-02-2008 11:10 PM</TD></TR><TR title="Post 166896" vAlign=top><TD class=alt1 align=middle width=125>Dutchy</TD><TD class=alt2>machinetranslated

Ten people died

Wednesday, 2 July 2008 03:09

Vaccine for avian flu are tested for the homeless
</TD></TR></TBODY></TABLE></B>


Of course if the initialy published above text are based on lies and counterf. facts and all players are "candid", than the question and the consequences, for this kind of vacc. quality/trials change in other directions than the previously wroted remarks ...

[Gert van der Hoek]

Re: 3 Doctors &amp; 6 Nurses Investigated for Improper Human Testing of Bird Flu Vaccine

Yes Tropical,

Novartis - the sponsor of the trial - could have a problem here. We will
have to wait and see.

[Giuseppe]

France 24 | Health workers on trial for vaccine scam in Poland.

France 24 | Health workers on trial for vaccine scam in Poland.

Health workers on trial for vaccine scam in Poland

Nine health workers went on trial in northern Poland Monday accused of having tested a vaccine against bird flu on nearly 200 patients without their knowledge, court officials said.


The accused -- three doctors and six nurses -- are charged with "fraud, creating false documents and delivering health care without authorisation" to 196 patients, judge Piotr Szadkowski of the Torun region told AFP.

If found guilty, they risk up to 10 years in jail.

All nine accused, some reportedly clad in wigs and sun glasses to avoid being identified, pleaded not guilty.

The medical personnel are charged with administering a vaccine banned in Poland against the deadly H5N1 strain of bird flu that can be transmitted to humans.

The patients were paid for the vaccines, Polish news agency PAP reported.

They allegedly led their patients, many of them poor and homeless, to believe they were being vaccinated against ordinary flu.

Police discovered the scam by chance when they were called to break up a fight at a homeless shelter, PAP said.
-

<cite cite="http://www.france24.com/en/20090406-health-workers-trial-vaccine-scam-poland">France 24 | Health workers on trial for vaccine scam in Poland | France 24</cite>

[Treyfish]

Re: Health workers on trial for vaccine scam in Poland

Show romanizationShow romanization<object type="application/x-shockwave-flash" data="http://www.gstatic.com/translate/sound_player.swf" id="tts_object" height="18" width="18">



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Tests for the homeless

Is also not known whether the recent years will be launched in Torun District Court issue a sentence in the entire country celebrated the homeless testing vaccines against H5N1 influenza. It is in the 8 defendants and 350 victims, who in 2007 took part in the tests.

The case came to light when one of the proteges of local homeless shelters quarrel about money which they get to the clinic for vaccination. Called to allocate the police adventurers interested in the case of vaccination, for which the clinic pays for patients. As established, the homeless took part in clinical testing of vaccine against H5N1 avian influenza virus. After administration of subsequent doses, clinic patients, paid small amounts by way of lump-sum cost of travel to the vaccine. Chance to earn money for the homeless led some to conceal their real data, and several times to undergo vaccination.

Recall that in the dock of the court sat Torun doctors and nurses from one private clinic grudziądzkich. Having been allegations perform medical treatments without the consent of patients, the certification of untruth in the documents and dispose of property of the Sponsor unfavorable clinical trial.

http://www.nowosci.com.pl/look/nowos...0244&IdTag=238