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Posts tagged with "Clinical Trials"

  • "Me Too" Drugs

    Me Too, Part Two

    As came up in the comments to the previous post, there’s not as much price competition inside a given drug category as you’d think. That’s not because we’re Evil Price Gougers, at least not necessarily. As I was pointed out yesterday, “me-too” type drugs aren’t as equivalent as some people think. The main r… Read More
  • "Me Too" Drugs

    Clinical Trials And What to Do With Them

    Allow me to get a little defensive. If I understand some of the critics of my industry, we spend most of our time making “me-too” ripoff drugs rather than doing something that provides any clinical benefit to patients. And, if I have this right, here’s how we determine efficacy: we run clinical studies until we… Read More
  • Clinical Trials

    Fast, Cheap, and Sometimes Even Good

    The New York Times has a good article this week on a trend in clinical trials that’s been developing for several years – small intensive trials in humans, run before giving the go-ahead for the real thing. It makes a lot of sense, but only when you can use it to ask (and answer) the… Read More
  • Clinical Trials

    Primum Non Nocere, Eh?

    The placebo effect is a real problem in some clinical trials. It varies, but in things like antidepressants it’s a major factor (while with, say, pancreatic cancer it doesn’t change the results too much.) In a given sample of depressed patients, there are a fair number of people (20 or thirty percent) who will respond… Read More
  • Clinical Trials

    The Journals Fight Back

    So it turns out that the major medical journals have their own plan for bringing on a clinical trial database: they’re going to require companies to register trials before they’ll allow publication of their results. I was taken aback at not having heard anything about this idea, until I saw that no one else in… Read More
  • Clinical Trials

    Your One-Stop Clinical Data Superstore?

    There have been plans, over the years, for some sort of data repository for clinical trials. Nothing’s ever worked out. The only place that all of this is collected is at the FDA, and they only have the ones that companies have submitted because they were requesting a new approval or a new indication. If… Read More
  • Clinical Trials

    Cue the Music

    New York Attorney General Eliot Spitzer has found what must look like another target-rich environment: the pharmaceutical industry. As many readers will have seen, he’s initiated a lawsuit against GlaxoSmithKline for their handling of clinical trial data for the antidepressant Paxil (paroxetine). As far as anyone can tell, this suit is the fi… Read More
  • Business and Markets

    Pravachol vs. Lipitor Update

    In my March 11 piece below, I mentioned the possibility of Pravachol competing on price with Lipitor. But over at Forbes, Matthew Herper has pointed out that it’s currently more expensive. What BMS is going to do with this drug, I can’t imagine. There’s also a good story in the Newark Star-Ledger about the whole… Read More
  • Business and Markets

    Ignorance Was Bliss

    Just a brief note today about the “PROVE-IT” study that Bristol-Meyers Squibb ran and has now reported on. This was their big shot at Pfizer’s Lipitor, their chance to show that their own statin, Pravachor, was just as good or better. The study was big, it was long, and man, was it expensive. It’s just… Read More
  • Clinical Trials

    More From the Me-Too Front

    Some interesting mail has come in after last week’s post on comparative clinical trials. Reader C.B. that I spoke about here some time ago, but should have raised again: “It seems to me that something else is being left out: not all patients respond the same way to any particular drug. . . Suppose that… Read More
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