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The Eagle

Britain Wasted £600M Of Taxpayers' Money On Useless Flu Drugs Stockpiled By Government In Case Of Pandemic

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And yet another colossal case of "Big Pharma" fraud...

Will we see any CEOs jailed?

Well of course not as "Big Pharma" is just like the "too big to fail" banks, they are untouchable and certainly don't care about our health, all they care about is fleecing the tax-payer and lining their pockets.

Britain has spent £600m on a stockpile of influenza drugs that are no better than paracetamol in relieving flu symptoms and are next to useless in preventing a pandemic, a major study has found.

The companies behind the two main anti-influenza drugs Tamiflu and Relenza held back crucial information that would have shown just how ineffective their drugs were in clinical trials, according to the independent scientists who compiled the report.

Their investigation found little or no evidence to support the manufacturers’ claims about the effectiveness of the two drugs and questioned the Government’s rationale for building up an emergency stockpile of 40 million doses.

[...]

Details buried within the 175,000 pages of clinical trials data held by the drug companies revealed that the only benefit of the anti-flu drugs was that they shortened the period of symptoms by about half a day. However, symptom relief was not the reason for justifying an expensive stockpile by the Government.

[...]

More worrying, however, was the evidence indicating that Tamiflu – which makes up about 85 per cent of the stockpile – when taken as a preventative medicine may result in serious side effects, such as kidney problems, high blood sugar and psychiatric disorders such as depression and delirium.

[...]

It took more than four years of arduous negotiations to convince the Swiss company Roche, which makes Tamiflu, and the British firm GSK, the manufacturers of Relenza – a powder taken by inhalation – to release the full details of their 46 clinical trials to the Cochrane collaboration.

After years of stonewalling, GSK relented with its full submission of its 26 Relenza trials last year, which was soon followed by Roche’s release of its 20 Tamiflu trials.

full article here: http://www.independent.co.uk/news/science/britain-wasted-600m-of-taxpayers-money-on-useless-flu-drugs-stockpiled-by-government-in-case-of-pandemic-9249396.html

Weren't the usual bunch of HPC Big Pharma shills (you know who you are ;) ) pushing Tamiflu here in the flu pandemic threads at the time too?

So much for the 'superiority of the scientists'... :rolleyes:

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Presumably now we have the full set of research papers from Roche, the government will be able to claim a refund as Tamiflu does not live up to the claims made for it in 2010.

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Presumably now we have the full set of research papers from Roche, the government will be able to claim a refund as Tamiflu does not live up to the claims made for it in 2010.

You would expect that, wouldn't you?

Somehow I have a feeling that the government won't get a single penny back while the GSK and Roche CEOs will be enjoying their humongous bonuses they got thanks to this fraud.

---

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Seems to follow a predictable pattern:

1) Drug company spies a new market, develops a new drug

2) Realises it's new drug is pretty rubbish (poor efficacy or nasty side effects, or both)

3) Conducts sufficient studies that at least some of them will show positive results, more by statistical probability than anything else

4) Sits on the trials with unfavourable results, overeggs the significance of the other trials

5) Flogs huge amounts of said new drug to the NHS at massive cost via its good mates in the government (funny handshakes or brown envelopes anyone?!)

6) Tries to resist attempts by ineffectual under-resourced regulators to get their hands on the data for as long as possible

7) Truth finally emerges, at which point they are already halfway through this process with another drug and nobody seems to care or learn any lessons about trusting their data...

A very sad state of affairs and I'm surprised that there are no legal ramifications or jail time for the perpetrators of what seems to me to be a clear case of fraud on a huge scale :angry:

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I'm not defending big pharma nor am I advocating the use of these drugs for seasonal flu as they can have bad side effects, however, when H5N1 influenza became big news this type of drug was all they had for the treatment of patients and as a preventative.

They really didn't know what H5N1 was going to do, whether it would go pandemic, and they were terrified of the consequences if it did so understandably in such circumstances it was better to throw whatever they could at such a devastating virus.

Tamiflu was given to the contacts of index patients (fatality rate >60%) and it appeared to work in most cases, even for those showing syptoms if given within 48 hours.

