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AFD - Ethics (or lack thereof)

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  • AFD - Ethics (or lack thereof)

    A Bizarre And Disturbing Story Out Of Poland

    # 2119

    These sorts of things aren't supposed to happen.

    So far, there has been no direct link established between the vaccine trial, and the excess reported deaths, so the insinuation in the headline may be premature.

    Still . . . . if this clinic was conducting a clinical trial without full disclosure to the participants, and without following the rules for such studies, it is a very serious matter indeed.

    This also raises questions of oversight responsibility by the pharmaceutical company involved. Obviously we need a good deal more detail on this story to know exactly what happened.

    This from the UK's Telegraph.

    Homeless people die after bid flu vaccine trial in Poland

    By Matthew Day in Warsaw
    Last Updated: 5:19PM 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.

    posted by FLA_MEDIC @ 1:00 PM

  • #2
    Re: AFD - Ethics (or lack thereof)

    Google on the topic of Poland Bird flu and over a dozen stories showed up.

    Homeless Die In Poland Of Bird-Flu Vaccine
    by Staff
    Twenty-one homeless individuals in Poland have died after being given an unproven bird-flu virus vaccine, authorities have charged.

    Prosecutors have accused three doctors and six nurses of misleading the homeless individuals by telling them they were being given a new influenza vaccine rather than a vaccine for the H5N1 bird-flu virus, The Daily Telegraph said Thursday.
    Thought has a dual purpose in ethics: to affirm life, and to lead from ethical impulses to a rational course of action - Teaching Reverence for Life -Albert Schweitzer. JT


    • #3
      Re: AFD - Ethics (or lack thereof)

      independently of this special case, don't we have to loosen our conditions
      for vaccine trials and panflu research ?
      Last edited by Sally Furniss; July 5, 2008, 03:47 AM. Reason: typo
      I'm interested in expert panflu damage estimates
      my current links: ILI-charts:


      • #4
        Re: AFD - Ethics (or lack thereof)

        FluTrackers thread on this issue:


        • #5
          Re: AFD - Ethics (or lack thereof)

          Pandemic Ethics Summit

          # 2146

          A severe pandemic would place enormous demands on our finite health care resources. With not enough to go around, difficult choices will have to be made.

          Who gets a scarce vaccine? What about ventilators? Or hospital beds? What are the ethical obligations of Health Care Workers? What about their Employers?
          IUPUI (Indiana University-Purdue University Indianapolis) held a two-day ethics summit this week to discuss these, and other ethical questions that will surely come up in a pandemic.

          This story from the And a hat tip to Kobie on the Wiki for posting it.

          Follow the link for the whole article.

          Deciding who gets the vaccine first

          IUPUI hosts summit on ethical issues of pandemic diseases

          By Shari Rudavsky

          Posted: July 16, 2008

          A disease pandemic doesn't have to exist to have a discussion about ethical dilemmas that could come with it, including:

          How should limited, potentially life-saving resources like vaccines or ventilators be allocated? Do those who are sickest or those who are hardiest have first dibs when such resources are limited?

          What recourses do employees have if they want to stay home on the advice of the local health department but against employers' wishes?

          How should hospitals handle employees who refuse to come to work?

          These and myriad other questions were on the agenda this week at the first-ever summit on ethical questions a pandemic might pose.

          Held on the campus of Indiana University-Purdue University Indianapolis, it brought together public health officials from 35 states and territories.

          It "was to be a summit of the United States who could speak to and with each other about the common challenges they face and in particular the common ethical challenges," said Eric Meslin, director of the Indiana University Center for Bioethics, which co-hosted the event.

          For many participants, the two-day conference, which concluded Tuesday, offered an opportunity to share what works best and grapple with thorny issues with others in the field.

          (Continue reading . . . )
          posted by FLA_MEDIC @ 9:19 AM


          • #6
            Re: AFD - Ethics (or lack thereof)

            I'm interested in expert panflu damage estimates
            my current links: ILI-charts:


            • #7
              Re: AFD - Ethics (or lack thereof)

              HHS Releases Vaccine Allocation Guidelines

              # 2169

              Today the HHS released their updated Pandemic Vaccine Allocation guidelines.

              Here is their press release, and a little later this afternoon I'll have an overview of these new guidelines.

              HHS Announces Guidance on Pandemic Vaccination Prioritization

              The U.S. Department of Health and Human Services (HHS) released today its guidance on allocating and targeting pandemic influenza vaccine. The guidance provides a planning framework to help state, tribal, local and community leaders ensure that vaccine allocation and use will reduce the impact of a pandemic on health and minimize its disruption to society and the economy.

