Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Why rosiglitazone would not have been approved today

Larry Husten, PhD
Meds
March 7, 2010
Share
Tweet
Share

Avandia continues to dominate cardiovascular-related news this week. Recently, the AHA and the ACC issued a highly detailed, thoughtful, though perhaps slightly over-diplomatic science advisory on TZDs and CV risk. Taking a completely opposite tack, GSK, in no mood to take prisoners, and apparently about to nominate itself for a Nobel Prize, issued a 30 page White Paper in response to the Senate report published on Saturday.

At the core of the AHA/ACC advisory is a detailed analysis of all the available rosiglitazone data. I’m not aware of a more detailed or objective analysis. After a careful review of the data the authors conclude that “an association between rosiglitazone and IHD outcomes has not yet been firmly established,” but goes on to admit that “sufficient evidence has emerged to raise concerns about a potential adverse effect.” The authors, including first author and chair, Sanjay Kaul, appear to endorse the FDA and European Medicines Agency decisions in 2007 to allow rosiglitazone to remain on market, though with additional warnings. But it’s hardly a strong endorsement. Not surprisingly, they write that “given this clinical equipoise, we call on academic researchers, industry, and government agencies to collaborate on definitive randomized trials to answer these important clinical questions.”

By contrast, the GSK White Paper makes no efforts whatsoever to be balanced. The document seeks to discredit the Senate report, but GSK harms its own case by refusing to consider that there might be any ambiguity in the issue, or to admit that the company might, at any time, have acted in some way that was inappropriate. Is there anyone out there who is impressed, for instance, by “the extensive measures GSK undertook to study Avandia prior to marketing approval”? The one thing that just about everyone except GSK now seems to agree upon is that the cardiovascular safety of the drug was not adequately studied prior to approval.

Similarly, the company’s claims that it has been “proactive in investigating safety data” is just plain laughable, unless of course attempts to intimidate one’s opponents are considered “proactive.” Finally, the document goes to great lengths to discredit the famous Nissen meta-analysis (and many of these points have some validity, as the AHA/ACC advisory makes clear) but fails to address the multiple reports that the company’s own scientists turned up similar results.

GSK doesn’t do itself any favors with its strategy of massive retaliation, but GSK’s opponents aren’t necessarily helping their case with their extreme tactics either. A recent New York Times’ story about Steve Nissen’s secret recording of a meeting with GSK executives is a case in point. As pointed out by Paul Raeburn, the veteran journalist who covers medical reporting for the Knight Science Journalism Tracker blog, the story turns out to be much ado about very little. The only thing “secret” in the recording of the meeting was the recording itself. There was no actual new information contained in the recording or in the Times article. Though it had at first appeared to be an important story, Raeburn concludes: “maybe not such an important story after all. Sometimes a poorly organized story is a reflection of reporting that doesn’t have much to tell.”

One final thought: it’s clear that by 2010 standards rosiglitazone never would have been approved. The question then is, what to do about a drug like rosiglitazone that has already been approved? What type of danger signal (or lack of efficacy, as in the ezetimibe case) would be needed to warrant removing the drug from the market? I don’t think there’s been an explicit discussion of this issue. Once again, as happened in the debate over ARBITER 6, an important major public health issue has taken center stage and there is a paucity of good data.

That’s the real tragedy here.

Larry Husten is a writer and editor of CardioBrief.org.

Submit a guest post and be heard.

Prev

Using CT scans to diagnose chest pain in the ER

March 6, 2010 Kevin 1
…
Next

Health blog posts of the week, February 28-March 1, 2010

March 7, 2010 Kevin 0
…

Tagged as: Diabetes, Medications

Post navigation

< Previous Post
Using CT scans to diagnose chest pain in the ER
Next Post >
Health blog posts of the week, February 28-March 1, 2010

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

More by Larry Husten, PhD

  • a desk with keyboard and ipad with the kevinmd logo

    The worst abuse of an embargo this medical journalist has ever seen

    Larry Husten, PhD
  • a desk with keyboard and ipad with the kevinmd logo

    The official response to Mark Midei is not satisfactory

    Larry Husten, PhD
  • a desk with keyboard and ipad with the kevinmd logo

    How academic physicians are being used as live bait for journalists

    Larry Husten, PhD

More in Meds

  • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

    Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO
  • A world without antidepressants: What could possibly go wrong?

    Tomi Mitchell, MD
  • The truth about GLP-1 medications for weight loss: What every patient should know

    Nisha Kuruvadi, DO
  • The hidden bias in how we treat chronic pain

    Richard A. Lawhern, PhD
  • Biologics are not small molecules: the case for pre-allergy testing in an era of immune-based therapies

    Robert Trent
  • The anesthesia spectrum: Guiding patients through comfort options in oral surgery

    Dexter Mattox, MD, DMD
  • Most Popular

  • Past Week

    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • Addressing the physician shortage: How AI can help, not replace

      Amelia Mercado | Tech
    • Why medical students are trading empathy for publications

      Vijay Rajput, MD | Education
    • Physician patriots: the forgotten founders who lit the torch of liberty

      Muhamad Aly Rifai, MD | Physician
    • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

      Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO | Meds
    • How collaboration across medical disciplines and patient advocacy cured a rare disease [PODCAST]

      The Podcast by KevinMD | Podcast
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • How dismantling DEI endangers the future of medical care

      Shashank Madhu and Christian Tallo | Education
    • How scales of justice saved a doctor-patient relationship

      Neil Baum, MD | Physician
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Recent Posts

    • How collaboration across medical disciplines and patient advocacy cured a rare disease [PODCAST]

      The Podcast by KevinMD | Podcast
    • 5 cancer myths that could delay your diagnosis or treatment

      Joseph Alvarnas, MD | Conditions
    • When bleeding disorders meet IVF: Navigating von Willebrand disease in fertility treatment

      Oluyemisi Famuyiwa, MD | Conditions
    • The hidden cost of becoming a doctor: a South Asian perspective

      Momeina Aslam | Education
    • Physician patriots: the forgotten founders who lit the torch of liberty

      Muhamad Aly Rifai, MD | Physician
    • The child within: a grown woman’s quiet grief

      Dr. Damane Zehra | Physician

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 1 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • Addressing the physician shortage: How AI can help, not replace

      Amelia Mercado | Tech
    • Why medical students are trading empathy for publications

      Vijay Rajput, MD | Education
    • Physician patriots: the forgotten founders who lit the torch of liberty

      Muhamad Aly Rifai, MD | Physician
    • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

      Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO | Meds
    • How collaboration across medical disciplines and patient advocacy cured a rare disease [PODCAST]

      The Podcast by KevinMD | Podcast
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • How dismantling DEI endangers the future of medical care

      Shashank Madhu and Christian Tallo | Education
    • How scales of justice saved a doctor-patient relationship

      Neil Baum, MD | Physician
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Recent Posts

    • How collaboration across medical disciplines and patient advocacy cured a rare disease [PODCAST]

      The Podcast by KevinMD | Podcast
    • 5 cancer myths that could delay your diagnosis or treatment

      Joseph Alvarnas, MD | Conditions
    • When bleeding disorders meet IVF: Navigating von Willebrand disease in fertility treatment

      Oluyemisi Famuyiwa, MD | Conditions
    • The hidden cost of becoming a doctor: a South Asian perspective

      Momeina Aslam | Education
    • Physician patriots: the forgotten founders who lit the torch of liberty

      Muhamad Aly Rifai, MD | Physician
    • The child within: a grown woman’s quiet grief

      Dr. Damane Zehra | Physician

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Why rosiglitazone would not have been approved today
1 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...