First-line temsirolimus improves survival in advanced renal cell carcinoma
American researchers have reported increased survival with temsirolimus (Torisel) compared with the standard treatment for this disease, interferon alpha, in patients with advanced renal cell carcinoma (RCC), in a study published today in The New England Journal of Medicine.
In this multicenter, phase III trial, 626 patients with previously untreated, advanced RCC received either temsirolimus, interferon alpha, or both as combination therapy.
Overall survival and progression-free were significantly longer in patients receiving temsirolimus, compared with patients receiving interferon alone. There was no significant difference in overall survival between patients in the interferon group versus the combination therapy group. In addition, there were significantly fewer serious adverse events in the tesirolimus group versus the interferon alpha group.
Author’s conclusions: ‘As compared with interferon alfa, temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis. The addition of temsirolimus to interferon did not improve survival.’
Note: Wyeth filed an application with the U.S. Food and Drug Administration in November 2006 for approval to market temsirolimus for the treatment of advanced renal cell carcinoma. A decision is expected shortly (July 2007).
Source: http://content.nejm.org/cgi/content/short/356/22/2271
Thursday, May 31, 2007
Wednesday, May 30, 2007
No benefits for clodronate in prostate cancer
UK researchers have reported no benefits with the bisphosphonate, clodronate, in non-metastatic prostate cancer in terms of overall or bone-metastasis-free surivival, in a study published today in the Journal of the National Cancer Institute.
In this randomized–controlled trial, there was no significant difference in bone-metastases-free survival or overall survival between clodronate or placebo over 10 years in men with nonmetastatic prostate cancer who were at high risk of developing bone metastases.
This study was initiated because of evidence suggesting that adjuvant bisphosphonates may reduce the rate of development of bone metastases-negative breast cancer, but it was not known whether they had similar effects in prostate cancer.
Author’s conclusions: ‘adjuvant sodium clodronate does not modify the natural history of nonmetastatic prostate cancer’.
Source: http://jnci.oxfordjournals.org/cgi/content/full/99/10/765
UK researchers have reported no benefits with the bisphosphonate, clodronate, in non-metastatic prostate cancer in terms of overall or bone-metastasis-free surivival, in a study published today in the Journal of the National Cancer Institute.
In this randomized–controlled trial, there was no significant difference in bone-metastases-free survival or overall survival between clodronate or placebo over 10 years in men with nonmetastatic prostate cancer who were at high risk of developing bone metastases.
This study was initiated because of evidence suggesting that adjuvant bisphosphonates may reduce the rate of development of bone metastases-negative breast cancer, but it was not known whether they had similar effects in prostate cancer.
Author’s conclusions: ‘adjuvant sodium clodronate does not modify the natural history of nonmetastatic prostate cancer’.
Source: http://jnci.oxfordjournals.org/cgi/content/full/99/10/765
Tuesday, May 29, 2007
Internet monitoring by Pharma companies
GlaxoSmithKline, Pfizer, and Johnson & Johnson are considering the use of proprietary computer software to monitor blogs, news groups, and patient online forums for mention of the companies' pharmaceutical products in internet postings. Please see Tom's blog for further detail.
Source: http://www.drug-injury.com/druginjurycom/2005/06/drug_manufactur.html#comments
GlaxoSmithKline, Pfizer, and Johnson & Johnson are considering the use of proprietary computer software to monitor blogs, news groups, and patient online forums for mention of the companies' pharmaceutical products in internet postings. Please see Tom's blog for further detail.
Source: http://www.drug-injury.com/druginjurycom/2005/06/drug_manufactur.html#comments
Controversy over the cardiovascular risks of Avandia for Type 2 diabetes
A controversial study reporting that rosiglitazone (Avandia) increases the risk of a myocardial infarction and death from cardiovascular disease was published last week in the journal The New England Journal of Medicine.
