Today I was going to tell you the tale of my son's broken wrist (he is fine now, this happened in January, but the insurance issues are fascinating), but I got distracted thinking about another fascinating subject that many do not understand well: confounding by indication. I especially started thinking about it in the context of how decisions and policies are made, and how not having the right data at the right time leads to this "Titanic effect" for a technology. What do I mean by this? Well, let me explain.
Some say the Titanic sank simply because of poor preparation -- not enough life boats, not enough training on the evacuation procedure, in other words "not enough imagination" to plan for a catastrophe. It was derailed in its course by an entirely predictable natural calamity that had not been planned for adequately, even though the risk was obvious in retrospect. Was this just on of those "unintended consequences" that could have been avoided with more clear vision? Perhaps, but the Titanic is, ahem, water under the bridge. But we can focus on some more mundane and current potential missteps and make some guesses.
Let's talk about medical technologies, and drugs in particular. Let us say that there is a new sepsis drug that has been tested among patients with sepsis but without organ failure. This drug appears to prevent organ failure in a fraction of the treated patients, and also reduces mortality by 6%. The only obstacle to widespread use of this drug is its acquisition cost, which is much higher than what the hospital's critical care pharmacist is used to paying for other drugs. Because of this high cost, the drug, despite being on the formulary, gets administered only to those patients who have developed not one, but two organ failures. The savvy pharmacist looks at the outcomes of these patients and, after comparing them to those of the patients who did not receive the drug, concludes that the new sepsis drug, instead of saving lives, actually kills. The P&T committee discusses this, dumps the drug from the formulary and other hospitals follow suit. What's wrong with this picture?
Several fallacies are at work here, including an overly broad inference of causality and bias. But the most important lesson is to do with confounding: because of its apparent expense, the drug has been niched into a population of patients who a). were not the ones that exhibited the evidence of benefit in the trials, and b). have a very high risk of mortality at baseline. So, not only is it not valid to conclude that the drug killed these patients, but it is not even valid to say that the drug does not work -- it may well work in the populations that it was shown to work in, but not in this, much more ill, population. You see the difference? It is like saying that you umbrella failed to keep you dry when you opened it only after you already got soaked.
So confounding by indication is one reason that drugs "fail" -- they are given to people who are by definition not going to do well, and the confirmation bias pushes us to say see, it's expensive and doesn't work. So how do we overcome this phenomenon and make sure that appropriate patients get access to useful technologies? I believe I have a very simple answer: don't squeeze the toothpaste out of the tube if you don't want to have to cram it back in. Huh?
In other words, do what I always advocate: be ready with the relevant data before the train leaves the station, before the cat gets out of the bag, before the horse gets out of the barn. It is very well known that cognitive biases, once established, are difficult to overcome. The pharmacist's first concern is for being able to use his very limited resources efficiently, and to guard from spending his monthly budget on a potentially useless intervention in a single patient only to be left with no resources to care for all of the other patients. Yet many manufacturers at launch send their reps to the pharmacist with two virtually unrelated stories: one about efficacy and the other about the acquisition price and its impact on his budget. When the drug is expensive, the efficacy pales in comparison to the price tag, and the pharmacist has no choice but to restrict the use of the drug, thereby consigning it to failure by confounding by indication. Sound familiar?
Is there a way to avoid this scenario? I think so. It is self-evident that you have to have good data. The surprising thing is that good data are necessary, but not sufficient: the timing of these data is critical as well. It is easier to help people form an opinion where none exists than to change one that is already there. So, to be successful, the manufacturer with a good technology must have a coherent effectiveness and cost-effectiveness proposition right out of the gate. Not only that, but it is imperative to help the clinician understand what patients might benefit from the technology (no, not all patients should be on your drug). This is the kind of a collaboration that will ultimately benefit all stake holders: 1). Appropriate patients will get the opportunity at better outcomes, 2). The pharmacist will understand up front the value proposition and the potential scope of use, and 3). The manufacturer will profit from providing a beneficial service. Isn't this the intent of all this drug development?
If all this seems all too obvious, it is because this is not rocket science. But why, then, do I see so many companies get into trouble with this very scenario? Is it just the case of "best laid plans" or is it a real blind spot that needs to be illuminated? You tell me. Given the investment that goes into drug development, I think it makes sense to approach this gap earnestly, instead of just shuffling the deck chairs on the Titanic.
