Johns Hopkins is launching a new Center for Drug Safety and Effectiveness. Via G. Caleb
On Wednesday, October 24, we will launch the Johns Hopkins Center for Drug Safety and Effectiveness, a collaborative effort of the Bloomberg School of Public Health and Johns Hopkins Medicine. The Center will fulfill its mission by supporting individuals engaged in research, training, clinical programs and public service to optimize the safe and effective use of prescription medicines in the United States and around the world.
We are delighted that Dr. Mark McClellan will deliver the inaugural lecture for the Center on October 24 at 4:00 PM, with a reception to follow.
See my previous post on the need for data sharing. For the past three years, a group of researchers has been trying to gather all of the clinical trial data for the anti-influenza drug Tamiflu (oseltamivir), without success. As a result there is continuing uncertainty about the benefits — and harms — of the drug. They tell their story in a New York Times op-ed and an article in PLoS Medicine. Here is the summary from the PLoS Medicine article:
- Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.
- More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators.
- Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers.
- We propose clinical study reports become available to such scrutiny, and describe one manufacturer’s unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.
Also in PLoS Medicine, a response by a group of European drug regulators. The regulators agree that that data secrecy is no longer acceptable but list some reasons for caution.
Peter Doshi and Tom Jefferson, “Drug Data Shouldn’t Be Secret,” New York Times, April 10, 2012.
Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201. doi:10.1371/journal.pmed.1001201
Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open Clinical Trial Data for All? A View from Regulators. PLoS Med 9(4): e1001202. doi:10.1371/journal.pmed.1001202
Here is a summary from Pharmalot.
The ABIM Foundation has joined with nine medical specialty societies to develop evidence-based lists of tests and procedures for patients and physicians to discuss and question. The goal of Choosing Wisely is to help physicians, patients and other stakeholders avoid unnecessary and in some cases harmful interventions and reduce the ever-expanding cost of health care. Each participating specialty society will identify five tests or procedures whose use should be questioned. The lists will be announced in April 2012. The lists are modeled after the National Physicians Alliance project “Five Things You Can Do in Your Practice,” which was funded by the ABIM Foundation. Consumer Reports will also be participating in the campaign. One page factsheet here. Press Release here. Website here.
David Rind recently revived his blog Evidence in Medicine and has a post up on the SHARP trial. The SHARP trial, which I discussed recently on this blog and on Gooznews, is the basis for Merck’s application for a new indication for its drugs Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe). David explains why the results in SHARP are consistent with previous evidence on the effect of statins in patients with chronic kidney disease, both pre-dialysis and on dialysis.
Kevin Lomangino has an article up on the “portfolio diet,” which is a diet that emphasizes foods that lower cholesterol. Kevin explains that most of the cholesterol-lowering from this diet comes from the inclusion of foods containing added plant sterols. As I previously discussed on this blog, while plant sterols lower LDL, their effect on cardiovascular events is unknown, making the portfolio diet a bit of a crapshoot healthwise.