Τετάρτη 22 Φεβρουαρίου 2012

VΙREAD is Associated With Long-Term, Irreversible Kidney Damage, Η ΧΡΗΣΗ ΤΟΥ VIREAD (ΤΕΝΟFOVIR) ΣΥΝΟΔΕΥΕΤΑΙ ΑΠΟ ΑΝΕΠΑΝΟΡΘΩΤΗ ΝΕΦΡΙΚΗ ΒΛΑΒΗ

By Courtney McQueen
Published: Feb 15, 2012 9:11 am


Αποτελέσματα μεγάλης σύγχρονης μελέτης επιβεβαιώνουν οτι το Viread (βασικό φάρμακο αντιρετροϊκής θεραπείας) συστατικό επίσης των φαρμάκων truvada και Atripla προκαλεί νεφρική βλάβη στους ανθρώπους με HIV.

Τα αποτελέσματα της μελέτης αποτελούν επίσης ένδειξη οτι η νεφρική βλάβη είναι μη αναστρέψιμη.

Οι συγγραφείς συνιστούν οι ασθενείς να γνωρίζουν την κατάσταση λειτουργίας των νεφρών τους πριν την ένταξη του viread στη φαρμακευτική αγωγή τους.

Για τους ασθενείς που δεν έχουν κάποιο πρόβλημα νεφρικής βλάβης το φάρμακο μπορεί να χρησιμοποιηθεί.

Προηγούμενες μελέτες έχουν αναδείξει οτι τα άτομα με HIV έχσουν μεγαλύτερη πιθανότητα εμφάνισης νεφρικής βλάβης αφου τόσο τα αντιρετροϊκά όσο και και η ίδια η HIV λοίμωξη μπορούν να προκαλέσουν νεφρική βλάβη.


Viread Is Associated With Long-Term, Irreversible Kidney Damage

Results from a recent large study confirm that Viread, which is also a component of Truvada and Atripla, causes kidney damage in people with HIV.
The results also indicate that the kidney damage increases with each year of exposure and is irreversible.

Based on the results, the study authors recommended frequent kidney function monitoring for people who take Viread, Truvada, or Atripla.

They also suggested that people who already have kidney problems may need to consider other antiretrovirals.


“Patients need to be aware of their kidney disease risks before they start therapy, and this should influence the medications that they choose in consultation with their doctor,” said Dr. Michael Shlipak, a professor of medicine at University of California, San Francisco and lead author of the study, in a press release.


“For an otherwise healthy patient, the benefits of [Viread] are likely to exceed the risks, but for a patient with a combination of risk factors for kidney disease, [Viread] may not be the right medication,”
he added.

“We do not know the long-term prognosis for… patients who stop [Viread] after developing kidney disease.”

Previous research has indicated that people with HIV are more prone to kidney disease than people without HIV, because both antiretrovirals and the HIV virus, which can infect and kill kidney cells, can damage the kidneys (for more information on kidney disease in people with HIV, see related AIDS Beacon news).

Viread (tenofovir), in particular, has been associated with loss of kidney function (see related AIDS Beacon news).
Viread is a nucleoside reverse transcriptase inhibitor that can be prescribed separately or as component of Atripla (efavirenz/emtricitabine/tenofovir) or Truvada (emtricitabine/tenofovir).

According to the study authors, Viread’s role in causing kidney disease is still controversial, as not all studies have found evidence that Viread causes kidney damage.
The authors hypothesized that this discrepancy may be due to varying patient populations (for example, patients with more or less pre-existing kidney damage) or other factors.

In this study, the researchers set out to definitively determine whether Viread use over time is associated with kidney damage. The study included 10,841 HIV-positive United States veterans who started antiretroviral therapy for the first time between 1997 and 2007.

The average participant age was 46 years old. Almost all participants (98 percent) were male and just under half (49 percent) were African-American.

Researchers measured participants’ kidney function and HIV-related outcomes, such as viral loads (amount of HIV in the blood) and CD4 (white blood cell) counts.

They also measured their blood pressure and blood glucose levels, since high blood pressure and diabetes can also lead to kidney damage.

Results showed that each year of Viread use was associated with a 30 percent higher risk of having abnormally high levels of protein in the urine, a sign of kidney damage. In addition, each year of Viread use increased the risk of a rapid decline in kidney function by 11 percent and increased the risk for chronic kidney disease by 33 percent.

