AvandiaGate: Silencing A Critic
17 CommentsBy Ed Silverman // June 2nd, 2007 // 10:32 am
Did Glaxo try to intimidate John Buse into keeping his mouth shout about his concerns with the diabetes drug? Congressional investigators are examining what they call “very serious†claims that Glaxo “silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia,†according to a letter sent to Glaxo last week from the Senate Finance Committee.
His tale will be told in detail during Congressional hearings on Wednesday. “It was upsetting, but it was not life-altering,†Buse tells The New York Times. “I hold no ill will toward Glaxo or any of its employees.†Buse, a University of North Carolina endocrinologist and upcoming president of the American Diabetes Association, was part of a self-described ‘gang of three’ docs who several years ago complained to Glaxo about Avandia risks and marketing - but no good apparently came of it.
One of them was Anne Peters, a diabetes expert who runs a clinic for Los Angeles County and is affiliated with the Keck School of Medicine at the University of Southern California. About five years ago, she told the Times, she helped change the formulary for Los Angeles County so that patients in her clinic would get prescriptions for Takeda’s Actos rather than Avandia.
“The Avandia people, it was just so surprising, they asked me what I wanted to keep Avandia on the formulary,” she says. So she asked Glaxo to establish a database at the clinic that would track the outcomes of patients on both drugs. The database would have cost several thousand dollars, and a Glaxo rep replied: “That’s all you want? Other doctors ask to go to the Caribbean.â€
You can read the full story here.
Chris
A small point: because a rep said that “other doctors ask to go to the Caribbean” does not mean that was on offer. Unfortunately that type of behavior is not unheard of amongst the more ‘important’ physicians. Of course the industry of old helped to create that situation through some of the excesses we all know of, but physicians are human too: they are not all objective, selfless paragons of virtue - there are many who know and play the system very well indeed.Let’s just remember that when we see hysterical posts that often could do with some balance in their tone.
Ed Silverman
Hi Chris,
No, it doesn’t mean it was an offer. It just says what it says.
But I don’t think this post was hysterical. In fact, this was very straightforward - I highlighted a few of the most interesting graphs, to me, that were in the NYT story; the attribution is there in the post and at the bottom with the link.
And unlike some other posts, I didn’t add my own commentary to this one - I just let the info speak for itself. Again, I highlighted the info I found most interesting - and I zeroed in on what I did because the behavior you describe is/was unfortunate. And its a reminder of ‘the excesses’ that have caused a problem. Perhaps the NYT reporter reacted similarly? After all, that’s where remarks first appeared.
Thanks for writing
ed
Laurie
This may have been considered hysterical, IF this was the first time that GSK was accused of doing this. But it’s the pattern of deception with any of their drugs that ultimately come under fire.
In this case GSK is trying to minimize the “damage” of a risk that they knew full well and have admitted, was there. Begs the question why??
Chris
I think I didn’t make the intended point well at all. The way the article was written (I read the Times too) stated that the rep normally is asked for much more than a database. The implication, to me, was that the woman in question would have got her trip to the beach had she asked for it, and it was that I felt was somewhat misleading. I know from experience that to be true, and as I said, this is largely a consequence of pharma’s past excesses.I know Ed didn’t add comments - didn’t think I suggested as such. My ref to hysterical posts should have said ‘comments’ not ‘posts’ and was not in ref to this one, but to the ones almost always seen in response to any major, minor or perceived wrongdoing by pharma.And again, come only from a minority of highly-opinionated and apparently anti-pharma individuals.
Did GSK do anything different than any other company would have done in the same position? Perhaps not and maybe that’s the point. However, other articles written over the past week do highlight the growing politicization of the NEJM and how Nissen had his study leaked well before publication along with Waxman apparently in the know too. I guess there are two sides to all of this and aggregated coverage of it, like other industry stories, rarely misses the chance to skewer industry.
Insider
Chris,
Dr Peters says of “the Avandia people”:
“they asked me what I wanted to keep Avandia on the formulary”.
That’s pretty “barn door” to me!
Cheers
Jack
Laurie
I have no love lost for pharma, that’s pretty well known. I’m not antidrug, heck I’m a nurse!! But I’m all about full disclosure to a patient and a doc. If a drug has great benefits, but a nasty risk profile…some patients may still choose to take it. But they have the right to have all of that information available to them.
The continued denial by pharma of problem drugs makes the general public skeptical of all drugs. Pharma has created this mistrust. They even continue to fight for market share, when a drug gets an FDA warning, when hidden clinical trials are revealed showing no efficacy. At that point it’s no longer about patient outcome, it’s about profit.
There are good drugs and there are bad drugs. It’s all about pulling the bad drugs, even when they are huge profit makers.