In this study, the authors combined the results from 42 randomized-controlled clinical trials. Each study had to last for more than six months, include a control group other than Avandia, and include outcomes data on data myocardial infactions and deaths from cardiovascular disease. The authors reported that Avandia increased the risk of a myocardial infarction by 43% and the risk of death from cardiovascular causes by 64%.
The authors noted that this study had several limitations: 1) results were pooled from trials that were not intended to explore cardiovascular outcomes, 2) definitions of a myocardial infarction were not available, 3) many of the trials were small and of short duration, and as a result there were few adverse cardiovascular events or deaths. As a result, getting to the nittry gritty statistical stuff (switch off now if you want to), the confidence intervals for the odds ratios were wide, causing uncertainty on the magnitude of the harmful effect of Avandia.
Not surprisingly, GSK shares plummeted by 8% on the day that this paper was released on-line. But, GSK’s problems didn’t stop there. The FDA released safety alert for Avandia and advised patients who take it to consult their doctors (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html). In this report, the FDA mention that GSK provided them with a meta-analysis of 42 studies, which according to the FDA ‘suggested that patients receiving short-term treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy.’
Even worse, the medical director at GSK, has reported that 4,450 patients enrolled in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial, which aims to evaluate the long-term risk of Avandia and other rosiglitazones, have dropped out this week because of these safety concerns.(http://www.nytimes.com/2007/05/26/business/26drug.html). This could result in the trial being stopped early if the target number of patients cannot be reached. This could mean trouble for GSK as the results of this study, if they are positive, would have helped to allay any fears regarding Avandia.
Finally, I note with some amusement that the lead author on the study, Dr Nissen, discloses his affiliation with several pharmaceutical companies, some of whom have competitor products to Avandia, notably Eli-Lilly and Takeda who produce Actos (pioglitazone) also for type 2 diabetes (see the disclosure stament from Dr Nissen below). One has to wonder whether any inherent bias has creeped into this meta-analysis when Dr Nissen was performing his review of the clinical trials. Perhaps it should have been performed by an independent body?
‘Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. No other potential conflict of interest relevant to this article was reported.‘
Source: http://content.nejm.org/cgi/content/full/NEJMoa072761
A controversial study reporting that rosiglitazone (Avandia) increases the risk of a myocardial infarction and death from cardiovascular disease was published last week in the journal The New England Journal of Medicine.
In this study, the authors combined the results from 42 randomized-controlled clinical trials. Each study had to last for more than six months, include a control group other than Avandia, and include outcomes data on data myocardial infactions and deaths from cardiovascular disease. The authors reported that Avandia increased the risk of a myocardial infarction by 43% and the risk of death from cardiovascular causes by 64%.
The authors noted that this study had several limitations: 1) results were pooled from trials that were not intended to explore cardiovascular outcomes, 2) definitions of a myocardial infarction were not available, 3) many of the trials were small and of short duration, and as a result there were few adverse cardiovascular events or deaths. As a result, getting to the nittry gritty statistical stuff (switch off now if you want to), the confidence intervals for the odds ratios were wide, causing uncertainty on the magnitude of the harmful effect of Avandia.
Not surprisingly, GSK shares plummeted by 8% on the day that this paper was released on-line. But, GSK’s problems didn’t stop there. The FDA released safety alert for Avandia and advised patients who take it to consult their doctors (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html). In this report, the FDA mention that GSK provided them with a meta-analysis of 42 studies, which according to the FDA ‘suggested that patients receiving short-term treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy.’
Even worse, the medical director at GSK, has reported that 4,450 patients enrolled in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial, which aims to evaluate the long-term risk of Avandia and other rosiglitazones, have dropped out this week because of these safety concerns.(http://www.nytimes.com/2007/05/26/business/26drug.html). This could result in the trial being stopped early if the target number of patients cannot be reached. This could mean trouble for GSK as the results of this study, if they are positive, would have helped to allay any fears regarding Avandia.