Any exposure to Viread was associated with about a 50 percent increased risk of high levels of protein in the urine, rapid kidney function decline, and chronic kidney disease.


There was no evidence that taking Viread with protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or the antiretroviral boosting agent Norvir (ritonavir) increased the risk of kidney damage.

Results also showed that stopping Viread did not decrease the risk of abnormal protein in the urine or rapid loss of kidney function, although it did slightly decrease the risk for chronic kidney disease.
The study authors concluded that damage caused by Viread is likely irreversible.

Various types of kidney damage were more or less likely after certain lengths of time taking Viread.
For example, risk of abnormally high levels of protein in the urine was higher in study participants who had taken Viread for more than three years, while risk of rapid decline in kidney function decreased after three years.

Traditional risk factors for kidney disease, such as high blood pressure and diabetes, did not increase the risk of Viread-induced kidney damage.

For more information, please see the study in the journal AIDS (abstract) or the press release from the University of California, San Francisco.

ΔΙΚΑ ΜΑΣ ΣΧΟΛΙΑ:

Το viread της φαρμακευτικής εταιρείας GILEAD, φαίνεται πως παρά την επιτυχία του και τα πολλά κέρδη που προσέφερε στην εταιρεία παραγωγής του,
έχει μια αμαρτωλή προϊστορία.


Μελέτη με 1.000 εκδιδόμενα άτομα είχε ξεκινήσει στην Καμπότζη από ερευνητές του πανεπιστημίου της Καλιφόρνια Σαν Φραντσίσκο με χρηματοδότηση του Eθνικου Ινστιτούτου Υγείας (ΝΙΗ) των ΗΠΑ και του πανεπιστημίου της Νεας Ν. Ουαλίας.

Οι μισές από τις γυναίκες θα έπαιρναν Viread και
οι άλλες μισές ένα πλασματικό φάρμακο (placebo).


Ενα χρόνο αργότερα οι ερευνητές θα συνέκριναν (ανερυθρίαστα) τις δύο ομάδες.
Μελη των τοπικών ομάδων εκδιδομένων γυναικών αρνήθηκαν να συμμετάσχουν.


Ακτιβιστές στο Παγκόσμιο Συνέδριο AIDS στην Μπαγκόνγκ διαμαρτυρήθηκαν επίσης λέγοντας πως οι εκδιδόμενες ήταν αντικείμενα εκμετάλλευσης.

Οι διαδηλωτές καθοδηγούμενοι από την ACT UP PARIS κατηγόρησαν τους ερευνητές για σκόπιμη ανεπαρκή εκπαίδευση των εθελοντών προκειμένου να εξυπηρετηθεί η μελέτη.


Δέστε το σχετικό δημοσίευμα της εποχής:

Tue, Aug. 03, 2004
Cambodia Prime Minister Opposes Testing Anti-HIV Drug
by KER MUNTHIT, Associated Press


PHNOM PENH, Cambodia - Prime Minister Hun Sen said Tuesday he opposes the testing of drugs on Cambodians, a position that could derail a planned trial for an anti-AIDS medicine here.

His remarks seemed directed at a test, partially funded by the Bill and Melinda Gates Foundation, of the drug Tenofovir DF by the California-based biotech company Gilead Sciences Inc.

"Please, don't use Cambodians for (any drug) trial," Hun Sen said at a groundbreaking ceremony for a hospital, noting that his country had been selected to test AIDS medication. "If a trial is needed, please do it on animals, and don't use Cambodians."

Hun Sen did not single out any project, but his remarks come amid a controversy on the ethics of testing Tenofovir, called Viread DF by Gilead Sciences Inc., in Cambodia.

The study, which seeks to recruit almost 1,000 sex workers, is being conducted by researchers from the University of California San Francisco with funding from the U.S. National Institutes of Health, and the University of New South Wales.

Half those volunteers in the Cambodia experiment will be given Viread, and the others will take a placebo. A year later, researchers will compare the two groups to determine if significantly fewer volunteers taking Viread were infected with HIV than those receiving the dummy pill.

Members of a local sex workers' rights group, Women Network for Unity, said in March they would refuse to participate, citing a lack of insurance against potential side effects.