If you look at what was going on at the time, in Cikelet subdistrict, Indonesia for instance, they were very, very scared that H5N1 would go pandemic. Tamiflu was distributed to a large proportion of the residents and they were quarantined in their isolated community. The USA moved their entire stock of Tamiflu to the area in case it spread.

http://www.cidrap.umn.edu/news-perspective/2006/08/third-avian-flu-case-verified-area-possible-indonesian-cluster

When H1N1(2009) Swine Flu started spreading H2H in Mexico City again it was very worrying. There simply isn't time with a virus like flu to do the epidemiology or produce a vaccine. Vaccines were taking about 6 months to produce and nine months before they could be effectively rolled out to the population.

http://www.theguardian.com/world/2009/apr/26/swine-flu-outbreak-mexico-pandemic

So with the potential of these viruses to go pandemic I think it better to have something in place that could help rather than nothing at all even if they were found to be not as effective as you would hope. The government would have been truly damned if they hadn't had Tamiflu stockpiled and the worst had happened. £600M compared to the cost of a high fatality pandemic is worth it in my opinion even if Tamiflu is proven to be entirely useless in retrospect (which I don't actually believe). That's all they had as a potential treatment.

I agree though that Tamiflu should not be given for the milder seasonal flu. The Japanese experiences are well documented but they were using the drug as a preventative against something the vast majority of people recover from with no ongoing complications. That in itself is not a good idea because the flu virus does become resistant to these types of drugs.

As I said I'm not defending Big Pharma, but I do understand why Governments, WHO etc. really had no choice at the time but to stockpile and use Tamiflu as there was no other option.

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I'm not defending big pharma nor am I advocating the use of these drugs for seasonal flu as they can have bad side effects, however, when H5N1 influenza became big news this type of drug was all they had for the treatment of patients and as a preventative.

They really didn't know what H5N1 was going to do, whether it would go pandemic, and they were terrified of the consequences if it did so understandably in such circumstances it was better to throw whatever they could at such a devastating virus.

.

.

.

As I said I'm not defending Big Pharma, but I do understand why Governments, WHO etc. really had no choice at the time but to stockpile and use Tamiflu as there was no other option.

You seem to have quite a bit of knowledge on all this, but I would question the bits in bold... It was a lot of hype over science in my view, and such a state of affairs massively benefitted the drug companies who were shifting high volumes of drugs that they knew were of very questionable benefit. I know you aren't defending Big Pharma, but it sounds remarkably close to arguing that a sugar pill is better than nothing in such a situation because it offers a panacea to those people (publics, governments) who might be bricking it at the thought of a pandemic (which then never materialised). Quarantine and basic hygiene precautions would have been (& were?) much more effective than these drugs in preventing a pandemic, in my opinion.

If it transpires that they did indeed know that these drugs were ineffective, then there should be serious repercussions for those who were caught sitting on unfavourable data.

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It's not dissimilar to paying an insurance premium. You don't expect to get £600m of benefit every time you pay the premium, that would be silly.

In any event since it's a fiscal cost it's little different to any other govt. spend that supports private sector jobs/profits. That in essence is the purpose of all govt spending.

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It's early days to be expecting compensation - we haven't had a post yet from Kurt Barlow. :)

Eh?

I don't think Tamiflu was ever viewed as anything more than a marginal treatment even in its heyday.

I suspect the lead in to this will be another one of The Eagles's rants against teh evil drug companies and their vaccines :rolleyes:

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I'm not defending big pharma nor am I advocating the use of these drugs for seasonal flu as they can have bad side effects, however, when H5N1 influenza became big news this type of drug was all they had for the treatment of patients and as a preventative.

They really didn't know what H5N1 was going to do, whether it would go pandemic, and they were terrified of the consequences if it did so understandably in such circumstances it was better to throw whatever they could at such a devastating virus.

Tamiflu was given to the contacts of index patients (fatality rate >60%) and it appeared to work in most cases, even for those showing syptoms if given within 48 hours.