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Showing posts with label pharma. Show all posts
Showing posts with label pharma. Show all posts
Tuesday, April 24, 2012
Thursday, December 22, 2011
3 ways to sink a new drug
I don't just rant about methods and evidence -- in my work life I also rant about health economics and outcomes! This is why I was so interested in this post by the health economist Ulf Staginnus called
"New Models for Market Access." I want to give a hat tip to Healtheconomics.com for pointing me here.
The thesis of the article is that we need to refocus our discussion from market access to true innovation in the biopharma sector. There are some priceless quotes here, like this one, for example:
He has this to say about health economics and outcomes and such:
The second problem is that articulating the value proposition of a nascent technology is usually an afterthought. In fact it is self-evident that drug pricing must be fed using the information on the burden of disease, and the impact the new technology can make in mitigating such burden. Unfortunately, time and time again I see companies backing into a price simply in reaction to what their Boards perceive the returns should be. And frequently this is based on the overly optimistic market projections flowing from, you guessed it, market "research."
So, the direct result of all this short-sightedness and business as usual is that even innovative useful products are driven into oblivion because there is no realistic look at what the technology is worth or where best to use it. And fixing the problem after the drug or device is on the market is a much bigger challenge for several reasons. First, the acquisition costs of new technologies are bound to be higher than of those already in use. This puts them at a disadvantage in that they get niched into populations that have much greater burdens of illness and therefore less of a chance of doing well. In other words, they are used as a last ditch therapy, which very rarely ends well. Ironically, these are usually not the populations who were studied in the pre-approval studies, and thus the use turns out to be off-label. But here is the real problem: When these technologies are in the "kitchen sink" category, they will almost always end up looking worse in terms of the outcomes than their older counterparts. And to the untrained eye, or an eye who does not have the time to discern the truth, particularly in the setting of perceived high expenses on the new product, this rings the death toll for the drug. But the reality, of course, is that the abysmal outcomes are the result of confounding by indication, where the drug was inappropriately given to those patients who were very unlikely to benefit from in the first place. But you see how this early lack of attention to the articulation of appropriate populations and health economic data can snowball into failure of a promising therapy.
So, if you want your drug to fail, do the opposite of what I recommend below. In other words DO NOT
1. Develop your market understanding
Do it not from the opinions of a handful of "experts" -- experts will rarely tell you the truth. Instead, do epidemiology studies to understand your population and its subpopulations so as to get the most reasonable idea of the disease.
2. Start thinking about the value proposition early
At the end of a successful Phase 2 program is a good time to do this. The surprise to most companies is how little HEOR studies cost in comparison with their clinical trials program. Yet, as you can see from above, this drop in the ocean can make or break a product.
3. Focus on transparent pricing methods
When pricing the technology, be very very sure that you have all of the ducks in a row, meaning:
a. do understand your market
b. do understand the burden and costs of the disease
c. do understand how your product impacts these costs
d. do price the product to reflect this balance
It is truly embarrassing to have to admit that your price reflects nothing more than the greed of your investors. Trust me, you will not score points with your customers.
Staginnus makes one other important point which I generally agree with:
"New Models for Market Access." I want to give a hat tip to Healtheconomics.com for pointing me here.
The thesis of the article is that we need to refocus our discussion from market access to true innovation in the biopharma sector. There are some priceless quotes here, like this one, for example:
Don't you love it? It is hard to disagree. He also calls for more of a focus on the long-term returns than the short-term (duh!), as well as more internal honesty, or having the courage to stand up to the pathologic internal enthusiasm about a late-stage product that will obviously go nowhere. And all of this is on target.It is amusing, at least to me, to see the continued flood of articles, consultant presentations, blogs, congress announcements, workshops, summits, reorganizations, speeches, etc. all over the place, basically suggesting how the industry just needs to throw a few more people with fancy titles here and there, coupled with slight organizational changes, onto the problem and involve stakeholders and—guess what?!—actually talk to patients and perhaps even payers and all of a sudden, like Alice in Wonderland, everything will be good, after all.The uncomfortable truth is, it won't be. All this “noise” is only good for one thing, paying the bills of the consultants, which is fine, too, as I have been one myself so I can understand. But it will not address the problem the research-based pharmaceutical industry and its employees are facing. Without a substantial increase in R&D productivity, the pharmaceutical industry's survival (let alone its continued growth prospects), at least in its current form, is in great jeopardy.