Activists at last month's International AIDS conference in Bangkok also protested the test, saying the prospective participants were being exploited.

The protesters, led by the AIDS activist group Act Up, accused the researchers of purposely providing insufficient prevention education to the volunteers because it needs infection data to analyze Viread's potential to protect against the virus.

The protesters also demanded that the company take care of the lifetime medical needs of any volunteers who contract AIDS during the experiment - partially funded by the Bill and Melinda Gates Foundation.

The study was approved by the ethics council of Cambodia's Health Ministry last year, but has not yet formally started, said Khol Vohith, a research officer at Cambodia's National Center for HIV/AIDS, Dermatology and Sexually Transmitted Diseases.

Saphonn Vonthanak, a chief of the center's research unit, said he heard about Hun Sen's remarks but was unable to comment on them or say if the Cambodian leader was referring to the Viread study. He said the center would seek clarification.

Cambodia's current HIV infection rate is 2.6 percent among people of 15-49 age group, the highest in Southeast Asia.

Women Network for Unity welcomed Hun Sen's remarks, saying he was "defending the interests of the Cambodian people."

"I'm very glad with what the prime minister has said. I wish for the study to fail, and I will get our girls together to celebrate when it actually fails," said Sou Sotheavy, one of the group's leaders.


from ACT UP/Paris
http://medilinkz.org/central-africa/cameroon/12040.html

Novartis Sues Indian Government over Health Safeguards in Indian Patent Law

ΕΠΕΙΓΟΝ !!!
H novartis ΜΗΝΥΕΙ την Ινδική κυβέρνηση για τον Ινδικό νόμο για τις Φαρμακευτικές Πατέντες

ΕΡΩΤΗΣΗ ΔΙΚΗ ΜΑΣ
ΑΝ ΚΕΡΔΙΣΕΙ Η ΦΑΡΜΑΚΟΒΙΟΜΗΧΑΝΙΑ Η ΕΛΛΗΝΙΚΗ ΚΥΒΕΡΝΗΣΗ ΘΑ ΜΠΟΡΕΣΕΙ ΠΟΤΕ ΝΑ ΥΠΟΣΤΗΡΙΞΕΙ ΤΟ ΕΛΛΗΝΙΚΟ ΓΕΝΟΣΙΜΟ - ΓΕΝΕΡΙΚΟ ΦΑΡΜΑΚΟ... ΓΙΑ ΤΟ ΟΠΟΙΟ ΠΡΟΣΠΑΘΟΥΝ ΝΑ ΜΑΣ ΠΕΙΣΟΥΝ ΟΤΙ ΚΑΝΟΥΝ ΤΑ ΠΑΝΤΑ...?


48 HOURS OF ACTION // 22-23 FEBRUARY 2012
48 ώρες δράσης // 22-23 Φεβρουαρίου 2012


publié en ligne: 18 February 2012

Η Ελβετική φαρμακοβιομηχανία novartis συνεχίζει να μηνύει τις κυβερνήσεις αναπτυσσόμενων χωρών για τη στάση τους στη νομοθεσία για την πατέντα.

Το 1999 η Novartis μαζί με άλλες φαρμακευτικές εταιρείες μήνυσαν την κυβέρνηση της Ν. Αφρικής για τον ίδιο λόγο.

Από το 2006 μηνύουν την Ινδική κυβέρνηση για το νόμο περί πατέντας.
Η Ινδία προσφέρει γενερικά φάρμακα σε όλο τον αναπτυσσόμενο κόσμο και στους ανθρώπους με HIV/AIDS.

H Novartis δεν πέτυχε την έγκριση πατέντας για ένα αντινεοπλασματικό φάρμακο και τώρα επιτίθεται στην Ινδική κυβέρνηση.
Εάν επιτύχει, αυτό ΘΑ ΣΥΜΠΑΡΑΣΥΡΕΙ ΚΑΙ ΤΑ ΑΛΛΑ ΓΕΝΕΡΙΚΑ ΦΑΡΜΑΚΑ, ΑΡΑ ΚΑΙ ΤΑ ΦΑΡΜΑΚΑ ΓΙΑ ΤΟ HIV/AIDS.

