Showing posts with label Sarah Boseley. Show all posts
Showing posts with label Sarah Boseley. Show all posts

Had Novartis won, it would have set a precedent for patenting of other medicines in India, delaying their reaching the poor


The battle for affordable, life-saving medicines for poor countries was once waged on first-world city streets with banners and placards. But for some years now it has been a long-hard legal slog in offices and courtrooms.


A decade or more ago, it was almost entirely about access to Aids drugs. The firms which made them at prices too high for all but citizens of the rich world were shamed and left on the back foot by campaigners in the US and Europe.


The activists won some famous victories, breaking the patent stranglehold of the big companies and enabling the sale of cheap generic copies. Millions of people with HIV are alive and leading normal lives in poor countries as a result.


The multinational drug companies, however, have been working hard to prevent further erosion of their profits by generic, copycat manufacturers whom they once openly called pirates.


The companies, with support from the US and European governments which want a profitable drug industry, have worked to tighten patent protection for new medicines through national laws and trade agreements. India has been the main focus in its historical role as the pharmacy of the developing world.


Under the World Trade Organisation's trade-related intellectual property rights (Trips) rules, India agreed to bring in patents for drugs in 2005. Drugs without patent protection before that date can still be copied and sold cheaply to developing countries by generics companies.


Novartis began seeking patent protection for its cancer drug Glivec as soon as the law came into force, but as the drug was already on the market the Swiss company could not make a standard application. Instead, it sought a patent for a slightly altered version, which it said made the drug easier to absorb. It argued that this was innovation under Indian law and deserving of a patent.


The stakes were high. Glivec costs around £1700 a month. Indian generic copies cost around £115.


Campaigners, already concerned that the Indian patent law would delay important new medicines reaching the poor, could see that if Novartis won its legal case, the "evergreening" of drugs by other companies would become routine. Patents usually expire after 20 years, meaning it could be decades more before prices would drop.


"Had the Novartis case been successful, it definitely would have extended massively the ability to patent other medicines within India," said Jennifer Cohn, the medical director for Médecins Sans Frontières' access campaign.


It is an important victory, say the campaigners, but they still feel embattled. New classes of HIV drugs are being patented now in India and will not reach Africa for many years as a result, Cohn said. The same is true of new tuberculosis and hepatitis C drugs.


Campaigners also worry about trade agreements such as the Trans-Pacific Partnership, which is being negotiated between Australia, Canada, the US, Malaysia, Chile, Mexico, Peru, Vietnam and others, and require stringent patent protection.


The companies and their supporters, however, argue strongly that without the financial reward that long-lasting patents offer, they will not have incentives to develop new medicines. They also threaten to boycott countries that will not allow them a monopoly on their own drugs.


No one thinks there are any simple solutions.






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via World news: India | guardian.co.uk http://www.guardian.co.uk/world/2013/apr/01/novartis-patent-ruling-affordable-medicines

Strains of drug-resistant flu are said to be able to pass from one human to another


Increasing numbers of cases of swine flu are being detected that are resistant to Tamiflu, the drug the UK and rest of the world stockpiled to fight a pandemic, according to scientists calling for greater global monitoring.


Even more worryingly, these strains of flu are appearing in patients who have never been treated with the drug, which means the strains are able to pass from one human to another.


Tamiflu, generic name oseltamivir, is one of the few treatments available for pandemic swine flu, although it is thought to be of limited effectiveness. The reluctance of the manufacturer Roche to release all the trial data has made it difficult to ascertain how limited. Nonetheless the drug can save lives if used early in the course of the illness.


Resistance to the drug has been shown before, but the new Australian data on its steady growth and the apparently easy transfer from one person to another of Tamiflu-resistant flu strains will alarm public health experts.


The data comes from Dr Aeron Hurt, of the World Health Organisation collaborating centre for reference and research on influenza in Melbourne. He and his colleagues have found that approximately 2% of H1N1pdm09/swine flu cases are resistant to Tamiflu. While that is not large, an increasing proportion of the patients have never been treated with the drug – so they have contracted a form of flu that is already resistant to it.


In 2011, the team detected the most widespread cluster to date of Tamiflu-resistant H1N1 swine flu cases in Newcastle, New South Wales. This, they say, is further evidence of the ability of this drug-resistant strain to circulate in the community.


