Friday, November 14, 2014

Big Pharma Plays Hide-the-Ball With Data

NewsWeek has a Story featured on their front cover about how "Big Pharma Plays Hide-the-Ball With Data"



The story is focused on the general and universal problem of publication bias.

Naturally the problem is also a major issue for psych drug manufacturers.

It is much too long to quote in full but we can feature some highlights here.
On the morning of March 2, 2005, a 14-year-old Japanese girl woke up scared. At first she thought someone was outside the house watching her, but then she decided the stranger must be inside. She wandered restlessly and, despite the cold weather, threw open all the windows. Later, over a meal, she declared, “The salad is poisoned.” Two days later, she said she wanted to kill herself.

This teenager with no history of mental illness was diagnosed with delirium. The night before the hallucinations started, she began taking an anti-influenza drug called Tamiflu (generic name: oseltamivir), which governments around the world have spent billions stockpiling for the next major flu outbreak.

But evidence released earlier this year by Cochrane Collaboration, a London-based nonprofit, shows that a significant amount of negative data from the drug’s clinical trials were hidden from the public. The Food and Drug Administration (FDA) knew about it, but the medical community did not; the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture. When results from those unpublished trials finally did emerge, they cast doubt over whether Tamiflu is as effective as the manufacturer says.



Knowing about negative results is not just useful; it is essential to good science. Randomized clinical trials are considered the best way to test a drug: Get two groups of patients with the same problem, give one group an experimental treatment and see if it works better than no treatment. Even better, amass the results of dozens of similar clinical trials, level the differences and draw better conclusions from a larger amount of data. That’s called a systematic review.

Problem is, a systematic review only works if the reviewers have all the information—good, bad and inconclusive.

“In baseball, it is easy to find out just how well Cal Ripken has hit against various pitchers in the past, at home or away games, in recent weeks or during his career,” Dickersin and Rennie wrote. “Yet in medicine, there is no comprehensive source for finding out similar, accurate statistics for medical interventions. How can baseball be better organized and keep better records than medical science?”

One reason is that drug companies have so much to lose. “The potential economic implications of publishing an unfavorable study are really significant for pharmaceutical companies,” says Christopher W. Jones, who studies publication bias at Cooper Medical School of Rowan University. “And clearly those incentives have an effect on the way they choose to present their data to the public.”



Publication bias in clinical trials was, for a long time, something only scientists cared about. But lately the issue has raised a crop of lobbyists and gone mainstream. In 2005, John P.A. Ioannidis, a researcher at the Stanford School of Medicine, published a scientific paper under the provocative heading “Why Most Published Research Findings Are False” and mentioned publication bias. And British doctor Ben Goldacre leads a movement called AllTrials. His TED talk on publication bias has been seen 1.8 million times.

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