H εταιρεία έχει χάσει την πρώτη δίκη ενάντια στην Ινδική κυβέρνηση.
Στις 28 Φεβρουαρίου το ανώτατο δικαστήριο της Ινδίας θα δικάσει την υπόθεση της Νοvartis.

Το 2011 η εταιρεία είχε πωλήσεις άνω των 54 εκ δολλαρίων.
Ενώ τα κέρδη της μεγαλώνουν μηνύει τη Ινδική κυβέρνηση.
Καθώς οι φίλοι μας στην Ινδία αγωνίζονται ομάδες σε όλο τον κόσμο θα διαδηλώνουν 22-23 Φεβρουαρίου για να στείλουν στην Novartis ένα σαφές μήνυμα:

Η επίθεση στον Ινδικό νόμο για τα γενερικά φάρμακα πρέπει να σταματήσει τώρα!

Τα φάρμακα που παράγονται στην Ινδία είναι το ίδιο αποδοτικά με εκείνα των Δυτικών χωρών.
Η δυσφήμιση των γενερικών φαρμάκων που έχουν παραχθεί και ελεγχθεί και από την WHO, εξυπηρετεί MONAXA τα κέρδη των φαρμακευτικών πολυεθνικών εταιρειών και των συνοδοιπόρων τους.

Αντιδράστε άμεσα.!
Γυρίστε κάποιο μικρό video με ένα πλακάτ με μήνυμα κατά της Novartis και στείλτε το στο mail της ACT UP BASEL actupbasel@gmail.com, προκειμένου να το ανεβάσει στο site της.


Μπορείτε επίσης να χρησιμοποιήσετε και όλα τα άλλα μέσα δικτύωσης και επικοινωνίας.
ΑΚΟΛΟΥΘΟΥΝ ΤΡΟΠΟΙ ΠΟΥ ΜΠΟΡΕΙΤΕ ΝΑ ΕΠΙΚΟΙΝΩΝΗΣΕΤΕ:
• CLICK IT: If you cannot make a video, send us your photo with your message for Novartis. (please send the photo and message to: actupbasel@gmail.com)
• SIGN IT: Avaaz is aiming to get 100,000 signatures on the Novartis Case. Sign the petition here and get everyone you know to sign too.

• TWEET IT : Join the MSF campaign and tweet your message using #STOPnovartis or take action here

• WALK IT: If there is a Novartis Office in your country, organise your own demonstrations and send them your own message.

• TALK IT: Even though you might not be able to support the demonstrations you can help us by spreading the word about the Novartis case. Write an editorial in your local paper. Hold a press conference. Issue a press release or press statement.

• SHARE IT: PLEASE send us photos, articles, videos of all your actions immediately (actupbasel@gmail.com ) and FOLLOW the actions of other groups here:

• WATCH IT: in English and in German.

• READ IT: Read about the Novartis and its US/EU surrogates triple punch to Indian generics here.
More resources at the end of this alert.


Διαβάστε το άρθρο και ενεργοποιηθείτε τώρα!!!

Swiss MultinationalPharmacuetical company Novartis is continuing its tradition of suing developing country governments for their pro-health patent laws.

In 1999, Novartis along with other pharmaceutical companies sued the South African government over pro-health amendments in their patent law.

Since 2006, they have been suing the Indian government over the health safeguards (Section 3d) in its patentlaw.
India supplies generic medicines across the developing world and health and PLHIV groups in India have been using Section 3(d) of the Indian law to ensure that key medicines stay off-patent.

Novartis did not get a patent in India on a cancer medicine and wants this law (Section 3d) weakened.

BUT THIS WILL IMPACT ALL OTHER GENERIC MEDICINES AS WELL.
Novartis is suing the Indian government and cancer patients.
It lost its first case in a lower court in India.
Now it’s before the Indian Supreme Court.
On the 28th of February 2012, the Indian Supreme Court will hear the Novartis case. Read about the case in the Background below.

48 Hours of Action: 22-23 February, 2012
On 23 February, a few days before the hearing in the Indian Supreme Court, Novartis’ shareholders are meeting in Basel at their Annual General Meeting (AGM).

In 2011, Novartis recorded more than $54 billion in sales and is one of the biggest pharmaceutical companies in profits.