              ?This guidance is the result of a deliberative democratic process,? HHS Secretary Mike Leavitt said. ?All interested parties took part in the dialogue; we are confident that this document represents the best of shared responsibility and decision-making.?

              As part of developing the guidance, HHS held day-long public engagement and stakeholder meetings throughout the country and received more than 200 written public comments on the goals and objectives of pandemic vaccination. In all the meetings, stakeholders and the public identified the same four vaccination program objectives as the most important:
              • Protect persons critical to the pandemic response and who provide care for persons with pandemic illness,
              • Protect persons who provide essential community services,
              • Protect persons who are at high risk of infection because of their occupation, and
              • Protect children.

              The guidance is also firmly rooted in the most up-to-date scientific information available and directly considers the values of our society and the ethical issues involved in planning a phased approach to pandemic vaccination.

              The ultimate goal of the pandemic vaccination program is to vaccinate every person in the United States who wants to be vaccinated. Because pandemic vaccine cannot be made fast enough for everyone to be vaccinated at once, Federal, state, local and tribal governments, communities, and the private sector can use the guidance to decide who should be vaccinated during this early stage to best protect people and communities.

              This targeted vaccination structure defines target groups in four broad categories that relate to pandemic vaccination objectives ? to protect people who 1) maintain homeland and national security, 2) provide health care and community support services, 3) maintain critical infrastructure and 4) are in the general population.

              Everyone in the United States is included in at least one vaccination target group. People who are not included in any occupational group would be vaccinated as part of the general population based on their age and health status.

              While vaccines are an important resource in a pandemic, vaccination will only be one of several tools to fight the spread of influenza when a pandemic emerges. Other tools include community public health measures, antiviral medications, face masks and respirators, washing hands and covering coughs and sneezes.

              For further information, please see
              posted by FLA_MEDIC @ 1:38 PM


              • #8
                Re: AFD - Ethics (or lack thereof)

                FluTrackers thread on the USA Vaccine Guidance Document:


                • #9
                  Re: AFD - Ethics (or lack thereof)

                  HHS Guidance on Allocating And Targeting Pandemic Influenza Vaccine

                  # 2170

                  Today we have the long-awaited release of the HHS's (Dept. Health and Human Services) guidance on pandemic vaccine allocation called Guidance on Allocating and Targeting Pandemic Influenza Vaccine.

                  The release of this guidance document was coordinated with a teleconference held by the HHS, with Dr. William Raub, Dr. Bruce Gellin, Dr Ben Schwartz, and Dr. Jon Krohmer making brief presentations.

                  As Dr. William Raub pointed out, a targeted pandemic vaccine won't begin rolling off the production lines for 20 weeks, and then, only in limited quantities.

                  And Dr. Bruce Gellin made it clear that while there are great hopes for faster vaccine production techniques in the future, plans must be made based on our current capacity.

                  For now, the availability of a strain specific vaccine for a pandemic will be extremely limited during the first six months, and possibly longer, into a pandemic crisis.

                  Anytime you have to prioritize who will receive a potentially life-saving vaccine first - and who will have to wait - there will controversy. No plan is likely to please everyone.

                  Still, I have to say I generally agree with the decisions arrived at in this guidance document. I also recognize how tough making these decisions had to have been.

                  Below is a chart showing the 5 tiers, and if the supply of vaccine is extremely scarce, the priority within each tier (running top to bottom).

                  (click to enlarge)

                  There are variations to these tiers at different pandemic levels (Cat 1-5).

                  The one's listed here assume a CAT 4 or CAT 5 pandemic. Tier 1 priorities remain the same at all pandemic intensities, but adjustments may be made to lower tiers depending on the virulence of a pandemic.

                  Tier 1

                  As you can see, tier 1 consists of those people who are crucial to maintaining our safety and infrastructure, along with pregnant women (very high risk, based on the 1918 pandemic) and toddlers.

                  Tier 2

                  Tier 2 encompasses critical occupations and High Risk populations.

                  Tier 3

                  Less critical occupations are included in tier 3, along with healthy children.

                  Tier 4

                  The elderly are positioned ahead of the general population, but after children and critical infrastructure and health care workers.

                  Tier 5

                  The last tier are healthy adults not involved in critical infrastructure or health care.

                  The entire guidance document is well worth downloading and reviewing. While a major step forward, this document is just part of the job ahead. Here is how the guidance document puts it.

