[HN Gopher] AstraZeneca exempt from coronavirus vaccine liabilit...
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AstraZeneca exempt from coronavirus vaccine liability claims in
most countries
Author : ColanR
Score : 22 points
Date : 2020-08-01 21:14 UTC (1 hours ago)
(HTM) web link (uk.reuters.com)
(TXT) w3m dump (uk.reuters.com)
| simonblack wrote:
| That raises a huge red flag in my mind over its safety.
|
| Big pharmaceutical companies have a history of marketing drugs
| that aren't quite as good or harmless as they are made out to be.
| toast0 wrote:
| This seems inline with at least US practices. Most (many?)
| vaccines are covered by the National Vaccine Injury
| Compensation Program, which shields the manufacturer from
| liability for covered injuries.
| foobarbazetc wrote:
| Not that it's relevant in this particular case, but I don't
| take anything that's only approved in the US, because the FDA
| really doesn't care, and especially doesn't care right now.
|
| Most drug companies actually view the US as the beta test
| country in a lot of ways.
|
| If something makes it to Australia (who are very strict on
| pharmaceuticals) then it's usually pretty safe.
| refurb wrote:
| As someone who has worked directly with the FDA, this is an
| absurd position. If anything, the FDA errs on the side of
| causing no harm versus getting a much needed treatment
| approved.
|
| And it might be good to know that most countries approve
| drugs based on the same data - global clinical trials.
| Australia is looking at the same data as the US when making
| an approval decision. Some countries require local trials
| (China and India, I believe).
|
| In addition, there is plenty of collaboration across drug
| approval bodies when developing or changing regulations. They
| are all talking to each other to determine the best approach.
|
| Here is a good example of the FDA and TGA (Australia) and
| Canada approving a new cancer drug together[1]
|
| [1] https://www.fdanews.com/articles/192766-fda-approves-
| first-c...
| m0zg wrote:
| That's the problem with a vaccine as compared to a therapeutic.
| You need to give it to a billion people for it to do any good.
| Some percentage of those people will have complications and
| die. If they fuck up with vaccine testing (which could cause
| the effect opposite of what the vaccine normally does, possibly
| weeks or _months_ after immunization), _millions_ could die,
| eclipsing the loss of life from the virus itself.
|
| Before someone attempts to read my mind: I, and everyone else
| in my family, am fully immunized, including some vaccines (e.g.
| BCG) not normally administered in the US. I also do the flu
| shot every year.
|
| But I do understand the risks a rushed vaccine could pose, and
| so I won't be taking it until at least 6 months after the
| initial wave of vaccination, and a careful study of population-
| scale safety and efficacy.
| deeg wrote:
| I'm not sure people understand the scale that vaccines work
| at. Right now--because we are close to wiping out polio--more
| people die every year from the polio vaccine than the actual
| disease. When you give billions of people a vaccine, even a
| one-in-a-million problem will still lead to thousands of
| deaths. It could be very hard to have wide-scale vaccines if
| we allowed people to sue for every death.
|
| (Just to be clear: I am very pro-vax. Get all recommended
| vaccinations.)
| creato wrote:
| I don't think the issue is that simple. For example, a Lyme
| disease vaccine was pulled from the market over dubious safety
| issues [1]:
|
| > This panel, described by one participant as raucous and
| riotous [35], provided a forum for all of the stakeholders
| [36]. In support of the vaccine, the FDA summarized the VAERS
| data and concluded that the evidence did not support a
| causative association. The vaccine manufacturer, now
| GlaxoSmithKline following a corporate merger, assured the
| assembled parties that the LYMErix(tm) vaccine did not cause
| harm to its recipients. They reviewed the status of their phase
| IV post-marketing surveillance. Practising physicians spoke of
| vaccine efficacy by describing the dramatic reduction in Lyme
| disease cases in their own practices.
|
| > Others raised concerns about the vaccine's safety. Scientists
| argued a potential role for genetic susceptibility and OspA-
| related autoimmunity in vaccine complications. Poignant
| presentations by several 'vaccine victims' described in detail
| their suffering. The prosecuting lawyers for the largest class
| action suit claimed that manufacturers suppressed reports of
| adverse events from the licensing trial and provided inadequate
| warnings to genetically susceptible individuals.
|
| > After hearing compelling testimonies from all the interested
| parties, the panel concluded the benefits of LYMErix(tm)
| continued to outweigh its risks. The panel made no changes to
| the product's labelling or indications. However, the FDA
| required the manufacturer to provide more vaccine safety and
| efficacy data by increasing the enrolment in their ongoing
| phase IV trial. The LYMErix(tm) vaccine remained available for
| public use.
|
| > Market withdrawal > Spawned by the press coverage of vaccine
| risks and the ongoing litigation, vaccine sales fell off
| dramatically in 2001. On 26 February 2002 GlaxoSmithKline
| decided to withdraw LYMErix(tm) from the market citing poor
| market performance [37].
|
| > On 9 July 2003 the pharmaceutical giant settled the class
| action suits with Sheller, Ludwig & Bailey as well as several
| other smaller law firms. The final agreement included over 1
| million dollars in legal fees for the prosecuting lawyers, but
| provided no financial compensation to the 'vaccine victims'.
