Report reveals resistance found to Roche's Tamiflu in Europe

Report reveals resistance found to Roche's Tamiflu in Europe

Joined: April 1st, 2004, 4:56 pm

January 29th, 2008, 1:34 pm #1


<SPAN class=headline id=lblArticleTitle>Report reveals resistance found to Roche's Tamiflu in Europe</SPAN>

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<SPAN class=body id=lblArticleDate style="FONT-WEIGHT: bold">29 January 2008</SPAN>
<SPAN class=body>A new report is suggesting that significant resistance in Europe has built up against Roche’s influenza treatment Tamiflu.

Preliminary results from the study, carried out by experts at the European Centre for Disease Prevention and Control (ECDC), revealed that some of the H1N1 viruses in circulation this winter are resistant to Tamiflu (oseltamivir). It added that so far, 148 samples of influenza A viruses isolated during November and December from ten European countries have been tested by the EU-funded VIRGIL network and 19 showed evidence of resistance to oseltamivir.

The ECDC noted that 12 of the samples that tested positive for resistance to oseltamivir came from Norway, out of 16 sent for testing. In response, the Norwegian Public Health Institute immediately published an advisory notice to doctors and the public on its website that evening.

The ECDC, the European Commission and the World Health Organisation are currently assessing the significance of the data and an assessment will be published in the coming days. However they were at pains to note that “at this stage it is impossible to say what the level of resistance is in influenza across Europe”.

Nevertheless, the study claims that “the proportion of influenza viruses exhibiting resistance to oseltamivir must be significant, but not as high as in Norway”.

The ECDC trial results were revealed just as GlaxoSmithKline, maker of rival treatment Relenza (zanamivir), said it welcomes the new guidance from the European Medicines Agency on the use of antivirals during a flu pandemic and the recommendation that the availability of more than one antiviral would be useful.

The EMEA has stated that resistance has been observed more frequently, in particular amongst children, with increasing use of Tamiflu. However it highlights that, in contrast, viral resistance to Relenza is extremely rare.



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Joined: April 1st, 2004, 4:56 pm

January 29th, 2008, 1:36 pm #2

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Joined: April 1st, 2004, 4:56 pm

January 29th, 2008, 1:40 pm #3

<P id=slugline>BMJ&nbsp;&nbsp;2005;331:1277&nbsp;(26&nbsp;November), doi:10.1136/bmj.331.7527.1277

reviews
<H2 class=sertitle>Press</H2>
How the media caught Tamiflu
From a bit of a dud to the world's most sought after drug in the space of six months, surely Roche cannot believe its luck with oseltamivir (Tamiflu). Despite a silly name and a lack of convincing evidence that it will have any real impact on an influenza pandemic, sales and recognition of the drug frequently dubbed "our best hope against bird flu" have leapt through the roof.
Between 1999 and 2002 Roche sold just 5.5 million treatments. Next year the total sales of oseltamivir are projected at 150 million. Roche's share price has soared this year by 60%.
Sir Liam Donaldson, England's chief medical officer, has noted that doctors have little idea how effective oseltamivir antiviral tablets would actually be during a pandemic.
But this has not affected demand and Roche cannot make the drug quickly enough for the 50 countries currently stock-piling it. On the internet Tamiflu is trading at five times its retail price.
Of course in large part Roche has Mother Nature to thank for the turn of events. The rising spectre of an influenza pandemic and no immediate vaccine to fight it has made bird flu the medical story of the year and given Tamiflu a public profile comparable to that of Viagra.
But that's not the whole story. Roche has naturally made the most of this golden opportunity and its public relations machine has naturally milked Tamiflu for all it was worth.<A href="http://www.bmj.com/cgi/content/full/331 ... "></A>[sup] [/sup]
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<TD class=caption>Credit: CHRIS RAOBURN/PA/EMPICS/PA

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Like most other drug companies, its marketing department uses<SUP>
opinion leaders—usually professors or senior doctors from medical schools who can provide the credibility that company representatives cannot. In the case of oseltamivir, it is Professor John Oxford of Queen Mary College, London, who has led the drug's endorsement.
He routinely provides the media with positive comments about Tamiflu and has even appeared in promotional videos for the drug. However, his ties to Roche are rarely if ever mentioned in the mainstream press. He is also the scientific director of and a share owner in Retroscreen Virology, which has had contracts with Roche.
As a media pundit he denies any conflicts of interest. He told the BMJ: "I believe these drugs are very useful and I've also worked with Johnson and Johnson and Glaxo (firms that make rival treatments). I've not tried to conceal anything. But you can't mention all your grants and links every time you appear on the television or every time you're quoted, there just isn't enough time."
But other doctors believe opinion leaders should make time to do this. Joe Collier, professor of medicines policy at St George's Hospital Medical School, London, and a former editor of the Drug and Therapeutics Bulletin, said, "It's a real dilemma who to believe." He said that an opinion leader might be totally impartial but on the other hand he or she might not.
"The fact is we have to be suspicious," Professor Collier said, adding, "Perhaps the media should speak to more than one person when it's looking for comments or information. Somehow the mainstream media needs to think more on what it's going to do about this."
Respected figures in medical research, such as Professor Colin Blakemore, the chief executive of the Medical Research Council, have noted the need for leading doctors to work closely with industry to facilitate drug development. But surely this doesn't abrogate doctors' responsibility to be transparent about the nature of that relationship—nor does it relieve the press of its duty to alert readers to potential conflicts of interest.
For several years I worked as medical correspondent at New Scientist magazine, where it was standard practice to seek several opinions on a single issue. When I moved from this ivory tower to Fleet Street I was somewhat taken aback at the "any ologist will do" attitude when obtaining quotes for a story—although I soon became aware of the time constraints that made this necessary.
Another Fleet Street health correspondent whom I spoke to this week said, "When you've got three articles to write in an afternoon and news desk shouting at you for copy, you just want to get a quote that you need to make the story; the last thing on your mind is checking the background of everyone you've quoted."
The correspondent added, "Anyway, how do we know that any doctor hasn't benefited financially from a drug company; I'm not sure there are that many left who haven't."
A spokesman for the drug industry's UK umbrella group, the Association of the British Pharmaceutical Industry, denied the media was being manipulated. "In fact I think there's a sense that journalists will usually ring the person they think will give them the quote they want."
Alessandro Liberati and Nicola Magrini, writing in the BMJ two years ago, called on opinion leaders to avoid "double standards" and adopt the same rigorous ethics and transparency when speaking to patients and policy makers that they would be expected to show when writing for peer reviewed journals (<A name=""><!-- null --></A> BMJ 2003;326: 1156-7<!-- HIGHWIRE ID="331:7527:1277:1" --><NOBR>[<FONT color=#cc0000>Free</FONT>&nbsp;Full&nbsp;Text]</NOBR><!-- /HIGHWIRE -->).
You might add that newspapers and broadcasters will need to raise their game, as well. And so far the signs are not good.

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<STRONG>Michael Day</STRONG>, <EM>freelance journalist</EM></STRONG>
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London <SPAN id=em0>[url=mailto:miday@f2s.com]miday@f2s.com[/url]</SPAN>
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