Fears have been raised over the safety of a cervical cancer vaccine which health officials plan to give all 12-year-old girls, after it was revealed that the drug has been linked to several deaths.
Three young women are reported to have died days after the drug Gardasil was administered, while the jab is also suspected of triggering "adverse reactions" in 1,700 patients. The figures were uncovered by campaigners who made a freedom of information request in the US, where the vaccine was approved for use a year ago.
Tom Fitton, the president of Judicial Watch, which extracted the data, said: "Reports on the vaccine read like a catalogue of horrors."
The women – aged 12, 19 and 22 – suffered heart attacks or blood clots after being injected with Gardasil, which protects against the sexually transmitted human papilloma virus which causes most cases of cervical cancer. Hundreds of others reported suffering what could be adverse reactions, including paralysis, seizures and miscarriages.
The news comes just days after the announcement that the drug would be added to the childhood immunisation programme.
However, it has not been conclusively proven that Gardasil had directly caused any of the deaths or reported health problems.
Nicholas Kitchin, from Gardasil, manufacturers Sanofi Pasteur MSD, said the fact that symptoms were reported after a vaccination did not necessarily mean they were caused by the vaccine.
A spokesman for the Medicines and Healthcare products Regulatory Agency said no "proven, serious new risks have been identified", but added the effects would be monitored when Gardasil is used in the UK.
Jackie Fletcher, from the vaccine damage support group Jabs, said: "Trials of this jab have mostly been on adults, so we don't have any idea of the long-term effect on children."
Dr John Oakley, a West Midlands GP, said the trials for Gardasil had been so limited that the children taking it would be like "guinea pigs".
Many health campaigners have welcomed the plan to vaccinate British girls, although there have been claims it will encourage teenagers to have sex early.
Source: Telegraph.co.uk
Sunday, November 4, 2007
Temodar and radiation extends survival
NEW YORK, Oct 29 (Reuters) - Four times as many brain cancer patients who received Schering-Plough Corp (SGP.N: Quote, Profile, Research) drug Temodar and radiation were still alive four years after being diagnosed than those who received radiation alone, researchers said on Monday.
The data come from continued observation of patients from a Phase III study whose results appeared in 2005. That 573- patient study showed twice as many patients treated with Temodar and radiation survived two years after diagnosis as those receiving only radiation.
The patients were treated for a rapidly fatal form of brain cancer called glioblastoma multiforme (GBM), which accounts for up to 25 percent of all primary brain tumors.
The follow-up analysis described on Monday showed that 12 percent of those receiving Temodar during and after radiation lived for four years, versus three percent of those receiving radiation alone.
Researchers also noted that patients who survived for four years after being diagnosed were primarily younger than 50 and in otherwise good health, meaning no prior major medical condition.
About 28 percent of such otherwise healthy and relatively young patients treated with Temodar and radiation lived for four years, compared with 7 percent of those who received only radiation.
"Since GBM patients can now live longer, oncologists are monitoring them more closely and a substantial proportion of these patients are being actively treated when their cancer returns, through a combination of treatment options," said Rene-Olivier Mirimanoff, lead author of the study and a radiation oncologist at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.
The four-year follow-up data were presented in Los Angeles at a meeting of the American Society for Therapeutic Radiology and Oncology.
Source: Reuter.com
The data come from continued observation of patients from a Phase III study whose results appeared in 2005. That 573- patient study showed twice as many patients treated with Temodar and radiation survived two years after diagnosis as those receiving only radiation.
The patients were treated for a rapidly fatal form of brain cancer called glioblastoma multiforme (GBM), which accounts for up to 25 percent of all primary brain tumors.
The follow-up analysis described on Monday showed that 12 percent of those receiving Temodar during and after radiation lived for four years, versus three percent of those receiving radiation alone.
Researchers also noted that patients who survived for four years after being diagnosed were primarily younger than 50 and in otherwise good health, meaning no prior major medical condition.
About 28 percent of such otherwise healthy and relatively young patients treated with Temodar and radiation lived for four years, compared with 7 percent of those who received only radiation.
"Since GBM patients can now live longer, oncologists are monitoring them more closely and a substantial proportion of these patients are being actively treated when their cancer returns, through a combination of treatment options," said Rene-Olivier Mirimanoff, lead author of the study and a radiation oncologist at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.
The four-year follow-up data were presented in Los Angeles at a meeting of the American Society for Therapeutic Radiology and Oncology.
Source: Reuter.com
FDA OKs Novartis Cancer Drug
Novartis (NVS - Cramer's Take - Stockpickr - Rating) said Monday afternoon that the Food and Drug Administration approved its second-line treatment for chronic myeloid leukemia (CML), a life-threatening blood cancer that's one of the four most common types of leukemia.
The FDA approved Tasigna for adults with Philadelphia chromosome-positive (Ph+) CML who are resistant or intolerant to prior treatment, including Novartis' Glivec.
Novartis said it will make the twice-daily drug available in the U.S. within days. It was approved in Switzerland in July 2007, and Novartis expects an approval in the European Union by the end of this year. The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September recommending the drug be approved. Tasigna was also submitted for approval in Japan in June.
Source: TheStreet.com
The FDA approved Tasigna for adults with Philadelphia chromosome-positive (Ph+) CML who are resistant or intolerant to prior treatment, including Novartis' Glivec.
Novartis said it will make the twice-daily drug available in the U.S. within days. It was approved in Switzerland in July 2007, and Novartis expects an approval in the European Union by the end of this year. The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September recommending the drug be approved. Tasigna was also submitted for approval in Japan in June.
Source: TheStreet.com
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