If you look at what was going on at the time, in Cikelet subdistrict, Indonesia for instance, they were very, very scared that H5N1 would go pandemic. Tamiflu was distributed to a large proportion of the residents and they were quarantined in their isolated community. The USA moved their entire stock of Tamiflu to the area in case it spread.

http://www.cidrap.umn.edu/news-perspective/2006/08/third-avian-flu-case-verified-area-possible-indonesian-cluster

When H1N1(2009) Swine Flu started spreading H2H in Mexico City again it was very worrying. There simply isn't time with a virus like flu to do the epidemiology or produce a vaccine. Vaccines were taking about 6 months to produce and nine months before they could be effectively rolled out to the population.

http://www.theguardian.com/world/2009/apr/26/swine-flu-outbreak-mexico-pandemic

So with the potential of these viruses to go pandemic I think it better to have something in place that could help rather than nothing at all even if they were found to be not as effective as you would hope. The government would have been truly damned if they hadn't had Tamiflu stockpiled and the worst had happened. £600M compared to the cost of a high fatality pandemic is worth it in my opinion even if Tamiflu is proven to be entirely useless in retrospect (which I don't actually believe). That's all they had as a potential treatment.

I agree though that Tamiflu should not be given for the milder seasonal flu. The Japanese experiences are well documented but they were using the drug as a preventative against something the vast majority of people recover from with no ongoing complications. That in itself is not a good idea because the flu virus does become resistant to these types of drugs.

As I said I'm not defending Big Pharma, but I do understand why Governments, WHO etc. really had no choice at the time but to stockpile and use Tamiflu as there was no other option.

Are you trying to get banned - I can't sense a whiff of konspiracy in your post

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You seem to have quite a bit of knowledge on all this, but I would question the bits in bold... It was a lot of hype over science in my view, and such a state of affairs massively benefitted the drug companies who were shifting high volumes of drugs that they knew were of very questionable benefit. I know you aren't defending Big Pharma, but it sounds remarkably close to arguing that a sugar pill is better than nothing in such a situation because it offers a panacea to those people (publics, governments) who might be bricking it at the thought of a pandemic (which then never materialised). Quarantine and basic hygiene precautions would have been (& were?) much more effective than these drugs in preventing a pandemic, in my opinion.

If it transpires that they did indeed know that these drugs were ineffective, then there should be serious repercussions for those who were caught sitting on unfavourable data.

I can understand everything you are saying but with these anti-virals I do believe there is good cause for their use as a treatment until and unless they have categorically been proven to be of no clinical use which is not the case at this time. They are currently being used in the treatment of H7N9 in China and I personally wouldn't go against a specialist treating these severe strains of flu if he considers them helpful. Indeed though, there may be a time in the future when I would change my opinion but we are not there yet.

http://english.cntv.cn/program/newsupdate/20140125/100875.shtml

As for quarantine and basic hygeine, in an ideal world that would be a first course of action in prevention in the community but in the developing world you have the fact that in some areas they are not so educated about public health as in the case with the ebola outbreak in Guinea. With H5N1 I remember one of the Ginting family in Sumatra that was struck down by the virus absconded from hospital as he believed it was black magic at work.

http://www.washingtonpost.com/wp-dyn/content/article/2006/07/23/AR2006072300206_pf.html

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I can understand everything you are saying but with these anti-virals I do believe there is good cause for their use as a treatment until and unless they have categorically been proven to be of no clinical use which is not the case at this time. They are currently being used in the treatment of H7N9 in China and I personally wouldn't go against a specialist treating these severe strains of flu if he considers them helpful. Indeed though, there may be a time in the future when I would change my opinion but we are not there yet.

http://english.cntv....25/100875.shtml

As for quarantine and basic hygeine, in an ideal world that would be a first course of action in prevention in the community but in the developing world you have the fact that in some areas they are not so educated about public health as in the case with the ebola outbreak in Guinea. With H5N1 I remember one of the Ginting family in Sumatra that was struck down by the virus absconded from hospital as he believed it was black magic at work.

http://www.washingto...2300206_pf.html

are you saying these drugs were actually trialled on victims....a sort of human live trial?...surely the numerous pre release tests would have proved they either worked or they didnt.

My understanding is that flu vaccine needs to be for the particular flu being treated...otherwise, it just misses the target,

I suspect the use of Tamiflu et al is just a Government appearing to be concerned and "taking action".

