Richmond Pharmacology update
Here is a quick note about yesterday's hearing. Judgment is expected next week. The judge grasped the importance of trial registration and when he took into account our and the HRA's evidence on legal and ethical obligations to register trials he found that Richmond was left with an extraordinarily narrow argument. It seems the case will come down to some words in a Q&A on HRA's website that wasn't amended at the same time as the sponsors' declaration was. And then whether the ambiguity was significant.We are so pleased we decided to intervene in the case. The court could find for Richmond on this very narrow...
Source: PharmaGossip - July 19, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Further Update
Hi AllTrials friendsYesterday we sent our submission to the court in the judicial review brought against the HRA by Richmond Pharmacology.We have spent the last few weeks ploughing through the hundreds of pages of documents. Richmond is currently asking the judge to rule that there is no overriding legal requirement to publicly register any trial. That ’s not correct. Since 2011 all trials except for adult phase 1 have been publicly registered through the EU Clinical Trials Register. And by next year this legal requirement will extend to all clinical trials unless exempted according to some very tight criteria. Richmond ...
Source: PharmaGossip - July 8, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Further Update
Hi AllTrials friendsYesterday we sent our submission to the court in the judicial review brought against the HRA by Richmond Pharmacology.We have spent the last few weeks ploughing through the hundreds of pages of documents. Richmond is currently asking the judge to rule that there is no overriding legal requirement to publicly register any trial. That’s not correct. Since 2011 all trials except for adult phase 1 have been publicly registered through the EU Clinical Trials Register. And by next year this legal requirement will extend to all clinical trials unless exempted according to some very tight criteria. Richmond i...
Source: PharmaGossip - July 7, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
AllTrials vs Richmond Pharmacology
Dear AllTrials friendWe hoped to tell you more about the case Richmond Pharmacology is bringing against the HRA. That's not been straightforward. Richmond has now changed their argument three times and has altogether abandoned some arguments it relied upon earlier, so getting to grips with what is at stake has been difficult and time consuming for us and for our lawyers.At the beginning of this week it looked as though Richmond had narrowed the case down to a technical argument about the wording of HRA ’s guidelines which only applied for a period of 10 days earlier this year.Just as the issues seemed to be narrowing, Ri...
Source: PharmaGossip - June 25, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
AllTrials vs Richmond Pharmacology
Dear AllTrials friendWe hoped to tell you more about the case Richmond Pharmacology is bringing against the HRA. That's not been straightforward. Richmond has now changed their argument three times and has altogether abandoned some arguments it relied upon earlier, so getting to grips with what is at stake has been difficult and time consuming for us and for our lawyers.At the beginning of this week it looked as though Richmond had narrowed the case down to a technical argument about the wording of HRA’s guidelines which only applied for a period of 10 days earlier this year.Just as the issues seemed to be narrowing, Ric...
Source: PharmaGossip - June 24, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Ben Goldacre writes in the BMJ - How medicine is broken, and how we can fix it
The chief medical officer ’s review on statins and oseltamivir may look for answers in the wrong placesLast week there was extensive news coverage of a leaked letter written by the chief medical officer to the Academy of Medical Sciences. This letter focused especially on concerns around statins and oseltamivir (Tamiflu) and asked the academy for an “authoritative independent report looking at how society should judge the safety and efficacy of drugs.”1 The academy has since announced that it is convening a working group on the subject.With any such report there are two major risks. The first is a focus on “trust...
Source: PharmaGossip - June 23, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Ben Goldacre writes in the BMJ - How medicine is broken, and how we can fix it
The chief medical officer’s review on statins and oseltamivir may look for answers in the wrong placesLast week there was extensive news coverage of a leaked letter written by the chief medical officer to the Academy of Medical Sciences. This letter focused especially on concerns around statins and oseltamivir (Tamiflu) and asked the academy for an “authoritative independent report looking at how society should judge the safety and efficacy of drugs.”1 The academy has since announced that it is convening a working group on the subject.With any such report there are two major risks. The first is a focus on “trust”...
Source: PharmaGossip - June 22, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
A message from AllTrials about Richmond Pharmacology's Judicial Review
Dear AllTrials friendAs most of you know Richmond Pharmacology has brought a judicial review against the Health Research Authority because it insists on the registration (not even reporting, but registration) of clinical trials. Read more.This is a quick note to let you know that we have obtained the court papers (hundreds of them!), we are looking urgently with lawyers at what can be done and we will be in touch next week to tell you. In the meantime, if you have been meaning to help with our campaign fund, now would be a great time... And if you can help with time over July, please tell us by replying...
Source: PharmaGossip - June 12, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
A message from AllTrials about Richmond Pharmacology's Judicial Review
Dear AllTrials friendAs most of you know Richmond Pharmacology has brought a judicial review against the Health Research Authority because it insists on the registration (not even reporting, but registration) of clinical trials. Read more.This is a quick note to let you know that we have obtained the court papers (hundreds of them!), we are looking urgently with lawyers at what can be done and we will be in touch next week to tell you. In the meantime, if you have been meaning to help with our campaign fund, now would be a great time... And if you can help with time over July, please tell us by replyin...
Source: PharmaGossip - June 11, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial reporting: betraying trial participants, harming patients
Reporting biases found in trials of cardiovascular devicesReporting biases in published trials were first identified in 1986.1 Published randomized studies of combination chemotherapy compared with treatment with an alkylating agent as first line treatment for ovarian cancer showed a significant survival advantage for combination chemotherapy. Unpublished cancer trial registry data from the same studies, however, showed no such advantage.2 Similarly, in the treatment of multiple myeloma, registry data suggested a smaller survival advantage for combination chemotherapy (over prednisone and an alkylating agent) tha...
Source: PharmaGossip - June 11, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial
reporting: betraying trial participants, harming patients
Reporting biases found in trials of cardiovascular devicesReporting biases in published trials were first identified in 1986.1 Published randomized studies of combination chemotherapy compared with treatment with an alkylating agent as first line treatment for ovarian cancer showed a significant survival advantage for combination chemotherapy. Unpublished cancer trial registry data from the same studies, however, showed no such advantage.2 Similarly, in the treatment of multiple myeloma, registry data suggested a smaller survival advantage for combination chemotherapy (over prednisone and an alkylating agent) tha...
Source: PharmaGossip - June 11, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial
reporting: betraying trial participants, harming patients
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Source: PharmaGossip - June 10, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial
reporting: betraying trial participants, harming patients
Reporting biases found in trials of cardiovascular devicesReporting biases in published trials were first identified in 1986.1 Published randomized studies of combination chemotherapy compared with treatment with an alkylating agent as first line treatment for ovarian cancer showed a significant survival advantage for combination chemotherapy. Unpublished cancer trial registry data from the same studies, however, showed no such advantage.2 Similarly, in the treatment of multiple myeloma, registry data suggested a smaller survival advantage for combination chemotherapy (over prednisone and an alkylating agent) tha...
Source: PharmaGossip - June 10, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Introducing GlobalLeaks
https://globaleaks.org/GlobaLeaks is an open source project aimed at creating a worldwide, anonymous, censorship-resistant, distributed whistleblowing platform. (Source: PharmaGossip)
Source: PharmaGossip - May 26, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
