If you read my recent post, The Vicissitudes of Kong, you'll know about AbbVie filing suit to prevent the EMA (European Medicines Agency) from gaining access to the data from their trials.
David Healy is asking people to sign his petition, which requests that AbbVie, and InterMune, another pharmaceutical company that has filed suit to prevent access to its data, drop their respective lawsuits.
I'm posting this link to the petition:
Obviously, people need to make their own decisions about whether to sign, but take a look at it, and if you think it has merit, and you're so inclined, you might want to sign it.
Showing posts with label pharmaceutical. Show all posts
Showing posts with label pharmaceutical. Show all posts
Sunday, September 15, 2013
Monday, June 17, 2013
Quiet RIAT
RIAT stands for "Restoring Invisible and Abandoned Trials.
I don't know if it's supposed to be pronounced like "riot", or like "ree-at".
But here's the idea.
Drug companies conduct studies to get new drugs approved, and to convince people to prescribe or request those drugs once they are approved. Do the studies tell the whole story? No. Do the studies always report all the truth about the drug in question, including side effects? No. Do the studies sometimes juke their stats to make their drugs look good? Yes. Are all relevant studies published? No.
It amazes me that in an age when the government routinely spies on random dot citizen with impunity, when everyone is talking about how privacy has gone the way of the Edsel, somehow, Big Pharma has managed to retain its secrets.
But not all its secrets.
Due to things like technology and lawsuits, lots of data are now available to the general public. Specifically, the pharmaceutical industry produces Clinical Study Reports (CSRs), which are hundreds or even thousands of pages long, and include "...an unabridged and detailed summary of the planning, conduct, and results of a clinical trial...Manufacturers submit clinical study reports to the US Food and Drug Administration as part of applications for new drugs. In addition, the FDA typically also requires submission of the protocol and individual participant data. ." (Same link as above).
So when a drug company releases its CSR and data to the public realm, whether voluntarily or by legal requirement, all the information necessary to publish the study becomes available. To the whole wide world.
Now along comes RIAT, with access to 178,000-some pages of data, and says, loud and clear:
HEY! Big Pharma! You have 365 days to republish the study, accurately and fully, so the world can judge the results for itself, Yo! And if you don't republish the study within a year, we'll publish it for you, using your publicly available data, and our own judgement as to what really went on, and what to conclude from the results.
Actually, it's the BMJ, so they say it a lot more politely.
I like a lot of things about this idea. It dovetails nicely with my Open Source post. It holds pharmaceutical companies accountable for their products. It's clever. And it openly acknowledges the problems that may arise, and it accepts that there are many questions to be asked, and not always clear answers:
There's a lot more to it, and the article has a number of links to free papers with titles like, Rethinking credible evidence synthesis, and, Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.
Pretty interesting. Check 'em out!
I don't know if it's supposed to be pronounced like "riot", or like "ree-at".
But here's the idea.
Drug companies conduct studies to get new drugs approved, and to convince people to prescribe or request those drugs once they are approved. Do the studies tell the whole story? No. Do the studies always report all the truth about the drug in question, including side effects? No. Do the studies sometimes juke their stats to make their drugs look good? Yes. Are all relevant studies published? No.
It amazes me that in an age when the government routinely spies on random dot citizen with impunity, when everyone is talking about how privacy has gone the way of the Edsel, somehow, Big Pharma has managed to retain its secrets.
But not all its secrets.
Due to things like technology and lawsuits, lots of data are now available to the general public. Specifically, the pharmaceutical industry produces Clinical Study Reports (CSRs), which are hundreds or even thousands of pages long, and include "...an unabridged and detailed summary of the planning, conduct, and results of a clinical trial...Manufacturers submit clinical study reports to the US Food and Drug Administration as part of applications for new drugs. In addition, the FDA typically also requires submission of the protocol and individual participant data. ." (Same link as above).