He has this to say about health economics and outcomes and such:
Of course, you need experience in areas such as HE, outcomes research, pricing, economics, policy, advocacy, etc. and all needs to work in sync and early on and with the payer in mind and, yes, most people have understood that by now. So the problem is essentially not in the capabilities, although some are more advanced than others, but rather in the company cultures.And this, I think, is where I have to disagree with him. In my experience there are glaring deficits in the approach to HEOR within biopharma, though of course there are exceptions to the rule. It starts with the fact that disease burden, and especially its costs, are initially assessed through less than, shall we say, rigorous methods. I have seen this critical information get pieced together through market "research", where 5-10 "thought leaders" are asked for their opinions, and the quantification is based on this tiny non-representative sample of nothing more than guesses. This is a shame because the data usually exist which can give a much more bona fide estimate of the extent of the problem.
The second problem is that articulating the value proposition of a nascent technology is usually an afterthought. In fact it is self-evident that drug pricing must be fed using the information on the burden of disease, and the impact the new technology can make in mitigating such burden. Unfortunately, time and time again I see companies backing into a price simply in reaction to what their Boards perceive the returns should be. And frequently this is based on the overly optimistic market projections flowing from, you guessed it, market "research."
So, the direct result of all this short-sightedness and business as usual is that even innovative useful products are driven into oblivion because there is no realistic look at what the technology is worth or where best to use it. And fixing the problem after the drug or device is on the market is a much bigger challenge for several reasons. First, the acquisition costs of new technologies are bound to be higher than of those already in use. This puts them at a disadvantage in that they get niched into populations that have much greater burdens of illness and therefore less of a chance of doing well. In other words, they are used as a last ditch therapy, which very rarely ends well. Ironically, these are usually not the populations who were studied in the pre-approval studies, and thus the use turns out to be off-label. But here is the real problem: When these technologies are in the "kitchen sink" category, they will almost always end up looking worse in terms of the outcomes than their older counterparts. And to the untrained eye, or an eye who does not have the time to discern the truth, particularly in the setting of perceived high expenses on the new product, this rings the death toll for the drug. But the reality, of course, is that the abysmal outcomes are the result of confounding by indication, where the drug was inappropriately given to those patients who were very unlikely to benefit from in the first place. But you see how this early lack of attention to the articulation of appropriate populations and health economic data can snowball into failure of a promising therapy.
So, if you want your drug to fail, do the opposite of what I recommend below. In other words DO NOT
1. Develop your market understanding
Do it not from the opinions of a handful of "experts" -- experts will rarely tell you the truth. Instead, do epidemiology studies to understand your population and its subpopulations so as to get the most reasonable idea of the disease.
2. Start thinking about the value proposition early
At the end of a successful Phase 2 program is a good time to do this. The surprise to most companies is how little HEOR studies cost in comparison with their clinical trials program. Yet, as you can see from above, this drop in the ocean can make or break a product.
3. Focus on transparent pricing methods
When pricing the technology, be very very sure that you have all of the ducks in a row, meaning:
a. do understand your market
b. do understand the burden and costs of the disease
c. do understand how your product impacts these costs
d. do price the product to reflect this balance
It is truly embarrassing to have to admit that your price reflects nothing more than the greed of your investors. Trust me, you will not score points with your customers.
Staginnus makes one other important point which I generally agree with:
And let's face it, if you need a major workshop and intensive external “coaching” to help define the value of your product … well, there actually is little to none. If it was really good, it would have been obvious from the start. So maybe we ought to stop beating around the bush and move on if there is nothing to be done anymore.There is a nuance here, however, as in most things. Given what I have said above, products are more likely to gut than sell themselves. So, while I agree that you do not need a throng of consultants in suits and hair gel to pollute your offices, you do need to understand how to articulate this value, even when it appears obvious.