| The plaintiffs' attorneys stated that the voluntary removal of
| LYMErix(tm) from the market accomplished the main goal of the
| suit. Despite the settlement, the manufacturer continued to
| deny that LYMErix(tm) caused harm and indicated that the
| decision to settle represented a choice based on economic
| concerns (i.e. the desire to avoid the costs of lengthy
| litigation) for a product showing relatively poor performance
| in the market.
|
| 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/
| open-source-ux wrote:
| _" That raises a huge red flag in my mind over its safety."_
|
| In this particular case, AstraZeneca are not doing the research
| for a COVID-19 vaccine. They have struck an agreement with the
| University of Oxford to manufacture and distribute the
| university's COVID-19 vaccine (still under development).
|
| https://www.ox.ac.uk/news/2020-04-30-landmark-partnership-an...
| mrgordon wrote:
| Well you can't have it both ways.
|
| 1. We want you to sell us the drug at cost with no profit
| margin
|
| 2. We want you to be responsible for unlimited liability for
| whatever the drug might eventually do
|
| Oh, and by the way, we want you to rush your testing so you
| don't have the normal time to verify its safety!
| PragmaticPulp wrote:
| In the United States, an existing law from 2005 likely already
| covers these cases anyway:
|
| > The United States, however, already has a law to exclude tort
| claims from products that help control a public-health crises in
| the form of the 2005 Public Readiness and Emergency Preparedness,
| or PREP Act.
|
| It's also important to note that AstraZeneca has also pledged to
| supply the doses with no profit:
|
| > AstraZeneca, Britain's second-largest drugmaker, has pledged to
| supply a total of more than 2 billion doses at no profit in
| agreements with the United States, Britain and European
| countries, among other nations and organisations.
|
| The exemption from liability claims is a function of the massive
| scale, the rushed timeline, and the lack of profit to defend
| claims in court.
|
| When you're supplying a vaccine at the scale of billions of
| people, it's inevitable that many people will convince themselves
| that the vaccine is the cause of unrelated medical issues. Even
| if the vaccine turns out to be just as benign as every other
| vaccine out there, having tens or hundreds of thousands of people
| attempt to sue these companies under the mistaken notion that the
| vaccine caused their problems could be extremely costly.
|
| The alternative would be a much more expensive vaccine (profit
| margins to buffer against potential losses) delivered much later
| (additional _years_ of safety testing and R &D).
| supernova87a wrote:
| I wonder if any stats or math go into this decision, and what the
| thresholds/limits of risk are? Or perhaps they're programmed into
| the criteria for what is accepted as the eventual vaccine.
|
| Because this decision is most definitely making a call about the
| value of saved lives / avoided sickness, versus the likelihood of
| unintentionally caused sickness due to vaccine side effects.
|
| I wonder what the acceptable numbers / risk percentages are.
| rubyn00bie wrote:
| I am okay with this... mostly because I don't think even
| someone/organization with the best intentions could possibly ship
| this without establishing this sort of clause up front.
|
| If anything, not doing so, would make me _more_ concerned because
| it seems like overconfidence, or refusing to acknowledge how long
| it normally takes to do clinical trials on something before
| releasing it the public.
|
| I know there are predatory pharmaceutical companies who would put
| their own profits way ahead of others... I just don't think in a
| global pandemic its going to be easy to intentionally lie about,
| or misrepresent, the effects of a cure to said pandemic. No
| amount of signed contracts would protect the company from the
| sheer volume of people marching to take their heads.
| refurb wrote:
| This should not surprise anyone. Giving an exemption from vaccine
| injury is pretty standard and there is a fund for payouts if
| children are injured by a vaccine. This isn't the only exemption.
|
| https://en.m.wikipedia.org/wiki/National_Childhood_Vaccine_I...
| aaron695 wrote:
| "This is a unique situation where we as a company simply cannot
| take the risk if in ... four years the vaccine is showing side
| effects,"
|
| It's going to be well known any of the vaccines available will be
| considered risky.
|
| I'm not sure people are considering how society will react to
| that.
| IfOnlyYouKnew wrote:
| That's probably... fine?
|
| these vaccines are developed in a process far more open than any
| typical pharmaceutical research. The risks at issue here are
| unlikely to be of the bad-faith variety that can be discouraged
| with liability.
|
| Instead, these will be genuine known and unknown unknowns. There
| will be a lot of scrutiny, which will allow governments and the
| public at large to make these decisions under uncertainty with
| the benefit of the best possible information at the time.
|
| With the company not enjoying a significant informational
| advantage, the moral and practical case for liability just
| doesn't make any sense.
|
| That is a standard approach for the otherwise intractable
| collision of a legal system that apportions the damages of
| anything that goes wrong on the party mostly responsible for it,
| and the medical reality of almost all interventions coming with
| _some_ potential for grievous harm: by default, your surgeon
| would always be "responsible", in sense of civil law, not
| morality or criminal law. Because the general principle allocates
| responsibility with those making decisions.
|
| "Informed consent" is about getting you into a position to make
| decisions, and thereby share in the responsibility.
| mrgordon wrote:
| Well put
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(page generated 2020-08-01 23:00 UTC)