So when a drug company releases its CSR and data to the public realm, whether voluntarily or by legal requirement, all the information necessary to publish the study becomes available. To the whole wide world.
Now along comes RIAT, with access to 178,000-some pages of data, and says, loud and clear:
HEY! Big Pharma! You have 365 days to republish the study, accurately and fully, so the world can judge the results for itself, Yo! And if you don't republish the study within a year, we'll publish it for you, using your publicly available data, and our own judgement as to what really went on, and what to conclude from the results.
Actually, it's the BMJ, so they say it a lot more politely.
I like a lot of things about this idea. It dovetails nicely with my Open Source post. It holds pharmaceutical companies accountable for their products. It's clever. And it openly acknowledges the problems that may arise, and it accepts that there are many questions to be asked, and not always clear answers:
There's a lot more to it, and the article has a number of links to free papers with titles like, Rethinking credible evidence synthesis, and, Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.
Pretty interesting. Check 'em out!
Monday, May 27, 2013
Open Source-Please Comment
I have an idea, in very rudimentary form, and I'd like to get peoples' opinions on it.
But first, an amusing anecdote:
The attending who taught me ECT was a character. He'd been doing ECT forever, and his approach was quite old-school. When the patient started to seize, as noted by the twitching toe, he would determine the length of the seizure by counting, 1-Mississippi, 2-Mississippi, 3 Mississippi...
One time, I suggested we look at the clock, and he said, "No, no, this is better." 1-Mississippi was his definition of clinical rigor. Clearly, this was not science.
I read somewhere, some time ago, that the DSM (3?) committee voted on the criteria for MDD. "Those in favor of worthlessness/guilt? Approved! Those in favor of helplessness/hopelessness? Not approved!"
Clearly, this was not science.
But here's the interesting part. How was it determined that 126 was the cutoff for diabetes? I'm not going to look up the history, but I imagine it started with the idea that diabetes was a disease, whose symptoms included ketosis, polyuria, polyphagia, polydypsia, etc. And after seeing many patients with this condition, some clever person figured out that it had something to do with glucose. And later, they realized that if a patient's glucose level is too high, that patient has diabetes. And then "too high" needed to be defined. Presumably, they took a lot of patients who had known diabetes and compared them with normal controls by testing glucose levels. And eventually, they figured out that most patients with diabetes had glucose levels > 126, and most patients without diabetes had levels < 126.
That is science. And it involved a lot of data over a long period of time. Now, granted, they had a test they were looking at-plasma glucose concentration. And there are no convenient lab tests in psychiatry. But there is data.
Not the data you get from a drug-company-sponsored study, where fancy statisticians are hired to produce any desired reality (see, for example, this post). And not the data you get from a 20 person committee voting on a diagnosis.
But what if it was a 200 person committee? Or 2000? Or 20,000? Imagine 20,000 mental health practitioners chiming in on which symptoms they've seen the most. Or which meds they've found most effective. Or least. Or what type of therapy works best for what type of patient. One anecdote is meaningless. But 20,000 anecdotes? Not so meaningless.
I'm talking about the power of the internet. There was a time when the largest number of clinicians you could get in one place was at an APA meeting. Or a survey sent out by snail mail. Now, there's worldwide access at all times. Who needs the DSM when there's the possibility of open source psychiatric data and unlimited discussion?
Would this do anything to determine etiology? No. Not in and of itself, anyway. Would it be valid or accurate? Who knows? People are skeptical about Wikipedia, but is there any more cause for skepticism there than in an old-fashioned encyclopedia article written by one biased individual? Or one closeted committee?
Facebook changed the world by recognizing that a huge collection of connected individuals is a very powerful thing. Why can't we make that idea work to our patients' benefits?
Please comment on this post. I'd like to get a sense of what people imagine this could be like.
But first, an amusing anecdote:
The attending who taught me ECT was a character. He'd been doing ECT forever, and his approach was quite old-school. When the patient started to seize, as noted by the twitching toe, he would determine the length of the seizure by counting, 1-Mississippi, 2-Mississippi, 3 Mississippi...