Monday, December 20, 2010
Why we need collaborations across healthcare sectors
I want to digress from our recent focus on methods and talk a bit about conflict of interest (COI for short). There has been a lot in the press lately about doctors taking money from the biopharmaceutical manufacturers, and doctors inserting unnecessary hardware into patients' hearts and spines. All of this has been happening against the background of a low hum of an ongoing discussion of what constitutes a COI, how much is too much and for what (for example, can a doc who takes research and education dollars from a manufacturer with an interest in anticoagulation sit on a committee that develops the guidelines for prevention of thromboembolic disease?), and how to mitigate these ubiquitous and pesky COIs.
In some ways watching this discussion has been amusing, while in others it has been downright sad. Medical journals, while insisting that advertising money is OK to take (presumably because the editorial and marketing offices are separated by some sort of a fire wall), though professional societies should not be able to take this tainted education money. Professional societies, on the other hand, are running away from the accusations by tightening their continuing medical education (CME) criteria and scrambling to replace the lavish budgets derived from pharma to develop their coveted evidence-based practice guidelines. And while all the pots are calling all the kettles black, academic researchers are being barred from collaborating with the industry on research projects, and industry researchers are being precluded from presenting their data at professional society meetings. While all the time the public is being whipped into lather about these alleged systematic transgressions, and forced to cheer for the ensuing retribution.
But, like many things in life, and especially stuff that we discuss on this blog, this issue is neither black nor white. Don't take me wrong: I am not condoning the egregious excesses of greed demonstrated by some members of my hallowed profession. If you have been reading my blog for some time, you know that I do not dispute the shameful reality of many breeches of public trust. I am an ardent supporter of exposing these breeches and of harsh punishments that they deserve. This is not what I am talking about here.
I am much more concerned about the one-sided story that we have been hearing about pharma-academic collaborations. Because of the persecutory nature of public opinion, some institutions are now shying away from such collaborations. This attitude is akin to navigating a treacherous road while looking in the rearview mirror. Yes, there have been transgressions, yes there has been greed and even scientific fraud in the name of money. Does this mean that we need to stop everything and come up with an entirely new way of managing these risks? Absolutely! Does this mean that we have to get rid of all pharma-academic collaborations? Absolutely not! In my humble opinion, erecting non-scaleable walls between these two groups is a big mistake. Here is why.
First, let me make a disclaimer: I do have active ongoing collaborations with multiple manufacturers. I do not take speaking or other promotional money, but limit myself to consulting and research grant funding. I also do a good deal of unfunded research, and I have never taken a penny for any of my blogging or blogging-related activities. And here is the crux of the matter: In this world of über-subspecialization, with the expertise being demographically and geographically diffuse, how can we afford not to collaborate across different types of organizations with different types of capabilities? Can we really afford to leave all of therapeutic development in the hands of organizations whose overarching purpose is to make money? And equally importantly, can we afford to continue this fragmented model of medical development without any thought to integration of the needs of all of the stake holders? I think not. Just as we are reaping the fruit of electronic medical record development in isolation from the end-user, so this isolation of research effort will lead to even less coherence in medicine. And unless we are ready to socialize our entire healthcare system, it seems naïve to expect that this one sector will acquiesce and start working outside of our coveted free market for the good of humankind alone.
My readers know that I am not an industry apologist. On the contrary, I have said many times that there has been bad behavior across all the sectors of healthcare, starting with biopharma. But if we want to advance rather than stagnate and regress, we need robust collaborations. We also need higher ethical standards and greater professionalism to keep public's health as our top priority.
There is COI everywhere, and, while financial COI is most visible, it is the more hidden COI that is most insidious. An hidden COI can be intellectual, reputational, ego-driven, career-mediated, etc. It is incumbent on us all in this complex world to ask questions and mitigate any ill effects of any cognitive biases, including those created by COI. Ultimately, as I have begun to realize of late, nothing will replace an educated and empowered patient: This is the only model that can provide appropriate checks and balances for our oftentimes misaligned and perverse incentives, both academic and economic.