Finally, I note with some amusement that the lead author on the study, Dr Nissen, discloses his affiliation with several pharmaceutical companies, some of whom have competitor products to Avandia, notably Eli-Lilly and Takeda who produce Actos (pioglitazone) also for type 2 diabetes (see the disclosure stament from Dr Nissen below). One has to wonder whether any inherent bias has creeped into this meta-analysis when Dr Nissen was performing his review of the clinical trials. Perhaps it should have been performed by an independent body?
‘Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. No other potential conflict of interest relevant to this article was reported.‘
Source: http://content.nejm.org/cgi/content/full/NEJMoa072761
Monday, May 28, 2007
Calcium and Vitamin D associated with lower risk of breast cancer in pre-menopausal women
American scientists have found that women who consume higher amounts of calcium and vitamin D may have a lower risk of developing premenopausal breast cancer, in research published in the journal Archives of Internal Medicine.
In this study, researchers prospectively evaluated calcium and vitamin D intake and breast cancer incidence among approximately 11,000 premenopausal and approximately 21,000 postmenopausal women 45 years or older who were free of cancer and cardiovascular disease at the start of the study.
Over an average of 10 years, higher intakes of total calcium and vitamin D were moderately associated with a lower risk of breast cancer in premenopausal women.
Author’s conclusions: ‘Higher intakes of calcium and vitamin D may be associated with a lower risk of developing premenopausal breast cancer.’
American scientists have found that women who consume higher amounts of calcium and vitamin D may have a lower risk of developing premenopausal breast cancer, in research published in the journal Archives of Internal Medicine.
In this study, researchers prospectively evaluated calcium and vitamin D intake and breast cancer incidence among approximately 11,000 premenopausal and approximately 21,000 postmenopausal women 45 years or older who were free of cancer and cardiovascular disease at the start of the study.
Over an average of 10 years, higher intakes of total calcium and vitamin D were moderately associated with a lower risk of breast cancer in premenopausal women.
Author’s conclusions: ‘Higher intakes of calcium and vitamin D may be associated with a lower risk of developing premenopausal breast cancer.’
Sunday, May 27, 2007
No association between regular multivitamin use and risk of prostate cancer, but increased risk with excessive use
American researchers have found no association between regular multivitamin use (up to seven times per week) and risk of prostate cancer. However, they did find an association between excessive multivitamin use (more than seven times a week) and risk of prostate cancer. The positive association between excessive multivitamin use and risk of prostate cancer were strongest in men with a family history of prostate cancer or who were also taking individual selenium, beta-carotene, or zinc supplements.
Authors conclusions ‘Regular multivitamin use is not associated with the risk of early or localized prostate cancer. The possibility that men taking high levels of multivitamins along with other supplements have increased risk of advanced and fatal prostate cancers is of concern and merits further evaluation.’
Source: http://jnci.oxfordjournals.org/cgi/content/full/99/10/754#TBL5
American researchers have found no association between regular multivitamin use (up to seven times per week) and risk of prostate cancer. However, they did find an association between excessive multivitamin use (more than seven times a week) and risk of prostate cancer. The positive association between excessive multivitamin use and risk of prostate cancer were strongest in men with a family history of prostate cancer or who were also taking individual selenium, beta-carotene, or zinc supplements.
Authors conclusions ‘Regular multivitamin use is not associated with the risk of early or localized prostate cancer. The possibility that men taking high levels of multivitamins along with other supplements have increased risk of advanced and fatal prostate cancers is of concern and merits further evaluation.’
Source: http://jnci.oxfordjournals.org/cgi/content/full/99/10/754#TBL5
Saturday, May 26, 2007
Eltrombopag, being developed by GSK for thrombocytopenia, demonstrates encouraging Phase I results
Eltrombopag is the first in a new class of oral, small-molecule, non-peptide agonist of the thrombopoietin receptor, being developed by GSK for the treatment of thrombocytopenia (low platelet count) due to various causes. Results published in the journal Blood suggest that suggest that the pharmacodynamic, pharmacokinetic, and safety profile of eltrombopag supports further investigation in Phase II trials.
