The Truth Of The Avandia Scare…

May 31, 2007

imagestel.jpgMy phone never stopped ringing …literally!  Apparently the NEJM publication caught the media in a frenzy mood!  The headline noting the increased risk of heart attack with the use of Avandia brought about the public scare and the panic.   This is one case to point where everything written in a well respected journal should be studied, scrutinized and reviewed before offering to the media to be sensationalized!

The real inside story however was never told as to why there was a need to rush the publication coupled with a sensationalized editorial.  Below is The  Wall Street Journal Commentary which I want to share with the readers and my patients as well…. 

As medical information is exploding and becoming more accessible, all of us, particularly physicians, need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas.

Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions.  The behavior of the New England Journal of Medicine (NEJM) is a case in   point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration’s more careful evaluation of the same issues. The journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal’s motives were made bare by its own editorial on the matter.    

While there are “questions” whether Avandia is associated with certain heart risks — so far unsupported by more rigorous, randomized studies   and  extensive review by the FDA and other authorities around the world — the NEJM study doesn’t add much new insight into those issues because of its own limitations.   But you wouldn’t know that from the way the Journal hyped its analysis to the media or opined about the study’s significance. These facts weren’t lost on clinicians and even NEJMs competitors. The Lancet,  NEJM’s British sister-publication, said of the study, “Alarmist headlines and confident declarations help nobody.” A top American medical researcher  told WebMD, “I can’t help but wonder if the NEJM is functioning more like the mainstream press than a scientific journal at this point.”
      
 The paper which re-analyzed the results of 42 earlier studies of the drug found on the Internet, revealed that Avandia might cause a small increase in the absolute risk of a heart attack. But the study that the authors did, called a”meta-analysis” because it aggregates results from lots of studies to generate a larger sample, contained a number of serious limitations.
 

Among other things, the authors of the NEJM study based their conclusions that Avandia caused a higher heart risk on just a handful of cardiac events, none of which they could go back and verify, because, unlike the  FDA, the authors didn’t have access to confidential patient records

Dr Goetlleib who wrote the commentary further noted that….Absent was any discussion by NEJM of the drug’s benefits, or advice  from  diabetes experts on how doctors should counsel their patients based on the  information.

So Better Be informed Before We Judge!

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3 Responses to “The Truth Of The Avandia Scare…”

  1. Doc Gerry Says:

    A friend of mine sent me this email form the online publication of Lancet: the counterpart journal of NEJM in Europe.

    Here’s the latest from the Lancet: You can access it thru this address: http://multimedia.thelancet.com/pdf/rosiglitazone_response.pdf
    Key data points include:

    The recent meta-analysis published in New England Journal of Medicine, which has been widely cited in media reports, inexplicably omitted the total percentage number of events. The actual number of heart attacks represents a very low frequency of events (0.6% of the more than 26,000 patients studied) and the difference in rates of heart attacks between Avandia and controls is less than 0.1%

    Further analyses from ADOPT and DREAM – two long-term prospective clinical trials – show that the incidence of ischaemic cardiovascular events with Avandia is comparable to the two gold standard medicines (metformin or a sulphonylurea) used to treat type 2 diabetes (ADOPT) or to placebo (DREAM).

    Findings from a soon-to-be-published, real-world study of more than 30,000 diabetes patients in a managed care database in the USA show the incidence of hospitalisations for heart attack, and/or for a surgery known as revascularisation for patients on Avandia is the same as for other diabetes treatments. These data are available on line on the clinical trials register.

    The independent safety monitoring board for the RECORD trial – a large, long-term clinical trial, which has been designed to look at cardiovascular outcomes in patients with type 2 diabetes – reviewed an interim analysis of cardiovascular endpoints in all study participants, and determined that the study should be allowed to continue.

    To summarise, data from long-term, large-scale, prospective clinical trials show that the overall ischaemic cardiovascular safety profile, including cardiovascular death, among patients treated with Avandia is comparable to patients treated with two other widely used diabetes medicines.

  2. MM Says:

    Dr — thank you for keeping patients informed. BTW, I looove the other posts here! Very helpful!!! Health is wealth 😉


  3. […] The Truth About The Avandia Scare […]


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