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Linking you into the Avandia story…

The diabetes drug Avandia is hitting the headlines internationally. This New York Times report gives a blow by blow account of the Food and Drug Administration’s panel hearing:

“A majority of the advisory panel of the Food and Drug Administration voted today to restrict the sales of Avandia, a controversial diabetes drug, because of its potential risk for causing heart attacks. The 33-member advisory committee was deeply divided. Twelve voted to remove Avandia from the market altogether; 10 for continued sale but with new label revisions and possible restrictions; 7 to add more warnings and 3 for no change at all. But the votes can also be viewed as a decision by a majority, 21, to continue allowing sales of Avandia, with more restrictions. A final decision will be made by the F.D.A. at a later date.”

More here from consumer rights campaigner Sidney Wolfe’s group.

This Wall Street Journal health blog also links to a Glaxo statement.

Meanwhile, a little bit of history. In 2007 the Union of Concerned Scientists urged that scientists with ties to the manufacturer be excluded from FDA decisions.

This link shows some of the history on the Therapeutic Goods Administration website, but there’s nothing there – yet – yet about the latest news.

***

Update: Thanks to Agnes Vitry at the University of South Australia for the pointer to this recent editorial in the Journal of the American Medical Association, which gives a useful overview of the Avandia history, and argues that the safety risks aren’t justified, given the lack of evidence of therapeutic benefit and the availability of a safer alternative. “Rosiglitazone and the Case for Safety Over Certainty” by Dr David Juurlink, from the Sunnybrook Health Sciences Centre in Toronto.

***

Update: So what do Australian experts think about Avandia and the latest news?

Dr Agnes Vitry, a Senior Research Fellow at the Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, says: “Personally, I don’t understand why such a drug is left on the market. The whole point of controlling blood sugar in people with diabetes is to prevent macrovacular and microvascular adverse events. With no evidence for this benefit with Avandia but having strong concerns about the opposite (increased risk of cardiovascular morbidity and mortality), why would you bother keeping such a medicine on the market? With PBS data showing there have been 69,932 prescriptions this year so far, although the use of this drug is decreasing in Australia, there is still too much used!”

***

Dr Peter Mansfield, a GP and the Director of Healthy Skepticism, says:

“The FDA committee’s failure to put safety first in the case of Avandia illustrates two key issues: misplacement of the onus of proof and the use of surrogate measures rather than important measures.

Before a drug is approved the onus of proof is on the manufacturer. However all the manufacture is required to do is show that their drug is better than placebo for a surrogate measure.  For example Avandia was approved because it reduces blood sugar levels. There was no good evidence available when Avandia was approved regarding what really matters:  If  diabetics take Avandia do they live longer before having major complications of diabetes such as heart failure and death?

After a drug is approved, the current system incorrectly puts the onus of proof is on anyone who thinks a drug should be banned. To the extent that a company controls the evidence they can keep a bad drug on the market by ensuring it is not studied well enough to prove that it is harmful.

Because drug manufacturers bias, be it intended or unintended, poisons research, pharmaceutical manufacturers should not be allowed to fund research.

Instead, research should be funded by competitive grants from agencies such as the Australian NHMRC  and the American NIH. These agencies are not perfect but they are much less biased and much more amenable to improvement.

More than enough money can be found for research from the huge economic benefits that can be gained by abolishing patent monopoly protection.”

3447461416_05b1850c29_b

This photograph has been provided by Liu, Wei-liang, a pharmacist in Taiwan, via Flickr. Thank you!

Comments 5

  1. ron batagol says:

    As is often the case when the balance between risk and benefit of using a particular drug is carefully considered, it takes a lot of well-targeted research resources before we can(maybe?) definitively identify a specific adverse effect beyond the “probability”, with or without plausible explanation, phase. If, as in this case, an alternative drug is available which serves the same therapeutic purpose for which there seems to be less of a risk of such an adverse outcome, it is hard to justify continuing to use the drug under “suspicion”

  2. VicCherikoff says:

    This is a farce. Maintaining a healthy blood glucose response is simple without drugs. We have dozens of people, many Type 2 diabetics recognizing that one particular superfood formulation is beneficial to smoothing out the bumps in blood glucose after a meal.

