Background: "European Union lawmakers reached agreement in December over a new Clinical Trials Regulation, which replaces a 2001 directive. Under the agreement, pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database. A publicly accessible EU database will be set up and run […]
Smoke This: Pfizer Wants Serious Warnings Removed From Chantix Pharmalot: WSJ By Ed Silverman September 24, 2014 In a boost to Pfizer, the FDA has updated labeling on its Chantix smoking-cessation pill to indicate the drug may not carry the risks of suicidal behavior, a controversial issue that prompted the agency to include a serious […]
The meeting when the EMA will deliver their formal policy for Data Transparency is just a week away. Earlier, I’ve mentioned my apprehension about what they might say [the other shoe…] and given an outline of the kind of data that might be involved [it matters…]. Several of years ago, I was pointed to some […]
Adverse Events Caused by a Drug Warning? Medscape Psychiatry by Robert L. Findling, MD July 31, 2014 "Hello. I’m Dr. Robert Findling, Director of the Division of Child and Adolescent Psychiatry at Johns Hopkins University and a vice president at the Kennedy Krieger Institute in Baltimore. The US Food and Drug Administration [FDA] issued a warning in […]
"So what we wanted to do is to find a diagnostic test that can be done in any clinical laboratory whereby a patient can go to the doctor and the doctor can send blood to the clinical laboratory that can help the physician to decide if the patient is clinically depressed or not. It will […]
EU agency lifts lid on drug data secrets Reuters By Ben Hirschler July 15, 2012 Europe’s medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information.The change is a landmark in […]
Glaxo Found Guilty of Bribery in China: Can Witty Rehabilitate the Drug Maker? Pharmalot: WSJ by Ed Silverman September 19, 2014 After months of anticipation, a Chinese court found the GlaxoSmithKline subsidiary in China guilty of bribing doctors, hospital officials and other non-government personnel, and fined the drug maker more than $490 million, The Wall […]
It looks as if the Windy City of Chicago is taking the lead in figuring out if people are depressed without even asking them. Dr. Robert Gibbons of the University of Chicago is planning an an iPhone App that lets the cloud figure it out [insider trading…], and now Dr. Eva Redei of Northwestern’s Feinberg […]
One of the great lessons of psychotherapy is the importance of formulating good questions along the way, even though the answers are often not available for a while. If the question is already on the table, when the answer happens to come along, you don’t miss it. It’s like finding that last piece of a […]