In some ways watching this discussion has been amusing, while in others it has been downright sad. Medical journals, while insisting that advertising money is OK to take (presumably because the editorial and marketing offices are separated by some sort of a fire wall), though professional societies should not be able to take this tainted education money. Professional societies, on the other hand, are running away from the accusations by tightening their continuing medical education (CME) criteria and scrambling to replace the lavish budgets derived from pharma to develop their coveted evidence-based practice guidelines. And while all the pots are calling all the kettles black, academic researchers are being barred from collaborating with the industry on research projects, and industry researchers are being precluded from presenting their data at professional society meetings. While all the time the public is being whipped into lather about these alleged systematic transgressions, and forced to cheer for the ensuing retribution.
But, like many things in life, and especially stuff that we discuss on this blog, this issue is neither black nor white. Don't take me wrong: I am not condoning the egregious excesses of greed demonstrated by some members of my hallowed profession. If you have been reading my blog for some time, you know that I do not dispute the shameful reality of many breeches of public trust. I am an ardent supporter of exposing these breeches and of harsh punishments that they deserve. This is not what I am talking about here.
I am much more concerned about the one-sided story that we have been hearing about pharma-academic collaborations. Because of the persecutory nature of public opinion, some institutions are now shying away from such collaborations. This attitude is akin to navigating a treacherous road while looking in the rearview mirror. Yes, there have been transgressions, yes there has been greed and even scientific fraud in the name of money. Does this mean that we need to stop everything and come up with an entirely new way of managing these risks? Absolutely! Does this mean that we have to get rid of all pharma-academic collaborations? Absolutely not! In my humble opinion, erecting non-scaleable walls between these two groups is a big mistake. Here is why.
First, let me make a disclaimer: I do have active ongoing collaborations with multiple manufacturers. I do not take speaking or other promotional money, but limit myself to consulting and research grant funding. I also do a good deal of unfunded research, and I have never taken a penny for any of my blogging or blogging-related activities. And here is the crux of the matter: In this world of über-subspecialization, with the expertise being demographically and geographically diffuse, how can we afford not to collaborate across different types of organizations with different types of capabilities? Can we really afford to leave all of therapeutic development in the hands of organizations whose overarching purpose is to make money? And equally importantly, can we afford to continue this fragmented model of medical development without any thought to integration of the needs of all of the stake holders? I think not. Just as we are reaping the fruit of electronic medical record development in isolation from the end-user, so this isolation of research effort will lead to even less coherence in medicine. And unless we are ready to socialize our entire healthcare system, it seems naïve to expect that this one sector will acquiesce and start working outside of our coveted free market for the good of humankind alone.
My readers know that I am not an industry apologist. On the contrary, I have said many times that there has been bad behavior across all the sectors of healthcare, starting with biopharma. But if we want to advance rather than stagnate and regress, we need robust collaborations. We also need higher ethical standards and greater professionalism to keep public's health as our top priority.
There is COI everywhere, and, while financial COI is most visible, it is the more hidden COI that is most insidious. An hidden COI can be intellectual, reputational, ego-driven, career-mediated, etc. It is incumbent on us all in this complex world to ask questions and mitigate any ill effects of any cognitive biases, including those created by COI. Ultimately, as I have begun to realize of late, nothing will replace an educated and empowered patient: This is the only model that can provide appropriate checks and balances for our oftentimes misaligned and perverse incentives, both academic and economic.
Wednesday, October 20, 2010
Recession as an experiment in value of treatments
This is going to be short and sweet.
Pharmalot reported two days ago that abandonment rate for all new prescriptions for brand-name drugs has reached nearly 10%. This should worry Pharma, but not for the reasons that they think. Yes, this means at least a short-to-medium term hit to their revenues. But more importantly, if this trend persists for a meaningful amount of time, it provides an opportunity for healthcare researchers to establish the true value (or lack thereof) of many of the routine drugs prescribed to the US population. What I mean is, we can examine what happens to health trends, and even to specific diseases, while patients are not taking the medications that are considered so vital for their well-being. If we do not see a rise in untoward events, or, better yet, if we see that our public's health is actually better without these meds, that will deal a significant blow to the idea of "a pill for everything". Alternatively we may learn that these meds are truly vital, and this finding should certainly impact our debate about access to them.
Of course, there will be objections. The methods for mining these effects may not be solidly hypothesis-testing, the time in question may not be enough to detect any meaningful changes, and, our favorite, the causality will be difficult to establish. All of the this notwithstanding, this period of time should provide a very interesting natural experiment in the overall value of our treatments today.