In this Phase I placebo-controlled trial, eltrombopag was given to 73 healthy male volunteers as once-daily oral capsules for 10 days at doses ranging from 5 to 75 mg. Increases in platelet counts were seen at 30, 50 and 75 mg doses of eltrombopag, and started rising at Day 5 of treatment and peaking on Day 15. The pharmacokinetics of eltrombopag were dose dependent and linear, and platelet counts increased in a dose-dependent manner. There were no apparent differences in the incidence of adverse events between volunteers in the eltrombopag or placebo groups.
The authors conclude ‘These observations indicate that eltrombopag is a once-daily, oral Thrombopoietin receptor agonist with demonstrated thrombopoietic activity in human subjects, encouraging further studies in patients with thrombocytopenia.’
Source: http://bloodjournal.hematologylibrary.org/
NOTE: GSK seem to be investigating the use of Eltrombopag in various indications, including patients with idiopathic thrombocytopenic purpura and patients with low platelet counts who are receiving chemotherapy with Adriamycin and Ifosfamide.
Eltrombopag is the first in a new class of oral, small-molecule, non-peptide agonist of the thrombopoietin receptor, being developed by GSK for the treatment of thrombocytopenia (low platelet count) due to various causes. Results published in the journal Blood suggest that suggest that the pharmacodynamic, pharmacokinetic, and safety profile of eltrombopag supports further investigation in Phase II trials.
In this Phase I placebo-controlled trial, eltrombopag was given to 73 healthy male volunteers as once-daily oral capsules for 10 days at doses ranging from 5 to 75 mg. Increases in platelet counts were seen at 30, 50 and 75 mg doses of eltrombopag, and started rising at Day 5 of treatment and peaking on Day 15. The pharmacokinetics of eltrombopag were dose dependent and linear, and platelet counts increased in a dose-dependent manner. There were no apparent differences in the incidence of adverse events between volunteers in the eltrombopag or placebo groups.
The authors conclude ‘These observations indicate that eltrombopag is a once-daily, oral Thrombopoietin receptor agonist with demonstrated thrombopoietic activity in human subjects, encouraging further studies in patients with thrombocytopenia.’
Source: http://bloodjournal.hematologylibrary.org/
NOTE: GSK seem to be investigating the use of Eltrombopag in various indications, including patients with idiopathic thrombocytopenic purpura and patients with low platelet counts who are receiving chemotherapy with Adriamycin and Ifosfamide.
Friday, May 25, 2007
Some Cancers Linked To Very Low Frequency Electromagnetic Fields
Some cancers, notably myeloid leukemia and Hodgkin’s lymphoma, could be linked to extremely low frequency electromagnetic fields, suggests research published in the journal of Occupational and Environmental Medicine.
In this study, researchers, retrospectively checked the records of 20,141 retired or employed Swiss railway workers between 1972 and 2002. They reported no link between electromagnetic field exposure and deaths from lymphoid leukaemia, non-Hodgkin's lymphoma and brain tumours. However, there was some evidence that higher levels of electromagnetic field exposure increased the rates of myeloid leukaemia and Hodgkin's lymphoma. Drivers were more than four times as likely to die of myeloid leukaemia, and over three times as likely to die of Hodgkin's lymphoma, as station masters.
The authors conclude ‘We found some evidence of an exposure-response association for myeloid leukaemia and Hodgkin's disease, but not for other haematopoietic and lymphatic malignancies and brain tumours’.
Source: http://oem.bmj.com/cgi/content/abstract/oem.2006.030270v1
Some cancers, notably myeloid leukemia and Hodgkin’s lymphoma, could be linked to extremely low frequency electromagnetic fields, suggests research published in the journal of Occupational and Environmental Medicine.