                  Next Steps and What States and Communities Can Do

                  This guidance is the result of careful and rigorous consideration of scientific data, historical analyses, ethical issues, and comments from government agencies, key stakeholders at the national, State, and local/community levels, and members of the general public.

                  The development of vaccine prioritization guidance, however, is only one step toward planning and implementing an effective pandemic vaccination program. Strategies for how persons in occupationally defined target groups should be identified and how their priority can be verified at the time of vaccination must be developed.

                  State, local, and tribal planners also must plan for allocation and distribution of vaccine to sites where it will be administered, vaccination clinic procedures, and programs to monitor coverage and potential adverse events. Strategies and materials also must be developed for employers and the public to clearly communicate the vaccine targeting strategy and support it?s implementation.

                  I'll certainly have more on this subject in the future. For now, though, I have to agree that putting health care workers, and critical infrastructure and national security personnel at the head of the line makes sense to me.

                  I imagine there will be some discussion over the relative placement of various essential workers, particularly in the lower tiers. My first thought, looking at the list, was that transportation ought to be higher than tier 3. Supply chain problems are likely to cause cascade effects throughout the economy, and could endanger our ability to maintain our critical infrastructures.

                  That question was raised by Robert Roos of CIDRAP, and briefly addressed during the tele-conference.

                  It was stated that demands on transportation will probably decrease during a pandemic, and that the transportation system has fungibility- some measure of redundancy built in. It was also suggested that truckers were unlikely to be at increased risk of occupational exposure.


                  I'm certain there is no perfect solution here. Compromises have to be made, and it is the nature of the beast that no one comes away totally pleased with the result.

                  And quite honestly, no one will know if the right decisions were made about this, or anything else, until after the next pandemic arrives.

                  Last edited 7/23 3:40 EDT

                  posted by FLA_MEDIC @ 2:03 PM


                  • #10
                    Re: AFD - Ethics (or lack thereof)

                    and if people try to buy their vaccine OTC ?

                    seize it ? imprison buyer and seller ?

                    control all incoming vaccine by customs and prevent
                    that some American citizen who is not in an appropriate "tier"
                    gets it ?

                    Glaxo's prepandemic vaccine is approved in Europe.
                    But they won't sell it to privates. Is it ethical ?

                    Now, where is the country which allows selling of prepandemic
                    vaccine to privates ?

                    US-citizens could buy and pay it now, but have it stored
                    in the foreign country. Once panflu starts, the laws may be changed
                    so US-citizens could get access to their vaccines ?!?
                    I'm interested in expert panflu damage estimates
                    my current links: ILI-charts:


                    • #11
                      Re: AFD - Ethics (or lack thereof)

                      Some people remember the mess left by DES, the Birth defects and other problems this and other drugs have caused.

                      I agree that during a pandemic their will probably be many who would be desperate and willing to take a vaccine that may not be approved by authorities. We must remember that, that same authority has to balance the responsibility to protect the public from potentially harmful drugs with delivering drugs to protect the public in a timely fashion. This and deciding who should or should not get the vaccine in a pandemic are awesome responsibilities and I for one would not want to carry this burden.
                      We were put on this earth to help and take care of one another.


                      • #12
                        Re: AFD - Ethics (or lack thereof)

                        One of the bigger problem with modern health policy around the world is the concept of ''utility'', an old-fashioned marginalist-derived vision of the ''value'' of everything.

                        If one does connect the health status of an individual with his/her ''utility'' to system's continuity, then the same individual may be considered with low marginal utility or high marginal utility according his/her age / education skill / job / health conditions / life-expectancy and more other economics-linked variables.

                        In brief, for every year gained in life-expectancy for this individual the marginal utility will drive the choice to include or not in a defined health policy: if the year gained increases the marginal utility he/she will be included; in the other case, he/she will be excluded.

                        It is clearly the result of the transition from ''rights'' (always in power with the benefit and obligations always expendable by individuals) to ''utility'' (or with a polite term, compassionate welfare), where the individual may be excluded by benefit within the will of the authorities.

                        Rights are universal / utility is a mere evaluation of a politician.

                        Perhaps the most striking expample of this theory was - in the past decade - the calling for a tender of a east european country for the installation of a new welfare system. The tender was won by a western tobacco multi-billionaire corporation...


                        • #13
                          Re: AFD - Ethics (or lack thereof)

                          Posts #12, 11, 10, ...
                          depicted well the (un)ethic situation.

                          Especialy the gsgs questions point actualy can have a "yes" answers instead of ?.

                          But the main failure is that it can be added one more question:
                          - why be constricted to doing vacc. triages, when an matched vaccine can be produced only 4-6 months after the pandemic starts - when it already passed first time?