One time, I suggested we look at the clock, and he said, "No, no, this is better." 1-Mississippi was his definition of clinical rigor. Clearly, this was not science.
I read somewhere, some time ago, that the DSM (3?) committee voted on the criteria for MDD. "Those in favor of worthlessness/guilt? Approved! Those in favor of helplessness/hopelessness? Not approved!"
Clearly, this was not science.
But here's the interesting part. How was it determined that 126 was the cutoff for diabetes? I'm not going to look up the history, but I imagine it started with the idea that diabetes was a disease, whose symptoms included ketosis, polyuria, polyphagia, polydypsia, etc. And after seeing many patients with this condition, some clever person figured out that it had something to do with glucose. And later, they realized that if a patient's glucose level is too high, that patient has diabetes. And then "too high" needed to be defined. Presumably, they took a lot of patients who had known diabetes and compared them with normal controls by testing glucose levels. And eventually, they figured out that most patients with diabetes had glucose levels > 126, and most patients without diabetes had levels < 126.
That is science. And it involved a lot of data over a long period of time. Now, granted, they had a test they were looking at-plasma glucose concentration. And there are no convenient lab tests in psychiatry. But there is data.
Not the data you get from a drug-company-sponsored study, where fancy statisticians are hired to produce any desired reality (see, for example, this post). And not the data you get from a 20 person committee voting on a diagnosis.
But what if it was a 200 person committee? Or 2000? Or 20,000? Imagine 20,000 mental health practitioners chiming in on which symptoms they've seen the most. Or which meds they've found most effective. Or least. Or what type of therapy works best for what type of patient. One anecdote is meaningless. But 20,000 anecdotes? Not so meaningless.
I'm talking about the power of the internet. There was a time when the largest number of clinicians you could get in one place was at an APA meeting. Or a survey sent out by snail mail. Now, there's worldwide access at all times. Who needs the DSM when there's the possibility of open source psychiatric data and unlimited discussion?
Would this do anything to determine etiology? No. Not in and of itself, anyway. Would it be valid or accurate? Who knows? People are skeptical about Wikipedia, but is there any more cause for skepticism there than in an old-fashioned encyclopedia article written by one biased individual? Or one closeted committee?
Facebook changed the world by recognizing that a huge collection of connected individuals is a very powerful thing. Why can't we make that idea work to our patients' benefits?
Please comment on this post. I'd like to get a sense of what people imagine this could be like.
Sunday, December 9, 2012
Abilif-Eyeballs
What's up with the eyeballs in Abilify ads? Like this one:
Are they supposed to be cute?
A pair of eyeballs following around someone taking an antipsychotic. Seriously?
Oh yeah! This isn't an ad for Abilify the antipsychotic. It's an ad for Abilify the antidepressant augmentation med.
And if you watched through the ad, did you notice that 40 of the 90 seconds are spent describing side effects? Okay, you probably didn't bother to count like I did, but you get the idea.
I do not like drug ads on TV. But why?
Is it because they're a blatant manipulation of lay people by Big Pharma? Well, there is that.
Dammit, if pharmaceutical companies are going to manipulate people, then by golly let those people be doctors so we can get free pens and clipboards out of it.
Did you know that the amount of money pharmaceutical companies spend on advertising is 19 times what they spend on research? Huffington Post Link
One figure I found (click here) is 4.8 Billion dollars spent annually on direct to consumer marketing. That doesn't even include pens.
Now, don't get me wrong. I don't hate pharmaceutical companies the way I hate insurance companies. After all, the meds we prescribe have to come from somewhere. And some of them actually work. You can't blame a trillion-dollar conglomerate for tryin' to make a buck. They have products to offer that actually do some people some good. Unlike insurance companies, which offer a product designed to do as little as possible of the job it was purchased to do (i.e. reimburse).