Hat tip to @AHCJ_Pia for a ink to this story here.
Pharmalot reported two days ago that abandonment rate for all new prescriptions for brand-name drugs has reached nearly 10%. This should worry Pharma, but not for the reasons that they think. Yes, this means at least a short-to-medium term hit to their revenues. But more importantly, if this trend persists for a meaningful amount of time, it provides an opportunity for healthcare researchers to establish the true value (or lack thereof) of many of the routine drugs prescribed to the US population. What I mean is, we can examine what happens to health trends, and even to specific diseases, while patients are not taking the medications that are considered so vital for their well-being. If we do not see a rise in untoward events, or, better yet, if we see that our public's health is actually better without these meds, that will deal a significant blow to the idea of "a pill for everything". Alternatively we may learn that these meds are truly vital, and this finding should certainly impact our debate about access to them.
Of course, there will be objections. The methods for mining these effects may not be solidly hypothesis-testing, the time in question may not be enough to detect any meaningful changes, and, our favorite, the causality will be difficult to establish. All of the this notwithstanding, this period of time should provide a very interesting natural experiment in the overall value of our treatments today.
Hat tip to @AHCJ_Pia for a ink to this story here.
Monday, February 1, 2010
Health Economics and Outcomes Research: Too little too late?
So I went to this meeting in Washington, DC, last week, to be a part of the conversation on the value of HEOR in the industry. It was a great meeting, with about 50 attendees, most of whom are intimately involved in HEOR in their every-day lives. It was also somewhat spooky. None of the presenters had shared thoughts prior to the meeting. Yet everyone's message was oddly aligned: we need more quality HEOR studies earlier in technology development.
There was broad consensus that most companies do not have a good understanding of the role, methodologies, or value of HEOR within their development programs. And while clinical trialists are a well accepted asset to the industry, HEOR groups still tend to be the red-headed step children. They have little buy-in from other departments and minimal support from the leadership, and their output is viewed with suspicion. To be sure, there are companies who understand the role of HEOR, and these are the success stories. But majority are still in the dark.
This situation must change, and here are some of the compelling reasons why. While 20 years ago all of the emphasis in drug development was on the FDA approval, today, in our economically constrained healthcare system, no approved technology can succeed without understanding what value it brings to the table over what is already available on the market. No longer can marketers employ smoke and mirrors to develop the "winning" proposition. I would argue that, in general, the industry cannot afford to lag in its understanding of economic arguments behind the payor community.
I have always argued that manufacturers need to be the biggest experts on the diseases they are pursuing and their treatments. This by necessity must include the value proposition of their technologies beyond the statistically significant improvements over placebo required by the FDA for approval. We must develop objective milestones by which to judge worthiness of technologies in development at every point in the development process. Those who do, will adapt to and succeed in this atmosphere of cost controls. Those who do not do so at their own peril. As scientists, citizens, consumers and investors, we should make sure that manufacturers are engaging in this ongoing evaluation of their wares with a critical eye to what value they intend to bring to the society.
There was broad consensus that most companies do not have a good understanding of the role, methodologies, or value of HEOR within their development programs. And while clinical trialists are a well accepted asset to the industry, HEOR groups still tend to be the red-headed step children. They have little buy-in from other departments and minimal support from the leadership, and their output is viewed with suspicion. To be sure, there are companies who understand the role of HEOR, and these are the success stories. But majority are still in the dark.
This situation must change, and here are some of the compelling reasons why. While 20 years ago all of the emphasis in drug development was on the FDA approval, today, in our economically constrained healthcare system, no approved technology can succeed without understanding what value it brings to the table over what is already available on the market. No longer can marketers employ smoke and mirrors to develop the "winning" proposition. I would argue that, in general, the industry cannot afford to lag in its understanding of economic arguments behind the payor community.
I have always argued that manufacturers need to be the biggest experts on the diseases they are pursuing and their treatments. This by necessity must include the value proposition of their technologies beyond the statistically significant improvements over placebo required by the FDA for approval. We must develop objective milestones by which to judge worthiness of technologies in development at every point in the development process. Those who do, will adapt to and succeed in this atmosphere of cost controls. Those who do not do so at their own peril. As scientists, citizens, consumers and investors, we should make sure that manufacturers are engaging in this ongoing evaluation of their wares with a critical eye to what value they intend to bring to the society.