Tamiflu-resistant strains of H1N1pdm09 have been identified in Europe but only on an ad hoc basis, said Hurt. "However, the trend observed in Australia of a greater proportion of resistant cases being detected in untreated community patients is also being observed both in the USA and Europe," he said.


Hurt, who presented his findings to the annual scientific meeting of the Australasian Society for Infectious Diseases in Canberra, said animal studies had confirmed that the latest drug-resistant strains could be passed on more easily than drug-resistant strains in the past.


"Sustained global monitoring for the emergence of resistance is important to underpin public health and guidance for clinical management. Surveillance schemes should assess frequency of resistance in the community and in specific patient groups receiving treatment, such as severely immunocompromised, seriously ill patients in hospital, and patients not responding to antiviral therapy," said Hurt.


"Further studies to better understand influenza-virus infections in these patients and to improve antiviral treatment strategies are needed."






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via The Guardian World News http://www.guardian.co.uk/world/2013/mar/18/swine-flu-resistant-tamiflu-scientists

Mississippi baby now effectively free of the virus will cause excitement, but is likely to mean little for those already infected


Scientists on a quest to cure HIV will be enormously encouraged, as well as intrigued, by the reports from Mississippi in the US of a two-year-old child who had the virus at birth but who is now apparently free of it.


It sounds like one of those serendipitous breakthroughs that have characterised the fight against HIV and Aids, such as the discovery that some African sex workers are resistant to the virus and the realisation that people taking antiretroviral drugs, which suppress the levels of HIV in the body, are unlikely to infect their partners.


But is this the big one? Have doctors stumbled across the cure for HIV? Unfortunately not. This is progress and will open up new avenues for scientists to explore, but the implications for those already infected or even the still significant numbers of babies born with the virus in the developing world are sadly probably slight.


The Mississippi baby became infected because the mother had not been tested in early pregnancy. If she had, the woman would have been put on antiretroviral drugs, the baby would have been delivered by caesarean section and then given a short course of drugs – all of which would almost certainly have prevented transmission of HIV from mother to child.


When doctors realised the mother had HIV, it was too late for the standard prevention package, so they implemented plan B, which was to put the baby on the full three-drug cocktail straight away. It is already known that the sooner after infection an adult goes on the drugs, the better the outcome. But here, it seems, the drugs hit the virus so hard and so early that it all but disappeared.


This is what scientists call a "functional cure". Traces of the virus remain, but they are inactive even though the mother disappeared from follow-up and the baby was off drugs for five months. This was the serendipitous event – other babies will have been treated the same way but remain on the drugs, so it is impossible to know whether they are HIV-free or their HIV is just drug-suppressed. And the scientists are anxious they should not stop the drugs now as a result of this case. One HIV-free baby may be exceptional. There could be some reason, as yet unknown, why this baby is different from others.


Hopefully, scientists will establish that any newborn baby can be functionally cured in this way. But they do not expect the same to be true of children whose HIV infection is discovered later – let alone adults. They think this has to do with hitting the virus at the earliest possible moment after birth, before it has reached the CD4 cells in the immune system which harbour a reservoir of HIV in adults that the drugs are never quite able to wipe out.


The Mississippi baby was unusual, because the vast majority of pregnant women in wealthy countries are tested for HIV and most infections in babies are prevented – in the UK as many as 98%.


That is not so in poorer countries. In the developing world, there is still a big and tragic problem. In 2008, the latest year for which there are figures, 430,000 babies were infected at birth. That is a drop in the numbers, but far too high and desperately sad for parents and child.


It might seem as though the Mississippi baby breakthrough will, therefore, save thousands of lives in the 25 countries in sub-Saharan Africa, where most of these infections are taking place. But there is already a way of preventing these infections using drugs – which is far better than a functional cure using similar drugs. The problem is not how to do it – it is to ensure the drugs and the medical staff are in the right place at the right time to treat mother or baby or both. There are plenty of pregnant women in Africa known to have HIV who cannot get the treatment they want and need to protect their child. It is not very likely that the clinics they attend will instead have the three-drug combinations that the Mississippi baby received from skilled nursing staff within hours of birth.


Real excitement is justified by the Mississippi discovery – but it is what it tells scientists still trying to figure out how to defeat HIV that matters. Any practical applications are a long way further down the line.






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via The Guardian World News http://www.guardian.co.uk/society/2013/mar/04/hiv-cure-is-breakthrough-seems