A know-nothing from The New York Times believes that the pharmaceutical industry is intentionally hiding data from clinical trials. ACSH s Dr. Josh Bloom and The Manhattan Institute s Dr. Paul Howard disagree. They don t buy claims that the pharmaceutical industry is burying data that would expose its products as expensive frauds.
Writing in Medical Progress Today Spotlight, they rebut a recent op-ed by Ben Goldacre:
Current trial registration protocols aren't perfect, and Goldacre is right that there's a bias among academic journals to publish positive data from successful clinical trials. But so what? Good news (rare in the drug development world) attracts much more scientific attention than failure (which is the norm). This is human nature, not a conspiracy.
The reality is that most drug candidates fail, at enormous cost. U.S. pharma companies spend close to $60 billion annually on drug development but launch only about 30 or so new medicines (and that's in a very good year).
And if that wasn't daunting enough, eight out of ten successful new medicines won't even generate enough income to make a profit, let alone cover the cost of all the failures. This is hardly the picture of an industry pawning expensive or dangerous placebos off on gullible regulators and doctors.
Goldacre also conveniently ignores that all clinical trials data, good or bad, are disclosed to regulators - the U.S. Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA) in Europe. Regulators carefully review these data (often hundreds of thousands of pages) and then decide whether the risks of a drug outweigh its benefits - a difficult, expensive, and judgment-laden process that contributes enormously to the cost and time required to bring new medicines to patients.