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Posts tagged with "Clinical Trials"

  • Clinical Trials

    This Had Better Be Good

    I wrote a brief wrap-up on the FDA’s concerns about the new Bristol-Meyers Squibb / Merck diabetes drug Pargluva (muraglitazar). It’s officially “approvable”, but the FDA wants more cardiovascular safety data before it can be sold. But just this morning the JAMA web site has rushed out an article from a team at the Cleveland… Read More
  • "Me Too" Drugs

    By a Nose in a Head to Head

    One of the other incorrect lessons that people might take away from the press accounts of the antipsychotic trial is that drug companies have been comparing their medications to placebo too often. And why would you do that unless you were scared that you wouldn’t be better than the competition? What’s with these people, anyway?… Read More
  • "Me Too" Drugs

    No Clear Winners

    You’ve probably seen the headlines about the recent NIH-sponsored “CATIE” study comparing five anti-psychotic medications. The result, which is what made the whole thing newsworthy to the popular press, was that it was hard to distinguish among them, with the oldest generic working as well as (or better than) the newer drugs. But… Read More
  • Clinical Trials

    Muraglitazar’s Turn

    There’s a lot of metabolic disease news this week from the FDA. We’ll get to the inhaled insulin decision next week, but I thought I’d try to catch the next one before it happens. On Friday they’re reviewing the first PPAR alpha-gamma ligand to make it to the regulatory approval stage, Bristol-Meyers Squibb’s unmelodio… Read More
  • "Me Too" Drugs

    Gritting Our Teeth

    I’ll tell you a company that’s been watching what’s happened to Merck and thinking hard about it: Sanofi. Well, OK, everyone in the industry has been looking at Merck’s situation and shuddering, but I suspect the people at Sanofi(-Aventis) are especially jumpy. Why? Rimonabant. Rimonabant, which will come to the market next… Read More
  • Cardiovascular Disease

    Where’s the Combo?

    Gruntdoc wonders about why a particular combination therapy isn’t available yet. Skin infections with methacillin-resistant staphylococcus aureus (MRSA), which I hope I never come any closer to experiencing, are treated with one of several antibiotic combinations, but they’re all administered as separate drugs. The answer is what you mi… Read More
  • Cancer

    Still Not All That Easy

    Speaking of cancer trials, I mentioned the other day how they tend to be smaller than those for many other diseases. But that doesn’t mean that they’re always easy to run, as a search for “clinical trial design oncology” will show. Note the number of people offering to help you out, via seminars, consulting visits… Read More
  • Academia (vs. Industry)

    The NIH in the Clinic

    OK, I couldn’t resist. Let me reiterate that I completely admire the NIH’s commitment to basic research; it’s one of the real drivers of science in this country. But they’re not a huge factor in clinical trials. Academia does more basic research than pharma; pharma does more clinical work than academia. Here are some statist… Read More
  • Academia (vs. Industry)

    One More On Basic Research and the Clinic

    OK, one more on this topic before moving on to other things for a while. The Bedside Matters medblog has a better roundup of the reactions to my post than I could have done myself. And “Encephalon” there also has one of the longer replies I’ve seen to my initial post, worth reading in full. Read More
  • Academia (vs. Industry)

    How It Really Works

    So is this the attitude we’re up against? Here’s a thread on Slashdot on the clinical trial disclosure issue – titled, I note in light of yesterday’s post, “Medical Journals Fight Burying of Inconvenient Research”. My favorite verb again! The comments range from the insightful to the insipid (for another good rea… Read More