It seems almost trivial that it comes down to something quite that simple, but that is the bottom line. A case that illustrates the point are the two articles by Robert Gibbons et al that were published in the Archives of General Psychiatry earlier this year. The articles concluded that the antidepressants were safe and effective for use in adolescents by reanalyzing the data from four previous trials of Prozac. As Dr. Gibbons put it in a
Medscape article:
"We were interested initially in looking into the efficacy of antidepressants, so we approached Eli Lilly to see if they would part with all of their longitudinal data from their randomized, placebo-controlled trials, and remarkably, they said ‘yes,’ " said Dr. Gibbons. "We said that we were going to analyze all the data and write a paper and were not even going to show it to them, and they said ‘fine’."
I went on for months about these article because his papers had no data, only a terse description of his analytics that were hard to follow and impossible to reproduce, and his conclusions that were counter to any other meta-analysis done on these same studies. The problem? None of the rest of us have the data. Lilly gave it to him, but neither Lilly nor he made it available to the rest of us. The Archives of Psychiatry did not allow a number of us to have objecting letters published in a way that would flag the articles in PubMed. So no data and no recourse for an article that makes a conclusion that should be thoroughly reanalyzed because of the gravity of the claims.
Likewise, the raw data for GSK’s Paxil Study 329 has been held private while the Internet filled up with refutations of the article’s conclusions and innumerable court cases have been settled based on damages from this fallacious, ghost-written article. The data was recently published on the GSK web-site [11 years later] and the mis-analysis was easily detected by a rusty boring old man. Had the data been accessible from the start, they would never have published the article with it’s erroneous conclusions.
Last week, five damages suits were settled by Janssen related to off-label promotion and unacknowledged adverse effects that would’ve been readily apparent had the raw data been available long ago. In the raft of Janssen suits now working their way through the courts, all of the problems would’ve been easily detected had the data been published early on.
“I don’t mind if you’re my doctor and you’ve given talks for industry. My concern is not that you’ve been paid by industry, but that you’ve been fooled by industry. The key conflict is whether people are hiding data from you.”
The obvious retort to this call for data transparency is, "How do you expect us to make a profit on these drugs that we’ve worked so hard on if anyone can reanalyze our data and find all of the problems?" The answer is simple, we don’t. We don’t expect you to make a profit on drugs with hidden problems. You shouldn’t either. Problems don’t mean we won’t use the drugs. We’ll just use them a lot less, sure enough, but we’ll be using them a lot more safely and a lot smarter.
But when a questioner, claiming himself “speechless” in the face of Healy’s arguments, asked whether he should just stop prescribing antidepressants, Healy said no. Healy prescribes them himself, but believes that the role of the doctor is to manage risks, not view drugs as harmless. “Medical treatment is poison, and the art of medicine is trying to find the right dose,” he said.
and the right patient…
I wonder how the psychiatrists in the audience interpreted “the right dose”?
They must have felt reassured they were doing fine. I believe Dr. Healy misspoke with that response.