Healthy Skepticism Library item: 18411

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Rich
Avandia Fallout: What you should know as a marketer
World of DTC Marketing 2010 July 12
http://web.archive.org/web/20110219222431/http://worldofdtcmarketing.com/avandia-fallout-what-you-should-know-as-a-marketer/business-of-the-drug-industry/

Full text:

So “is the entire system corrupt?” The answer to that of course is NO, but with oil flowing in the gulf, with billions and dollars spent on corporate bailouts and unemployment still over 9% more and more consumers are becoming distrustful of marketing and big business, especially pharma.

There has been much written over the last couple of days about Avandia and what GSK did or didn’t know. It doesn’t really matter if the FDA takes Avandia off the market or leaves it on the market because in this writers opinion the damage is too severe for this product to maintain any momentum.

Now for a moment think of this: a patient in a new product diabetes trial dies of a heart attack. He was overweight, had high blood pressure along with diabetes. Is the cause of death the drug or is it the fact that he was overweight and may have had CV disease ? How should the death be reported ? These are not easy questions to answer and thus you have a key issue of how data is recorded and analyzed in clinical trials.

From my standpoint I would believe that people who have Type 2 diabetes and have issues with their blood glucose may have a greater chance of CV disease than someone who does not have Type 2 diabetes. Often people who have Type 2 diabetes have the health condition because they are overweight and eat the wrong foods. So do health care professionals really have the time to analyze the data and become statisticians ?

The perception, right now, is that GSK did not report all the data when they submitted Avandia for approval. The most pointed attack on Record comes from a review by Thomas A. Marciniak, a medical team leader in the FDA division that handles heart and kidney drugs. He goes back over the patient records, and finds additional heart attacks he says should have been counted – all of them in patients who received Avandia.

Marciniak writes that the study was “inadequately designed and conducted to provide any reassurance” on Avandia’s safety. Moreover, he finds an alternative way of looking at the data, by stopping the trial when fewer patients had dropped out of the study, that also makes the result look worse. He argues that there is a heart attack risk.

So the key question is: Was the study inadequately designed and was the data an accurate review of Avandia’s safety ? If it was, the issue is then “was this on purpose ?”

Marketing Implications

So what are the implications for marketers ?

The media has picked up on the Avandia story but so far it is not as widely circulated as you would have believed. So far most of the buzz is confined to within the diabetes community.

Eventually someone is going to ask “why didn’t the FDA catch this before ?” and this the issue of safety for other drugs already approved may come into question.
Health care professionals don’t have the time to take a really deep dive into Avandia but I believe that a lot of physicians will move their patients off Avandia to avoid possible “issues” later on.
I do not believe that this will taint the “whole” drug industry as far as providing data to health care professionals but I do believe that some physicians are going to have doubts about clinical results, especially from big pharma. HCP marketers are going to have to work harder now to reassure HCP’s that clinical trial data is relevant. Simply saying “it was done within good guidelines” is not going to cut it anymore.
Consumers/patients who become aware of this issue are going to question even more the FDA process for approving drugs and may want reassurances that drugs are safe and effective. For example. Pfizer goes out of their way to talk about all the clinical trials for Lipitor and safety. However this may not be enough because they may be seen as untrustworthy.
If the entire system is corrupt than “Houston we have a major problem”. As for Avandia, the damage is done and GSK probably should have voluntary removed the product from the market “to re-review all the data as we believe patient safety is first, not sales”. However GSK’s image during this episode has been one of denial and cloak & dagger. Too bad because what they did, or didn’t do, clouds the whole industry.