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I can understand everything you are saying but with these anti-virals I do believe there is good cause for their use as a treatment until and unless they have categorically been proven to be of no clinical use which is not the case at this time. They are currently being used in the treatment of H7N9 in China and I personally wouldn't go against a specialist treating these severe strains of flu if he considers them helpful. Indeed though, there may be a time in the future when I would change my opinion but we are not there yet.

http://english.cntv.cn/program/newsupdate/20140125/100875.shtml

As for quarantine and basic hygeine, in an ideal world that would be a first course of action in prevention in the community but in the developing world you have the fact that in some areas they are not so educated about public health as in the case with the ebola outbreak in Guinea. With H5N1 I remember one of the Ginting family in Sumatra that was struck down by the virus absconded from hospital as he believed it was black magic at work.

http://www.washingtonpost.com/wp-dyn/content/article/2006/07/23/AR2006072300206_pf.html

Fair enough, and I agree to a point.

But, RE the bits in bold above (and admittedly not having read all the recent reporting on this), haven't the Cochrane Collaboration just come out and said that they are of no clinical use? And they're the experts in systematic reviews of all the available evidence, are they not?

A specialist will deem these drugs to be clinically helpful based on their understanding of the evidence, since they're not in a position to make any conclusions based on their own personal experience (if someone doesn't get the virus, how can you ever know if it was because of the drug you gave them?). So therefore these specialists are victims of not having been made fully aware of all the available evidence, until now...

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are you saying these drugs were actually trialled on victims....a sort of human live trial?...surely the numerous pre release tests would have proved they either worked or they didnt.

My understanding is that flu vaccine needs to be for the particular flu being treated...otherwise, it just misses the target,

I suspect the use of Tamiflu et al is just a Government appearing to be concerned and "taking action".

The manufacturers try to identify the most common strains in the pipeline and tailor the vaccines to provide protection against these. I believe the effectiveness of the vaccine is estimated to be 70-80% - so basically reduces the incidence of flu in a treated population to about 20% of that of an untreated population.

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are you saying these drugs were actually trialled on victims....a sort of human live trial?...surely the numerous pre release tests would have proved they either worked or they didnt.

No, I'm not saying that at all but as the fatality rate for H5N1 is 60% (thought to be higher in the early days but maybe lower due to possible mild cases) who is to say whether a patient given Tamiflu would recover or not without it's use.

http://www.gilead.com/news/press-releases/1999/10/roche-receives-fda-approval-of-tamiflu-first-pill-to-treat-the-most-common-strains-of-influenza-ab?mode=print

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Fair enough, and I agree to a point.

But, RE the bits in bold above (and admittedly not having read all the recent reporting on this), haven't the Cochrane Collaboration just come out and said that they are of no clinical use? And they're the experts in systematic reviews of all the available evidence, are they not?

A specialist will deem these drugs to be clinically helpful based on their understanding of the evidence, since they're not in a position to make any conclusions based on their own personal experience (if someone doesn't get the virus, how can you ever know if it was because of the drug you gave them?). So therefore these specialists are victims of not having been made fully aware of all the available evidence, until now...

If I contracted H5N1 or H7N9 I would not turn down Tamiflu as a treatment based on a meta analysis of it's efficacy, I'd go with the clinical experience of a specialist on the ground dealing with the patients, wouldn't you?

I'm not convinced by the Cochrane review and I think anything that might help with the treatment of patients should be used if it is thought to be more helpful than not and in the absence of anything else that works on the virus at a molecular level.

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No, I'm not saying that at all but as the fatality rate for H5N1 is 60% (thought to be higher in the early days but maybe lower due to possible mild cases) who is to say whether a patient given Tamiflu would recover or not without it's use.

http://www.gilead.co...a-ab?mode=print

so using tamiflu was a guess?

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If I contracted H5N1 or H7N9 I would not turn down Tamiflu as a treatment based on a meta analysis of it's efficacy, I'd go with the clinical experience of a specialist on the ground dealing with the patients, wouldn't you?

You don't seem to have read the article as the article clearly states that the clinical studies done by Roche showed that Tamiflu was no better than paracetamol! (and paracetamol is a lot cheaper and has less harmful side effects)

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CDC Recommendations for Influenza Antiviral Medications Remain Unchanged

April 10, 2014 -- CDC continues to recommend the use of the neuraminidase inhibitor antiviral drugs (oral oseltamivir and inhaled zanamivir) as an important adjunct to influenza vaccination in the treatment of influenza. CDC’s current influenza antiviral recommendations are available on the CDC website and are based on all available data, including the most recent Cochrane report, about the benefits of antiviral drugs in treating influenza.