Chris
I am English and come from a race that is overly respectful to the medical profession. (Which is OK as long as it works.) I have worked in the industry for almost 30 years, 18 in the US, and still am amazed how those I know from the US population are so absolutely confident about what they want, need, etc. Based on what? An internet print out? A personal referral from Professor Google? A second opinion from that out of plan Dr WebMD? When I see comments that patients in the US should have information availabel to them I wonder for what purpose. They (we) are not qualified to judge why a drug may be suitable or otherwise based on an e-thimble full of info. There are probably similar examples from other industries but I thinjk my poinbt is clear - leave pharmaceutical, therapeutic, and clinical decisions to the professionals. Let’s hope that they have access to clinical, not political information via peer review journals, and that they retain the healthy scepticism they have always possessed about the info brough to them by drug reps.
Chris
I just learmed that my computer has spell check.
Will try harder in future!
Laurie
Chris,
If a clinical trial is done on a drug and that drug shows no positive effect and shows an increased risk of suicide,violence,aggression etc..AND isn’t approved by the FDA…..would you give it to your child? This is just one example of what we are seeing here in the states. Granted, this is only one group of drugs, but it’s a symptom of a bigger problem. When 5 clinical trials are done on a drug and ONE turns up a slight incidence of efficacy and that ONE trial is put in a medical journal and is presented to the FDA, with no mention of the other trials..that is a problem.
Every drug has side effects. But we’re not talking nausea, rashes, and headaches here. We’re talking kids killing themselves and others.
I have alot of respect for the medical profession. There are alot of excellent doctors out there. But, as with any profession, there are those who are in a field for the wrong reasons.
Full disclosure is critical. People are not stupid. They don’t want to be left in the dark, especially about something they are putting in their own bodies. If a person takes a drug, has no idea of the potential adverse reactions, and HAS an adverse reaction that goes unrecognized as such…who benefits from that? No one.
Doctors are no longer on the pedestal that they were on 50 years ago. And that’s a good thing. Good health is a collaboration between the doctor and the patient. Arrogance and a holier than thou attitude has no place in medicine. Outcomes are always better when the patient and doctor have a working relationship based on trust. I see good ones everyday…sadly I also see the results of bad ones.
Pharma’s backroom antics are being revealed, which is good. Maybe with drastic changes we can get back to restoring faith in the pharmaceutical industry. They are an integral part of good health, but they have lost their focus and integrity. The ball is in their court.
Chris
Laurie, I understand your points I think but I am saying that public consumption of information that can only be assessed by a professional audience has limited value to the public. The general public, as you know, is not qualified to judge clinical info or decide on its relevance to each as an individual. Talk of side effects, interactions etc is only useful in a wider context of understanding what that means for the individual and his or her particular situation. I agree that trust plays a major part but on what basis does the patient decide whether to trust the physician/nurse practitioner/PA/ nurse etc? Many are totally unqualified to judge. As far as the ‘industry’ having lost focus and integrity, that’s a pretty wide accusation. There are some no doubt that have, but many more who turn up every day to do a job, and have no intention of ever misleading the public, of which they are a part.
Lisa Van Syckel
Chris,
Residents of the UK are very respectful,and being gullable,they are not.The UK authorities, took positive steps to protect the children of their country,they banned the off-label use of antidepressants,Were as the US did not.As an American Parent,whose child nearly lost her life to the antidepressant Paxil,would like to put forth this question to you.Who, gives you, or anyone else, the authority to determine what parents should, or shouldnt be told about the safety and efficay of the medicines they give their children.Industry must stop playing Russian roulette with human lives!!!!
Rita
As in every profession there are people good at their jobs, and others not.
In the medical profession, if someone is not good, or honest, lives are lost.
Whether or not the average person is able to fully understand clinical trials, they should be made public, they should be controlled, and people have the right to the information should they want it. Withholding information that means life or death to some people is criminal. GSK has numerous times with held information that took lives. There is no accountability, the FDA has proven ineffective and comes with many conflict of interest scenarios.
As a parent who almost lost their child to paxil, a parent without medical background, yes, had the true clinical trials been available to me it would have sent up a huge red flag. It would have saved my child from the hell she went through. This is fact; I never would have given it to her.
I personally don’t feel the ‘industry’ having lost focus and integrity to be a wide accusation. Inform yourself on the clinical trials, with held data, medical professionals playing with clinical trial reports and weaning out the bad etc. This ‘is’ huge, unfortunately, until someone is touched by a first hand experience that effects a loved one the big picture goes unnoticed by the general public.
Yes, there are amazing doctors out there, I don’t dispute that. Once you enter the field of pharmaceuticals and all attached to it, the industry most certainly has lost focus and integrity.
