H1N1 drug Tamiflu effectiveness questioned

The medical journal BMJ (British Medical Journal) has claimed that anti-viral drugs, such as Tamiflu, may be ineffective against influenza viruses, including the H1N1 swine flu virus, when taken by otherwise healthy people.
The prestigious journal has, in a series of articles, said that the Swiss pharmaceuticals giant Roche, which sells the drug as Tamiflu, has concealed the detailed data required to justify claims of its effectiveness, reports New Scientist.
“Although billions have been spent on oseltamivir in the face of pandemic influenza,” the journal states, investigators “found that the public evidence base for this global public health drug was fragmented and inconsistent”.
The British Medical Journal report follows a World Health Organization (WHO) report a couple of weeks ago which indicated that the H1N1 swine flu virus may now be resistant to Tamiflu. (ANI)

Tamiflu Supply to North

It is good to see that humanitarian aid to North Korea will be resumed after nearly two years of suspension. South Korea has decided to provide 500,000 doses of Tamiflu and other anti-viral drugs to the North to help fight the spread of swine flu. The decision came Thursday as Pyongyang accepted Seoul's offer of the medicines.
The provision of the drugs will mark the first humanitarian aid from the Seoul government to the North since President Lee Myung-bak took office in February 2008. Pyongyang has yet to accept 10,000 tons of corn aid offered by the South in October, apparently because of its dissatisfaction with the relatively small amount of assistance and the strings attached to it.
The North's decision on the medicine aid reflects its need for urgent action against the epidemic, also known as influenza A (H1N1). The decision was made immediately after the South conveyed its intention to help to the North at the instruction of President Lee. During a Cabinet meeting Tuesday, he told his ministers to provide ``unconditional" aid to help North Korea contain the highly contagious virus.
On Wednesday, the North made its first report of nine cases of the influenza outbreak in its capital Pyongyang and northwestern Sinuiju bordering China. However, there was no report of deaths from the flu attacks. However, a Seoul-based civic group quoted unconfirmed reports that the influenza virus has killed about 50 people in the North since early last month.
Unification Ministry officials are contacting North Koreans to decide details about how and when to transport the drug supply to the North. We hope the South will swiftly deliver the anti-viral drugs to the North so that they will become available to patients there. The sooner, the better as early action is pivotal in blocking a further spread of the epidemic. If necessary, the South should send medical equipment and medical staff to the impoverished North to better cope with swine flu.
We also expect that the medicine provision will serve as a catalyst to increase the South's humanitarian aid to the isolated country. The North is suffering from a food shortage. Thus, the Seoul government needs to persuade Pyongyang to accept its food assistance in order to feed millions of North Koreans fighting hunger. It goes without saying that humanitarian assistance should be offered without any preconditions. But, such aid may contribute to easing tensions on the Korean Peninsula and mending ties between the two rivals.

Doubt cast on Tamiflu effectiveness

Researchers are questioning the effectiveness of the influenza treatment Tamiflu.
A study published in the British Medical Journal has found that the data relied on by the flu drug's manufacturer Roche cannot be verified.
The researchers say there is insufficient evidence to back Tamiflu's effectiveness and that more studies are now underway.
But the Australian Government is standing by its decision to spend hundreds of millions of dollars stockpiling the drug.
The Cochrane Collaboration is a global network of researchers that considers itself a scientific watchdog, regularly reviewing drugs.
It has just updated its previous review of Tamiflu. In the process, scientists followed up concerns held by a Japanese doctor about a lack of evidence about the drug's benefits.
Professor Chris Del Mar is the coordinating editor of the Cochrane Collaboration's acute respiratory infections review group. He is also the Dean of Medicine at Bond University.
He says doubt has been cast on studies relied on by the drug manufacturer Roche.
"The most important finding we found, which is a change from the previous review, was that we didn't have enough data to know whether it reduces the complications of influenza," he said.
"There was a study written by professor Laurent Kaiser from Geneva in Switzerland, which was a summary of about 10 different trials that had been conducted by Roche Pharmaceuticals.
"When we actually put the data together and analysed them, we found that we couldn't draw the conclusions that [professor] Kaiser had drawn. And so we felt very insecure about that. In fact we didn't think it was proper to use those data.
"When we wrote to [professor] Kaiser and said 'can you give us these data because we need to sort it all out properly', he wrote back and said, 'I'm very sorry I don't have the data'.
"That's a very weird thing to say. And he referred us to Roche. He said, 'You'll have to go and talk to the pharmaceutical company that funded it'."
Data deficient
Professor Del Mar says that Roche never gave out the data, only giving some tables of data that were not what was needed.
"I can only speculate. It would be pure guesswork. But I do know that this is a drug which has made a lot of money based on the conclusions drawn from this and maybe they're not keen for other scientists to scrutinise it in the way that the Cochrane Collaboration does," he said.
Professor Del Mar is reluctant to accuse Roche of making money under false pretences.
"I do think that we need the data before we can draw conclusions and that's why we've had to withdraw that conclusion that we had previously made," he said.
He says it is embarrassing that previous findings and recommendations had holes in them.
"It's something that makes me feel that we were rather naive as an organisation," he said.
People will be now wondering about the efficacy of the swine flu vaccine.
Professor Del Mar says there is reason to doubt other studies that drug companies cite to support the use of their drugs.
"I think this does call into question a lot of things about scientific debate and I am worried about it," he said.
The researchers concluded there is insufficient evidence to back Tamiflu's effectiveness in seasonal flu and they are unsure whether the same applies in pandemics like swine flu.
The Australian Government stockpiled millions of dollars worth of the drug during the swine flu pandemic and chief medical officer Jim Bishop stands by the move.
"What we found early on with the swine flu epidemic was that the particular virus that was causing it was quite sensitive to antivirals, both Tamiflu and Relenza," he said.
He says they have evidence to contradict the study's claims that Roche does not know whether or not their findings can be generalised from seasonal flu to a pandemic.
The World Today requested an interview with a Roche representative but the company instead released a statement accusing the scientists of carrying out an incomplete review.
The company also says it stands behind the robustness and integrity of its data.