CDC considers all of the published evidence available from Randomized Control Trials (RCT) conducted among outpatients and observational studies conducted among hospitalized patients, including benefits and risks from safety data, when issuing recommendations on antiviral treatment of influenza. These CDC recommendations emphasize early antiviral treatment as soon as possible for patients who are severely ill and for those who are at greatest risk for complications from influenza. This includes hospitalized patients with suspected or confirmed influenza, those with severe or progressive illness, and outpatients who are at high risk for influenza complications (for example, young children, people aged 65 years and older, pregnant women, and persons with certain underlying chronic medical conditions). In addition, because other reviews of RCTs and observational studies have found consistent clinical benefit of early oseltamivir treatment in reducing the risk of lower respiratory tract complications such as those requiring antibiotics, persons with uncomplicated influenza who are not in a high risk group and who present within 48 hours of illness onset can be treated with antiviral medications based upon clinical judgment.

One large study that was published recently, “Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A(H1N1pdm09) virus infection: a meta-analysis of individual participant data”, adds to the growing body of evidence which supports that neuraminidase inhibitor treatment can reduce the risk of death in hospitalized patients with influenza. In this meta-analysis of published studies, researchers compiled individual-level data from 78 observational studies across 38 countries on more than 29,000 patients who were hospitalized with 2009 H1N1 influenza virus infection during the 2009-10 pandemic. In this study among patients aged >16 years, treatment with a neuraminidase inhibitor antiviral drug was associated with a 25% reduction in the likelihood of death compared to no antiviral treatment. Early treatment with neuraminidase inhibitor antiviral drugs (i.e., within 48 hours of development of influenza illness) halved the risk of death compared to no antiviral treatment. This confirms findings from previous observational studies in hospitalized influenza patients that the clinical benefit of neuraminidase inhibitor antiviral treatment is greatest when started within two days of influenza illness onset.

A review of RCT data for the influenza neuraminidase inhibitor antiviral medications published by the Cochrane Collaboration updates a previous Cochrane review published in 2012, and raises questions about the value of antiviral medications for the prevention and treatment of influenza. The updated Cochrane review assessed full internal clinical study reports from manufacturers containing published and unpublished data from 46 randomized controlled trials (RCTs) of oral oseltamivir or inhaled zanamivir versus placebo for preventing and treating outpatients with mild illness who were otherwise healthy adults and children. The review concluded that in adults and children with influenza-like illness, early oral oseltamivir treatment shortens the duration of symptoms by approximately 17 hours and 29 hours, respectively, compared to placebo. This finding is similar to results in previously published RCTs which reported a reduction of approximately one day of laboratory-confirmed uncomplicated influenza illness in outpatients by early oral oseltamivir treatment verus placebo. One RCT in outpatients who were aged 1 to 3 years with uncomplicated influenza found a reduction of 3.5 days when oral oseltamivir treatment was started within 24 hours after illness onset. The Cochrane review concluded that inhaled zanamivir reduced symptoms in adults by approximately half a day compared to placebo, but had no significant effect in children. The Cochrane review reported no significant effect of oral oseltamivir treatment of outpatients on hospitalizations for adults or children, and the authors conclude that the treatment trials do not settle the question of whether the complications of influenza are reduced by treatment in outpatients because of a lack of diagnostic definitions.

Systematic reviews of RCTs should include published and unpublished data, and researchers should have full access to these data. CDC welcomes the inclusion of data from previously unpublished RCTs among outpatients in the Cochrane review. However, such a review of data on outpatients with clinically mild influenza-like illness is unlikely to answer the question of whether antiviral treatment reduces severe influenza complications, such as those resulting in hospitalization in generally healthy persons, because much larger numbers of participants would be needed. The studies in the recent Cochrane review were statistically underpowered and not designed to assess the effects of the medications on more severe influenza illness outcomes, such as hospitalizations, intensive care unit admissions, or deaths. Notably, no RCT data are available for antiviral treatment of hospitalized patients with severe influenza illness. Furthermore, the burden of influenza disease is greatest among the elderly, young children, pregnant women, and persons with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, congestive heart failure and diabetes. These groups are at highest risk for developing severe complications from influenza resulting in hospitalization or death, and generally have not been studied in RCTs.