Tuesday, September 22, 2009
What should we do with scientific ghost writing?
Ghostwriting in peer-reviewed healthcare literature has been gaining quite a bit of attention. PLoS has even created a public web site to document this deplorable practice by one pharmaceutical manufacturer. But what is this really all about? Is it another tempest in a teapot or a dire threat to scientific integrity? The answer is probably a little bit of both.
Before going further, a couple of disclaimers. I have published a number of studies supported with research funding from manufacturers. In only two instances I had manuscript preparation assistance from a medical writer, and each was acknowledged in the paper. I generally do not like having someone else draft the paper, even a co-author, and prefer to do so myself (control issues, clearly). I also agree that having a paper written by a medical writer and slapping an academic's name on it willi-nilli is an indefensible practice. To be sure, it is indefensible on the parts of both the sponsor and the academic, and as such should be systematically routed out.
Now that we have gotten that out of the way, let's focus on the topic at hand. Here is the definition of a ghostwriter from my favorite populist source, Wikipedia:
Consider this: manufacturer organizations are not monolithic. It is unfortunate that sales and marketing departments are usually oversized, powerful and most visible. Less visible are R&D groups, Clinical Affairs divisions responsible for Phases 1-3 work, and Medical Affairs departments, whose role is to shepherd the post-approval clinical development. It is the Medical Affairs, staffed by healthcare professionals including physicians, pharmacists and others, that primarily interacts with academics to develop ideas that presumably have both, academic integrity and strategic merit for the company. Smart companies understand the importance of having a firewall between the sales and marketing organizations and the Medical Affairs in order to safeguard against marketing abuses couched as science. Under these circumstances, even if a paper starts out within the walls of the company, there has been a heavy imprimatur of the academic collaborators, who ultimately, along with the company authors, take full responsibility for the content of the publication. My point is that not all papers "commissioned" by the industry need to be thrown out.
But what is the role of a medical writer in these endeavors? In my experience, medical writers develop an outline and the first draft of the manuscript based on the data at hand. The quality of this draft can be quite variable depending on the writer's experience. An ideal medical writer is not only knowledgeable about the particular field of investigation, but also knows how to write. Unfortunately, these two criteria are rarely met either singly or together. So, the draft that the authors get usually goes from incoherent to rambling and requires a great deal of intervention at both the scientific and the writing levels. So, if the implication is that the papers get accepted into high impact journals as written by the medical writers without much shaping and editing by the academics, there is something very wrong with these journals' review practices: it is easy to spot an unedited piece of hired writing a mile away!
The World Association of Medical Editors defines ghostwriting thus:
So, what is the sum total here? So long as there is a profit motive on the part of the manufacturers (sorry, but this is the way capitalism works today, right or wrong), they will have a hand in what gets funded. Short of scrapping the pharmaceutical business model as it exists today, we need to come up with transparent best practices that everyone can live with. Companies do and will commission papers. It is unwise for the sales and marketing departments to be the originators of these ideas because of the unmitigated conflict of interest. It is best for Medical Affairs professionals, insulated from sales and marketing, to interact with the academic experts to develop and execute studies and reporting of the data. Medical writers should be used as such only if they bring writing and content expertise to the table, and they need to be acknowledged either as a co-author (provided they meet the criteria) or as someone who has made a contribution to the drafting of the manuscript. If they are unable to contribute usefully, they should be used only for such administrative tasks as formatting the manuscript and references, collating comments and submitting the paper.
On their part, journals need to set higher standards for the reporting, disclosure and reviewers' comments. Editors and reviewers should be on alert for poorly written review papers with a marketing message -- from what I have seen, these are just not that subtle. Ultimately, the responsibility for the integrity of scientific discourse lies with all of the stakeholders. Lest we blow our scientific reputations with the public, we have got to fix what is wrong and come up with a solution incorporating those pieces that work and do not compromise our professional ethics. We do not need to throw the baby out with the bath water; a rational solution may be much closer than we think.