Plus, drug companies will take you out to dinner every now and then. When was the last time United Healthcare bought you so much as a cookie?
I think it bothers me that the ads are misleading. Depression not improving? Here, this'll fix it.
In a recent study (2012), Fava, et al assessed the efficacy of low-dose aripiprazole added to antidepressant therapy (ADT) in 225 major depressive disorder (MDD) patients with inadequate response to prior ADT.They concluded that low-dose (2-5mg) aripiprazole was well-tolerated, but had only marginal efficacy in augmenting ADT.
The commercial never mentioned that. Nor did it state, or even imply, that abilify's original indication was for psychosis. It's as though, just when you thought antidepressants were inadequate to the task of treating depression, a magical pill appeared and saved everyone.
So they're lying. Or exaggerating. But is this really any worse than advertising candy bars, or laundry detergent, or tires?
I think there's a fine line between empowering people to be active participants in their health care, and convincing them they have greater expertise than they do, which is the real way drug ads mislead. You don't need to know much about candy bars to chose one. And maybe you should do a little research when you're purchasing new tires. But you don't need years of education and hands-on experience to make those decisions.
If I needed my car fixed, I wouldn't go to a mechanic and say, "I know what's wrong with my car and which components you need to fix it." And Google is not the great equalizer people would like it to be.
So watch out for those eyeballs.
Are they supposed to be cute?
A pair of eyeballs following around someone taking an antipsychotic. Seriously?
Oh yeah! This isn't an ad for Abilify the antipsychotic. It's an ad for Abilify the antidepressant augmentation med.
And if you watched through the ad, did you notice that 40 of the 90 seconds are spent describing side effects? Okay, you probably didn't bother to count like I did, but you get the idea.
I do not like drug ads on TV. But why?
Is it because they're a blatant manipulation of lay people by Big Pharma? Well, there is that.
Dammit, if pharmaceutical companies are going to manipulate people, then by golly let those people be doctors so we can get free pens and clipboards out of it.
Did you know that the amount of money pharmaceutical companies spend on advertising is 19 times what they spend on research? Huffington Post Link
One figure I found (click here) is 4.8 Billion dollars spent annually on direct to consumer marketing. That doesn't even include pens.
Now, don't get me wrong. I don't hate pharmaceutical companies the way I hate insurance companies. After all, the meds we prescribe have to come from somewhere. And some of them actually work. You can't blame a trillion-dollar conglomerate for tryin' to make a buck. They have products to offer that actually do some people some good. Unlike insurance companies, which offer a product designed to do as little as possible of the job it was purchased to do (i.e. reimburse).
Plus, drug companies will take you out to dinner every now and then. When was the last time United Healthcare bought you so much as a cookie?
I think it bothers me that the ads are misleading. Depression not improving? Here, this'll fix it.
In a recent study (2012), Fava, et al assessed the efficacy of low-dose aripiprazole added to antidepressant therapy (ADT) in 225 major depressive disorder (MDD) patients with inadequate response to prior ADT.They concluded that low-dose (2-5mg) aripiprazole was well-tolerated, but had only marginal efficacy in augmenting ADT.
The commercial never mentioned that. Nor did it state, or even imply, that abilify's original indication was for psychosis. It's as though, just when you thought antidepressants were inadequate to the task of treating depression, a magical pill appeared and saved everyone.
So they're lying. Or exaggerating. But is this really any worse than advertising candy bars, or laundry detergent, or tires?
I think there's a fine line between empowering people to be active participants in their health care, and convincing them they have greater expertise than they do, which is the real way drug ads mislead. You don't need to know much about candy bars to chose one. And maybe you should do a little research when you're purchasing new tires. But you don't need years of education and hands-on experience to make those decisions.
If I needed my car fixed, I wouldn't go to a mechanic and say, "I know what's wrong with my car and which components you need to fix it." And Google is not the great equalizer people would like it to be.
So watch out for those eyeballs.
Subscribe to:
Posts (Atom)