While its profits are still increasing, the firm is suing the government of India.
As our friends in India gear up to fight this legal battle, groups around the world will be demonstrating on 22 and 23 February 2012 to coincide with the day of the Novartis AGM to send Novartis a clear message:
THE ATTACK ON THE INDIAN LAW AND ON GENERIC MEDICINES MUST STOP NOW!

JOIN US! WHAT can YOU DO?

• RECORD IT:
Send us a 30 second to 1 minute video—if possible holding a visual/poster against Novartis.
Record your message to Novartis or explain the consequences of the Novartis case for your life and for access to medicines in your country. Your video will be streamed on the ACTUP Basel website and will be used in demonstrations on the 22nd and 23rd of February.

Please send the video to: actupbasel@gmail.com by 21 February;

Tips: Record your video from your cell-phone or camera, upload it and΅email it to us! OR

If you have skype, write to us and we can help you record your message.

Write to actupbasel@gmail.com with your skype name if you are interested.

• CLICK IT: If you cannot make a video, send us your photo with your message for Novartis. (please send the photo and message to: actupbasel@gmail.com)
• SIGN IT: Avaaz is aiming to get 100,000 signatures on the Novartis Case. Sign the petition here and get everyone you know to sign too.

• TWEET IT : Join the MSF campaign and tweet your message using #STOPnovartis or take action here.

• WALK IT: If there is a Novartis Office in your country, organise your own demonstrations and send them your own message.

• TALK IT: Even though you might not be able to support the demonstrations you can help us by spreading the word about the Novartis case. Write an editorial in your local paper. Hold a press conference. Issue a press release or press statement.

• SHARE IT: PLEASE send us photos, articles, videos of all your actions immediately (actupbasel@gmail.com ) and FOLLOW the actions of other groups here:

• WATCH IT: in English and in German.

• READ IT: Read about the Novartis and its US/EU surrogates triple punch to Indian generics here. More resources at the end of this alert.

BACKGROUND
What is the Novartis case in India about?
Novartis patented the molecule imatinib in 1993. A
fter the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office.

In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d) an important health safeguard thatdoes not allow companies to get patents on new forms of old medicines.

Novartis’ application was rejected by the Indian patent office on several grounds including that the application claimed a new form of an already existing medicine.

The company then sued the Indian Government, cancer patients and several generic companies in order to get its patent monopoly on imatinib mesylate and wanted Section 3(d) knocked out of the patent law.

When it failed to do this in a lower court, it has now gone to the Indian Supreme Court to try and change the interpretation of Section 3(d).

In essence, Novartis wants section 3(d), which requires stringent evidence of proof of significantly enhanced therapeutic efficacy if a modification of an existing pharmaceutical entity is to receive new patent protection, to be reinterpreted to allow routine “ever-greening” of minor modifications to existing medicines resulting in additional 20-year patent monopolies.

Imatinib Mesylate: Novartis: $2500 per person per month Generics: $200 per person per month

What if Novartis wins this case?
If Novartis wins this case, the ability of India to produce cheap generic medicines will be severely affected as it will set a precedent for all future patent applications.

India is known as the ‘Pharmacy of the developing world’ for producing and supplying affordable generic drugs to more than 150 developing countries in Asia, Africa and Latin America.

In particular, India supplies nearly 80% of the medicines used to treat over seven million people living with HIV/AIDS in developing countries. India’s capacity to provide affordable drugs across all disease categories can be seriously undermined by victory of Novartis in this court case.

Novartis through its press statements, continues to assert that access to medicines is not impacted by the granting of patent for a new medicine.
The company stresses that it is simply about availability of medicines not affordability.
But they are wrong.
In the ordinary course of events, obtaining a patent gives the right holder authority to exclude others from making the patented product or using a patented process hat right toexclude in turns gives rise to monopoly pricing power, especially in the pharmaceutical contexts.

Big Pharma companies price their medicines at exorbitant rates catering only to elite group to make more profits instead of selling larger quantities at lower prices that poor people and poor countries might afford.

In economic jargon, these excluded patients are called a dead-weight cost – in the real world, they are merely called dead.

Resources on the Novartis Case
Lawyers Collective
Cancer Patients Aid Association
Berne Declaration
Act-Up basel
Health Gap
Oxfam
MSF
Treatment Action Campaign
Novartis Boycott