Importantly, the Cochrane review did not consider any data from an abundance of observational studies of oral oseltamivir or inhaled zanamivir treatment. While such studies have inherent design limitations and potential biases, they can inform clinical practice and public health. Observational studies are especially important when data from RCTs are unavailable to address questions relevant to specific outcomes (like severe disease) or to certain high-risk groups, or because having a placebo group would be unethical since antiviral treatment is recommended for these groups. Indeed, many observational studies of antiviral treatment of seasonal influenza or influenza A (H1N1) pdm09 (2009 H1N1) have been conducted among hospitalized patients, including critically ill children and adults. These observational studies from many countries have consistently found that early oseltamivir treatment of influenza patients reduces the duration of hospitalization and risk of severe outcomes such as intensive care unit admission or death. These studies have reported that clinical benefit is greatest when oseltamivir treatment is started within 48 hours of illness onset; however, clinical benefit has still been observed when oseltamivir treatment is started up to less than 5 days after illness onset.

CDC estimates that influenza virus infections in the United States result in an average of more than 200,000 related hospitalizations, and between 3,000 to 49,000 deaths each year, depending upon the severity of the influenza season. CDC continues to emphasize that annual influenza vaccination of all persons aged 6 months and older is recommended, and is the best way to prevent influenza. However, available evidence for seasonal influenza and 2009 pandemic H1N1 virus infections consistently indicates that antiviral treatment, when initiated as soon as possible, can have clinical and public health benefit in reducing severe outcomes of influenza. Therefore, neuraminidase inhibitor antiviral medications continue to be recommended for treatment of influenza.

For a summary of CDC antiviral guidance for the 2013-2014 influenza season, see: http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.

For an outline of ACIP and CDC recommendations and references supporting the statements in this “Have You Heard,” see Recommendations of the Advisory Committee on Immunization Practices (ACIP): Information for Health Care Professionals. This information has been updated from the original “Recommendations of the Advisory Committee on Immunization Practices (ACIP)” available at http://www.cdc.gov/mmwr/pdf/rr/rr6001.pdf.

http://www.cdc.gov/media/haveyouheard/stories/Influenza_antiviral2.html

No doubt there will be comments on the Cochrane Review from the top researchers working on influenza in the coming days.

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Eh?

I don't think Tamiflu was ever viewed as anything more than a marginal treatment even in its heyday.

I suspect the lead in to this will be another one of The Eagles's rants against teh evil drug companies and their vaccines :rolleyes:

All I meant was that we could not reach a balanced judgement on this matter until we had heard your considered defence of the evil Big Pharma corporations. B)

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I suspect the use of Tamiflu et al is just a Government appearing to be concerned and "taking action".

I'm not so sure about that. The widespread use of Tamiflu during the time swine flu was the designer illness of choice saw many of those prescribed Tamiflu going down with nasty chest infections. I think the NHS mass use of drugs - and the threat of avian flu in the third world - makes it an excellent trials ground for new pharma.

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All I meant was that we could not reach a balanced judgement on this matter until we had heard your considered defence of the evil Big Pharma corporations. B)

Any defence of Big Pharma specifically in respect to vaccines comes from the overwhelming evidence that vaccinations are a cheap and effective way of protecting people from a host of nasty diseases.

However I'm a great believer in freedom of choice so if you have more faith in vitamin D, carrot juice and herbal tea be my guest <_<

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I don't think Tamiflu was ever viewed as anything more than a marginal treatment even in its heyday.

I thought it was widely reported during the pandemic frenzy that Tamiflu didn't actually work, so the government were just throwing taxpayers' money to Big Pharma?

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Kurt Barlow, on 10 April 2014 - 12:13 PM, said:

I don't think Tamiflu was ever viewed as anything more than a marginal treatment even in its heyday

I thought it was widely reported during the pandemic frenzy that Tamiflu didn't actually work, so the government were just throwing taxpayers' money to Big Pharma?

from 2009

The trouble with Tamiflu

The companies behind the two leading anti-flu drugs are making millions out of the crisis. But just how effective are their products? Sarah Boseley reports

Sarah Boseley

The Guardian, Thursday 7 May 2009

http://www.theguardian.com/world/2009/may/07/tamiflu-swine-flu-drugs

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