Author Archives: Ivan Oransky, M.D.

Ivan Oransky, M.D.

About Ivan Oransky, M.D.

Ivan Oransky, M.D., president of AHCJ's board of directors, is vice president, editorial, at Medscape and a Distinguished Writer In Residence at New York University’s Arthur L. Carter Journalism Institute. He blogs at Embargo Watch and at Retraction Watch. Follow him at @IvanOransky.

President’s Corner: Issues worth keeping in mind as we head into 2020 elections

When it comes to debates over health care policy, there are a number of terms that make veteran reporter Joanne Kenen roll her eyes.

There’s “access,” for example. “Saying you have access doesn’t mean you can really tap into that ‘access,’” says Kenen, executive editor for health at Politico and health reform topic leader for AHCJ. “If I have access to something that costs $25,000, that’s not really access. Who is this protecting and what does this really mean?” In other words, Kenen says, “access means whatever you want it to mean.” Continue reading

AHCJ members contribute tips on best uses of ClinicalTrials.gov

Medical reporters are likely familiar with ClinicalTrials.gov, the U.S. government-run registry of clinical trials. The site became available in 2000, three years after Congress passed the Food and Drug Administration Modernization Act of 1997 (FDAMA), which, as the site notes,

required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications (IND) to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.

The site – and others around the world – really took off in 2005 after the International Committee of Medical Journal Editors began requiring that researchers register their trials when they started if they wanted to publish the results. Publishing in the peer-reviewed literature is the coin of the realm in academia and also vital for FDA approval, so the carrot worked, according to a 2007 update:

Before the ICMJE policy, ClinicalTrials.gov, the largest trial registry at the time, contained 13 153 trials; this number climbed to 22 714 one month after the policy went into effect (3). In April 2007, the registry contained over 40 000 trials, with more than 200 new trial registrations occurring weekly (Zarin D. Personal communication).

Registration of a trial’s plans – what researchers plan to test, and how – also means there’s a pixel trail if reporters, or any member of the public, wants to see if scientists changed the goalposts to make their results look better, or buried negative results. (Also see Ghost protocols: Scientists propose a way to plug major holes in the medical literature)

Continue reading