                          - the planers rely on ready stocks
                          But they can be only pre-pandemics triages, because would not maching;

                          In that case exists enaugh time to produce them for all, without triages.

                          - or rely on new (not reclamed now) technology of vacc., capable of creating vacc. in a real time (at the first signs of an pandemic) to vaccinate in a few weeks.

                          In that case, with such speady vacc. production, it must be possible to product bilions of doses in a few weeks, and all population can receive it without triages of people who would not get it - it can be triaged the primary first distribution target, but without leaving the rest of citizens without.


                          • #14
                            Re: AFD - Ethics (or lack thereof)

                            Thursday, July 31, 2008

                            <!-- Begin .post -->
                            A Tale Of Two Scenarios

                            # 2194

                            Earlier this week I highlighted a video of an ethics seminar held by by the Minnesota Department of Health and the University of Minnesota Center for Public Health Preparedness.

                            Here is a link to that presentation.

                            Contained in the first video was a slide graphically illustrating each state's planning assumptions about the type of pandemic they are preparing for.

                            As you will see, there is a wide divergence of opinion.

                            Roughly 20% of our states are preparing for a severe 1918-style pandemic, while 20% are preparing for a moderate (some might even say `mild') event.

                            For the remaining 60% of our states, the severity level they are preparing for is ambiguous.

                            States in White are planning for a moderate pandemic, orange colored states are planning for a severe pandemic, and the plans for gold colored states are ambiguous on this point.

                            This graphic also appears in the powerpoint presentation by Dorothy Vawter, PhD. entitled Age-Based Rationing in a severe Pandemic. This chart is current as of Sept.2007.
                            I'm aware that Michigan has recently released an addendum to their pandemic plan, and that may move them into the ambiguous column.

                            While no one can know what the next pandemic will bring, the U.S. federal government has adopted the attitude that it is prudent to prepare for a severe 1918-style pandemic.

                            The HHS defines a severe pandemic as:
                              • An attack rate of 30% (90 million Americans sickened)
                              • 50% (45 million) requiring outpatient medical care
                              • 11% (9.9 million) requiring hospitalization
                              • 745,000 requiring mechanical ventilation
                              • 1.9 million deaths (2.1% fatality ratio)

                            A moderate (1958/68-like) pandemic is described as follows:
                              • An attack rate of 30% (90 million Americans sickened)
                              • 50% (45 million) requiring outpatient medical care
                              • .9% (865,000) requiring hospitalization
                              • 64,875 requiring mechanical ventilation
                              • 209,200 deaths (.23% fatality ratio)

                            In other words, while the number of people affected doesn't change, a severe pandemic is envisioned to be about 10 times worse than a moderate one.

                            A quick check of some of these state's pandemic plans reveals that the definition of a `moderate pandemic' varies greatly. We'll look at two states (Georgia & South Carolina), and compare their assumptions with the Federal guidance for a pandemic event.

                            Georgia, with a population of roughly 9.3 million people, assumes the following:

                            Most noticeable here is the estimated attack rate of less than 15% (half of the Federal estimate for a moderate pandemic).

                            Since the rest of their numbers are based on a percentage of the number made ill by a pandemic virus, those numbers are proportionately lower as well.

                            South Carolina, with 4.3 million residents, acknowledges an attack rate of up to 35%, but their case fatality ratio is a little more than 1/3rd of 1%.

                            The upshot of all of this is that if we see a severe pandemic, tens of millions of Americans will reside in states that only prepared for a moderate event.

                            South Carolina, which is only expecting a maximum of 16,800 flu-related hospitalizations could, under the federal scenario, find that 150,000 of their residents could need hospital care. And instead of 5,000 deaths, they could be looking at 28,000 flu-related fatalities.

                            Similarly, Georgia could find that instead of 1.14 million people clinically ill, that they must deal with nearly 3 million. Instead of 22,000 requiring hospitalization, they may find the demand is closer to 300,000. And the number of deaths could exceed 58,000 - not the 6200 assumed in their plans.

                            The Federal assumptions are guidelines, and states are free to use their own judgement in deciding what kind of crisis to prepare for. If we see a mild pandemic, then I suppose those states that prepared for a moderate event will feel pretty good about themselves.

                            But if the next pandemic is like 1918, or worse . . . then states that prepared for a moderate pandemic are likely to find their plans inadequate for the task at hand.

                            And if that happens, then there are going to be a lot of state and local officials with some explaining to do.

                            posted by FLA_MEDIC @ 9:20 AM