Laurie
“public consumption of information that can only be assessed by a professional audience has limited value to the public.”
Chris, what reaction to a drug could be so technical that a layperson couldn’t understand? As a nurse I am responsible for making sure that a patient understands what the risks and benefits of every drug that they are taking are made clear to them. If I don’t make that information clear, then I am not doing my job and can be held accountable for that.
If I’m not given complete disclosure of a drugs risks by the manufacturer, I cannot pass that information on.
If a drug has a warning ,that a doctor knows about, and that doctor chooses to not pass on that information to his patient he should be held accountable for that also. A warning not given to those who it may effect is not a warning at all.
This is what I’m looking to happen in prescribing.
The public has access to more information today than ever before. People are “googling” for information, but google shouldn’t have to be used if full disclosure happens in the doctors office.
Now, if Pharma isn’t disclosing everything they know about a drug to even the doctors prescribing, then the whole system breaks down.This is where the trust comes into play. You have doctors prescribing on faulty information, patients taking drugs and having their adverse reactions denied, because the doc has no idea that an adverse reaction like that HAS been found, yet unreported in clinical trial. The latest article out of the New York Times highlights this problem.
I lived my first 45 years of my life believing that the FDA was the gold standard for drug safety. It was only after almost losing my son, that I discovered I was grossly misinformed. The revelation that the FDA looks at 1% of clnical trials presented is a horrible statistic.
The general public are not stupid people. Patient are “intelligent” enough to understand what a drugs risks are, They shouldn’t be given a bottle of pills and sent on their way.
Melody
Laurie–
Many of your observations are covered in the book “Too Profitable To Cure” (website of same name) and author contact info is there. Would you take a look? Freedom of choice, right to informed consent, and failings of the profession, the industry and regulators form a web designed to entrap and enslave patients.
Melody
Laurie–
Many of your observations are covered in the book “Too Profitable To Cure” (website of same name, no spacesdot com) and author contact info is there. Would you take a look? Freedom of choice, right to informed consent, and failings of the profession, the industry and regulators form a web designed to entrap and enslave patients.
Melody
I would ask if Dr. Buse and Dr. Peters are so eager to be recognized for their anti-Avandia stance, why have they failed to take a look back at the insulin-cartel, and the unacknowledged dangers of genetically-engineered insulin. Dr. Buse, as incoming head of ADA, I suspect, will assume the role of mouthpiece for the insulin-cartel. Do doctors like these have some inside information about the superiority of “human insulin” vs natural insulin; if so, I would like to hear it. Otherwise, I would ask them to take a historical look at the product, the proven “lack of need,” its stellar rise to dominance, and ask how it might be related to the current “diabetes epidemic.”
Darcy
When an apple falls on your head, do you recognize the experience as painful because you read about the probability of apples falling, or because you had an experience? Would you have sat under the tree in the first place if your advisor (read doctor) said, “things that hang can hit your head and hurt.” Notice how there’s health enhancing knowledge and warning without any need for qualifying a person as ready to understand gravity relative to the square of the distance, 9.8m/s^2 and all that good stuff?
Let EVERY HUMAN BEING have access to ALL information, and let them live a life of informed experience and discovery. Let every human being share what they know, all levels, so that those who consider themselves “qualified” can not only make new discoveries through personal exchange, but also test what they were told during their qualification. There’s no such thing as an unqualified human being. We’re all qualified to have an experience and be told ahead of time what others have experienced anecdotally and scientifically (human + book).
Part of not doing harm, is empowering people to not harm themselves.
Profit invented loss of transparency in social exchange. Money inspires hiding. Do we really want to live that way? Isn’t it very primitive and childish of society that something as simple as the relative truth, falsely labeled as absolute in industry and academia, something we try to teach to a 2 year old, isn’t modeled or in use anywhere? “Sorry moms, you don’t get to know about the pills you’re giving your kids. You can trust us. We just made billions of dollars.”
If a drug has been known to cause harm, carries a black warning label, it should never be placed inside a bag for you to take home until you’ve been given information on it. Deliberately make eye contact, get a signature, whatever it takes to make that connection of, “you really know what you’re receiving here right? And you realize that the science of the brain is still new and not very well understood, so we still don’t know all of what this drug can do and how it can harm? The labels say it does harm. We’re going on a hope here that it won’t harm you while we take your money.” We need to retire our days of blind trust and switch to personal interest and awareness.
“leave pharmaceutical, therapeutic, and clinical decisions to the professionals.”
That’s like saying if you see someone on fire from having run out of their burning house, you should stand to the side and watch while you wait for the firemen to arrive. Uh no. If someone’s on fire, I’m tossing them the ground for a good roll. “Wait for the qualified messiah” is an old idea that has to be let go of.