Most Avandia Supporters Have Ties To Glaxo
11 CommentsBy Ed Silverman // March 19th, 2010 // 7:05 am
And so the debate over untoward conflicts of interest rages on. The latest installment is brought to you by BMJ, which has published a paper by a team of Mayo Clinic Researchers, who found most scientists who published articles supporting GlaxoSmithKline’s Avandia diabetes pill after it was linked to a risk of heart attacks in 2007 had financial ties to the drugmaker.
Of 202 articles reviewed, 108 - or 53 percent - had a conflict of interest statement, and 90 authors, or 45 percent, had financial conflicts of interest. Authors with a favorable view of the risk of heart attack were more likely to have financial conflicts of interest with makers of antihyperglycaemic drugs, in general, and with drugmakers who sell Avandia and similar pills - Eli Lilly and Takeda - than authors who had an unfavorable view, according to the BMJ paper.
Of the 90 studies with conflicts of interest, 69 - or 77 percent - had a statement disclosing the conflict of interest in the article itself. The other 21 studies with conflicts, or 23 percent, did not disclose relationships, which were discovered through searching other publications by the same author or the Internet. Three, or 14 percent, of these 21 studies published a statement declaring no conflicts, the BMJ authors wrote. And only 6 percent of those with positive opinions about Avandia didn’t receive industry funding or fees.
Disclosure rates for conflicts were “unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the Avandia controversy and their conflicts with drugmakers,” the authors write.
“Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of (Avandia) in patients with diabetes and conflicts, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.”
“We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fuelling this fire. From our findings, it appears that the answer is yes. We realise that key opinion leaders who report competing financial interests may not necessarily be biased by these financial relationships, but our findings indicate a strong association that users of the scientific literature should recognise,” they conclude.
“Of the 202 publications reviewed by the authors, only 10 were original scientific research,” a Glaxo spokeswoman told Reuters. “Many of the articles reviewed were opinion pieces - editorials, commentaries or letters. It is important to note that the authors’ conclusions do not impugn the validity of the scientific data.”
Photo courtesy of Jerome Kassirer
patrons99
This is even more proof, as if we needed more, that most of the published medical literature over the last 20 years should be piled up and burned. It cannot be trusted. Ditto for CME and medical practice guidelines. This puts both patients and their doctors in a very bad position. There are very few places we can go for information we can trust. COIs with pharma are “fueling this fire”. Our lawmakers need to know that the system is broken. Ghostwritten “research” and both direct and indirect transfers of value from pharma to academic medical centers and KOL’s are, in substantial measure, to blame.
pharmavet
In my opinion, original research (i.e. prospective studies, not meta-analyses, etc.) conducted prior to 2007 and published anytime thereafter would be less subject to bias unless the researchers somehow had a crystal ball and knew that Nissen would publish his meta-analysis showing relationship between Avandia and cardiovascular events in 2007. That is, you can’t bias a research study without know what to bias it towards or against. That’s why bias would be less likely if the prospective study were undertaken pre-Nissen.
johns
total mess as usual.
Laurie
“That’s why bias would be less likely if the prospective study were undertaken pre-Nissen.”
If the goal is financial, then the bias was always towards financial gain….now they’re just getting caught.
GSK is known for being less that forthright in their clinical trials across the board.
pharmavet
Sorry, Laurie. Last time I tried to get a clinical investigator to work for free I was turned down. Would you do your job for no paycheck?
notnissen
But do they ask the other question, are investigators with ties to Takeda more likely to publish negative reports?
Former Pharma Marketing Director
Pharmavet, we need independently sponsored and peer reviewed trials. If the company holds all the data and manipulates it to suit their own marketing agenda, then that is a big problem.
The cases that are being brought up here clearly show that that is what has been happening….
We cannot rely on a for profit business to do the right thing, plain and simple….
The other way around this is to put black box warnings on everything, make full disclaimers and let the patients know that in many cases they are rolling the dice and they are just one crap shot away from a heart attack or (fill in the AE) and do they think the risk is worth the benefit.
By the way, ecellent article in this weeks Time Magazine
” The Twilight of the Elites, why we have entered the post trust era”
pharmavet
FPMD, good article in Time. A bit hyperbolic; if you take it to its logical extreme, then we are headed for anarchy, or at least a revolt of the proletariat against the bourgoise robber barrons. I personally believe that people will always strive to acquire the means to live a better life, socially, economically, etc. I suggest reading Thorstein Veblen’s book, “Theory of the Leisure Class”, which coined the term “conspicuous consumption”. Or, if you prefer someone more modern, try economist Lawrence Kudlow who authored the book “American Abundance: The New Economic and Moral Prosperity”. My favorite quote of his: “The American way of life is non-negotiable”. An optimist for sure.
elmore
It’s been said a million times before but most of this stuff is the work of ghost writers. The authors whose names are on the papers agree to be included so they’ll continue to get income. And the authors who are approached to be included are already known to be “friendly” to the drug and company.
Former Pharma Marketing Director
Pharmavet,
Given all that I have experienced in my professional life and personal life, I still remain optimist. However, the only way we can fix anything is by standing back and objectively thinking about what we are doing. This is not something that we do very well these days. I am appalled at the missed opportunities for real improvements and measured successes in all areas simply because we refuse to critically evaluate the evidence that lands before us.
We have allowed the marketing departments to become too powerful. This is interfering with science and the results are detrimental in many cases.
When we let the scientists do the work they are supposed to do we have much better successes.
Overzealous marketing puts the wrong drug into the wrong patients hands and that is what creates the problems.
No we are not headed for anarchy, and I didn’t get that from the article. Head the warnings, it is time we fixed what is wrong…
It is time to do more than just talking.
worksforpharma
A point was made earlier that clinical investigators do not work for free, and this kind of research is astonishingly expensive. Unless the government stops slashing investment in reseach and finds a few billion dollars to invest in grants, the bulk of the funding is going to come from drug and device companies who are hoping that the research will show their product is superior. And do you know what? Sometimes it IS superior.
I am not convinced that corporate-sponsored research is all completely untrustworthy, which is a strong implication of much of this thread. I will grant that there are cases of abuse, and that casts a pall. However, unless you want to have all studies repeated, you need to do a close analysis of the data and draw your own conclusions. Don’t feel guilty or hoodwinked if once in a while you believe it’s good science.