    High antioxidant intake helps reduce cellular insulin resistance making cells more efficient at absorbing glucose from the blood. A low pH drink prior to eating also has a more physical effect of lowering the glycemic index of the ensuing meal.

    The fact that Australian Aborigines also never suffered from diabetes in traditional times and the absence of the plethora of other diseases of nutrition added to recent research demonstrating the extremely high quality of their wild foods, all add value to Kakadu Juice as a means to top up one’s nutrition on a daily basis.

    Watch the video at http://www.kakadujuice.com/superfoods and discover how wild foods still have a significant role to play in our food choices. Add to this the fact that their harvest, management and development provide opportunities for remote region Aboriginal communities and a culturally appropriate income source as well and the industry can be appreciated as a beneficial force for black and white Australians.

  3. William says:

    @VicCherikoff…and while we are on the subject of evidence, do you have the slightest scrap that any of this reduces cardiovascular events in people with diabetes…because there’s plenty of evidence that it doesn’t…

    Mind you, any evidence that your post isn’t just blatant advertising…

    Or perhaps, you’d like to declare if you have any commercial interest in kakadujuice.com

    Hey Melissa, what happened to transparency?

  4. VicCherikoff says:

    Hi William,

    Yes, we have lots of evidence that blood glucose response is normalized after regular intake of the kinds of foods with which we evolved and that are a feature of Kakadu Juice. Additionally, the benefits of antioxidants and high organic acid intake prior to a meal have been well researched and this work continues with the involvement of Professor Jennie Brand Miller and others at various Universities and other research institutions.

    My interest is to deliver a product of high value not just to those embracing the health benefits but also to the Aboriginal communities who supply some of the ingredients in Kakadu Juice. I do have an interest in the product. I co-formulated it and I take it every day and nutritional research into wild foods has been my life for 30 years. What have you contributed Bill?

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The Croakey Archives
#cripcroakey
#HealthEquity16
#HealthMatters
#IHMayDay (all years)
#IHMayDay 2014
#IHMayDay15
#IHMayday16
#IHMayDay17
#IHMayDay18
#LoveRural 2014
Croakey Conference News Service 2013 – 2019
2013 conferences
Australian Centre for Health Services Innovation Forum 2013
Australian Health Promotion Association Conference 2013
Closing the Credibility Gap 2013
CRANAplus Conference 2013
FASD Conference 2013
Health Workforce Australia 2013
International Health Literacy Network Conference 2013
NACCHO Summit 2013
National Rural Health Conference 2013
Oceania EcoHealth Symposium 2013
PHAA conference 2013
2014 conferences
#IPCHIV14
AIDA Conference 2014
Congress Lowitja 2014
CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014
Racism and children/youth health symposium 2014
Rural & Remote Health Scientific Symposium 2014
2015 conferences
#CPHCEforum
#CRANAplus15
#HSR15
#NRHC15
#OTCC15
Population Health Congress 2015
2016 conferences
#AHHAsim16
#AHMRC16
#ANROWS2016
#ATSISPEP
#AusCanIndigenousWellness
#cphce2016
#CPHCEforum16
#CRANAplus2016
#IAMRA2016
#LowitjaConf2016
#PreventObesity16
#TowardsRecovery
#VMIAC16
#WearablesCEH
#WICC2016
2017 conferences
#17APCC
#ACEM17
#AIDAconf2017
#BTH20
#CATSINaM17
#ClimateHealthStrategy
#IAHAConf17
#IDS17
#LBQWHC17
#LivingOurWay
#OKtoAskAu
#OTCC2017