In this study, researchers, retrospectively checked the records of 20,141 retired or employed Swiss railway workers between 1972 and 2002. They reported no link between electromagnetic field exposure and deaths from lymphoid leukaemia, non-Hodgkin's lymphoma and brain tumours. However, there was some evidence that higher levels of electromagnetic field exposure increased the rates of myeloid leukaemia and Hodgkin's lymphoma. Drivers were more than four times as likely to die of myeloid leukaemia, and over three times as likely to die of Hodgkin's lymphoma, as station masters.
The authors conclude ‘We found some evidence of an exposure-response association for myeloid leukaemia and Hodgkin's disease, but not for other haematopoietic and lymphatic malignancies and brain tumours’.
Source: http://oem.bmj.com/cgi/content/abstract/oem.2006.030270v1
Thursday, May 24, 2007
Liquid-based cytology just as sensitive as conventional cytology in cervical cancer screening
Despite falling incidence, cervical cancer remains the tenth leading cause of cancer death. However, cervical screening programmes have been shown to reduce the incidence of this type of cancer.
Liquid based cytology (LBC) is a new way of preparing cervical samples for examination in the laboratory, which involves scraping the sample into a vial of liquid, compared with conventional cytology were the sample is scraped onto a miscroscope slide. In both instances, the prepared sample is examined under a microscope with the aim of detecting any malignant cells. Previous studies comparing the accuracy of both of these techniques have produced conflicting results.
In this study of approximately 45, 0000 women in Italy, the authors reported no significant difference in diagnostic sensitivity between LBC and conventional cytology.
The authors conclude that although there is no difference is sensitivity between the two techniques, the main advantage of LBC is that it reduces the number of unsatisfactory slides that are usually difficult to interpret.
Source: http://www.bmj.com/cgi/rapidpdf/bmj.39196.740995.BEv1
Despite falling incidence, cervical cancer remains the tenth leading cause of cancer death. However, cervical screening programmes have been shown to reduce the incidence of this type of cancer.
Liquid based cytology (LBC) is a new way of preparing cervical samples for examination in the laboratory, which involves scraping the sample into a vial of liquid, compared with conventional cytology were the sample is scraped onto a miscroscope slide. In both instances, the prepared sample is examined under a microscope with the aim of detecting any malignant cells. Previous studies comparing the accuracy of both of these techniques have produced conflicting results.
In this study of approximately 45, 0000 women in Italy, the authors reported no significant difference in diagnostic sensitivity between LBC and conventional cytology.
The authors conclude that although there is no difference is sensitivity between the two techniques, the main advantage of LBC is that it reduces the number of unsatisfactory slides that are usually difficult to interpret.
Source: http://www.bmj.com/cgi/rapidpdf/bmj.39196.740995.BEv1
Physicians competent in colonoscopies after performing 150 procedures
Colonoscopies are considered the gold standard for detecting colon cancer, the second leading cause of cancer deaths in the United States. Research presented this week at Digestive Disease Week 2007 (DDW) reported that for a physician to be competent in colonoscopy they have to complete more than 150 procedures.
In this study of colonoscopies performed by 24 first-year fellows in 15 centres, the success rate was determined by the completion rate and the cecal intubation time (the time to insert a tube into the first part of the bowel). The success rate was significantly improved and reached the competency standard after 150 procedures. For example, after 150 procedures the cecal intubation time decreased from 14.2 to 9 mins.
Colonoscopies are considered the gold standard for detecting colon cancer, the second leading cause of cancer deaths in the United States. Research presented this week at Digestive Disease Week 2007 (DDW) reported that for a physician to be competent in colonoscopy they have to complete more than 150 procedures.
In this study of colonoscopies performed by 24 first-year fellows in 15 centres, the success rate was determined by the completion rate and the cecal intubation time (the time to insert a tube into the first part of the bowel). The success rate was significantly improved and reached the competency standard after 150 procedures. For example, after 150 procedures the cecal intubation time decreased from 14.2 to 9 mins.
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