Research Finds New Tamiflu Benefits

As news of the H1N1 swine flu pandemic first broke, everyone scrambled for the drug Tamiflu. Governments released stockpiles, but still pharmacies frequently ran out of it.
Doctors prize Tamiflu because it is one of the few weapons that fights flu after a person has started showing symptoms.
But new research has suggested that the benefits of Tamiflu may have been overstated.
A British review found little evidence that the drug reduces serious complications of the flu, such as pneumonia, in otherwise healthy people. And overall, Tamiflu appears to cut the length of illness by less than one day.
However, a study on H1N1 patients in China suggested that Tamiflu may help stop the virus from spreading.
Patients treated with Tamiflu were more likely to have eliminated the virus from their systems within 5 days, meaning they would no longer pass it on.
So doctors still recommend the drug to high-risk groups -- such as those with chronic health problems like asthma or heart disease -- and to those who have close contact with them.

Do you have to wait between Tamiflu and vaccination?

Q. My son got fever seven days before and took Tamiflu medicine. Can he get H1N1 vaccine now? Or does he have to wait for some time to take H1N1?
A. Tamiflu helps reduce the symptoms of the flu. It does not act as a vaccine or cure.
However, health professionals in general recommend anyone feeling sick wait and recover before getting a vaccine. Some forms of the vaccine, the nasal spray in particular, could heighten flu-like symptoms at the time of immunization.
So make sure your son feels 100 percent before heading to the clinic.

Study Finds Limited Benefit From Tamiflu

British researchers said there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the drug reduces swine flu hospitalizations and deaths.
Researchers at the Cochrane Review, an international nonprofit that reviews health information, looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The papers were published online Tuesday in the British journal, BMJ.
The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.
Fiona Godlee, BMJ's editor, said the papers cast doubt not only on how safe and effective Tamiflu is, but on the drug regulatory system that approved it. "Governments around the world have spent billions of pounds (dollars) on a drug that the scientific community now finds itself unable to judge," she said in a statement.
But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.
"This will not change our (Tamiflu) guidelines," said Charles Penn, a WHO antivirals expert. Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.
And Roche, the maker of Tamiflu, defended the drug, saying in a statement that they "firmly believe in the robustness of the data."
Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people -- precisely the policy Britain has adopted to fight swine flu.
In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor's recommendation.
In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.

Does Tamiflu work?

A new analysis is questioning the value of the widely used antiviral drug Tamiflu for treating the flu.
Chris Del Mar of Bond University in Australia led a team of researchers that updated the widely respected Cochrane Collaboration's 2005 evaluation of the effectiveness of Tamiflu and other so-called neuraminidase inhibitors by compiling data from 20 studies that have examined the drugs.
The analysis, published online by the British medical journal BMJ, concludes that the available evidence indicates that the drugs have a "modest effectiveness" against the symptoms of the flu in otherwise healthy adults -- cutting symptoms by about a day. But the group concluded a "paucity of good data has undermined previous findings" suggesting Tamiflu could prevent severe complications from the flu. In an accompanying paper, Nick Fremantle and Melanie Calvert from the University of Birmingham reviewed additional studies and concluded the drug may reduce the risk of pneumonia in otherwise healthy people who get the flu, but the benefit is probably very small and needs to be weighed against potential side effects.
In an article accompanying the analysis, a researcher involved in the analysis criticizes Roche, the company that makes Tamiflu, for failing to provide details about studies that have been conducted to evaluate the drug. Peter Doshi of the Massachusetts Institute of Techology argues that the case illustrates the problems involved when pharmacecutical companies conduct medical research. Fiona Godlee, the journal's editor, notes that governments have spent billions of dollars to stockpile the drug to fight flu pandemics like the H1N1 pandemic and are unable to judge its effectiveness.
In responses to the analysis and to questions from the journal, James Smith from Roche defended the drug's effectiveness, saying studies had clearly demonstrated the safety and usefulness of the drug and argued that government regulatory agencies have full access to all the company's data.