Nate Silver is all the rage, but when Dean Baker tweeted “Excellent
I had to read it. To me the hero of the article is a meta analyst who used data collected by others to discover that Avandia causes increased risk of heart attacks. Meta analysis, and the name is Nissen.
To see whether his suspicions were warranted, [Steven E.] Nissen, with colleague Kathy Wolski, set out to assemble the data from every trial of Avandia that they could find. The more data they had, the more likely they could accurately gauge the risks. The drugmaker refused Nissen’s requests for data, but because of litigation brought by Eliot Spitzer, then New York’s attorney general, the company had been forced to make some of it public. In all, he discovered the summaries of 42 trials — 35 of them unpublished. Most of them had been sponsored by Glaxo.
After analysis, the results were stark: Avandia raised the risks of heart attack by 43 percent and of death from heart problems by 64 percent.
Nissen and Wolski submitted their findings to NEJM on May 2, 2007.
Normally, an article takes several months to get published, but Drazen put it on a fast track, publishing it on the NEJM Web site 19 days later, on May 21.
It is also true that the reporter did a very thorough job on an important but complicated topic and that Journal editors are trying to deal with the problem (and not just by getting a manuscript out in 19 days see below) and Eliot Spitzer is a hero in spite of trouble keeping his pants on.
I read about the problem of pharmaceutical company money distorting science in an article written by two editors of the New England Journal of Medicing the already retired Arnold Relman and the then editor in chief Marcia Angell. Angel is still actively warning of the danger and is quoted in the article.
Importantly the value of meta analysis is recognized and regulators and journal editors have made sure it is possible (and I learn are going further)
Medical journals have also acted in concert. In 2004, [NEJM Editor in Chief Jeffrey M. Drazen and editors at other journals made it much harder for companies to hide unflattering experiments, requiring drugmakers to register a summary description of their trials in a public database.
“The drug companies went nuts about requiring registration,” Drazen said. “They said, ‘That’s secret information.’ We said, ‘That’s bull—-.’
I like Drazen’s prose style too. The point of this post was going to be that the Clinical Trials Register makes meta analysis possible and that data nerds should get on it. Only reading the article did I learn that Nissen and Wolski were way ahead of me (I also recall an excellent meta analysis of anti depressant trials using data from the registry which I read in the NEJM — this is one of my actual fields of actual research).
Now I learn that even more data will be made available
In the wake of controversies arising around Vioxx, Avandia and Celebrex, many in the medical world have sought ways to ensure that drug research is free of commercial bias.
One of the leading proposals would be to compel drug companies to release all of the data from trials of drugs that are on the market.
Over the summer, the European Medicines Agency — the continent’s counterpart to the FDA — said it will move toward requiring the release of all such data. Glaxo, too, has said it is preparing for such a release, though other companies have yet to follow suit.
Data freeks take note.