Before going further, a couple of disclaimers. I have published a number of studies supported with research funding from manufacturers. In only two instances I had manuscript preparation assistance from a medical writer, and each was acknowledged in the paper. I generally do not like having someone else draft the paper, even a co-author, and prefer to do so myself (control issues, clearly). I also agree that having a paper written by a medical writer and slapping an academic's name on it willi-nilli is an indefensible practice. To be sure, it is indefensible on the parts of both the sponsor and the academic, and as such should be systematically routed out.
Now that we have gotten that out of the way, let's focus on the topic at hand. Here is the definition of a ghostwriter from my favorite populist source, Wikipedia:
A ghostwriter is a professional writer who is paid to write books, articles, stories, reports, or other texts that are officially credited to another person. Celebrities, executives, and political leaders often hire ghostwriters to draft or edit autobiographies, magazine articles, or other written material. In music, ghostwriters are used in film score composition, as well as in pop music such as Top 40, country, and hip-hop. The ghostwriter is sometimes acknowledged by the author or publisher for his or her writing services. [emphasis mine]Clearly, ghostwriting is a pervasive and acceptable practice in literature, music, politics and even journalism. So, why is there such a furor over it in medicine? Well, the answer is "bias". Here is an example cited by the PLoS editors of an illustrative correspondence between a sponsor and the medical writing company:
An email from a writer employed by the medical writing company, DesignWrite, to employees of Wyeth, the company that performed the study, and Parthenon (another medical writing company) on November 10, 2003 concerning manuscripts on Totelle (a brand of hormone replacement therapy manufactured by Wyeth) tells the story concisely. “Thanks to all who have reviewed and approved the manuscripts… I have received no word on authors for the Totelle 2 mg bone manuscript P3(2), and need input on this matter before this manuscript can move forwards.” [our emphasis added]On its own, the quote is damning on the one hand, but totally explicable on the other: in large trials not all investigators are listed as authors on the paper, and this my be what the e-mail is querying. I do not think that this was the case here, however. As for generating review papers with authorship to be determined at a later date, the case is less clear. Should the manufacturer be able to be the originator of an idea on what information gaps need to be filled? Or should these always come from academics?
Consider this: manufacturer organizations are not monolithic. It is unfortunate that sales and marketing departments are usually oversized, powerful and most visible. Less visible are R&D groups, Clinical Affairs divisions responsible for Phases 1-3 work, and Medical Affairs departments, whose role is to shepherd the post-approval clinical development. It is the Medical Affairs, staffed by healthcare professionals including physicians, pharmacists and others, that primarily interacts with academics to develop ideas that presumably have both, academic integrity and strategic merit for the company. Smart companies understand the importance of having a firewall between the sales and marketing organizations and the Medical Affairs in order to safeguard against marketing abuses couched as science. Under these circumstances, even if a paper starts out within the walls of the company, there has been a heavy imprimatur of the academic collaborators, who ultimately, along with the company authors, take full responsibility for the content of the publication. My point is that not all papers "commissioned" by the industry need to be thrown out.
But what is the role of a medical writer in these endeavors? In my experience, medical writers develop an outline and the first draft of the manuscript based on the data at hand. The quality of this draft can be quite variable depending on the writer's experience. An ideal medical writer is not only knowledgeable about the particular field of investigation, but also knows how to write. Unfortunately, these two criteria are rarely met either singly or together. So, the draft that the authors get usually goes from incoherent to rambling and requires a great deal of intervention at both the scientific and the writing levels. So, if the implication is that the papers get accepted into high impact journals as written by the medical writers without much shaping and editing by the academics, there is something very wrong with these journals' review practices: it is easy to spot an unedited piece of hired writing a mile away!
The World Association of Medical Editors defines ghostwriting thus:
Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. WAME considers ghost authorship dishonest and unacceptable. Ghost authors generally work on behalf of companies, or agents acting for those companies, with a commercial interest in the topic, and this compounds the problem. For example, a writer employed by a commercial company may prepare an article, then invite an expert in the field to submit the work, perhaps with minor revisions, under his or her own name. The submitting author may be paid, directly or indirectly, for this service. In other circumstances, investigators may pay a professional writer to help them prepare their article but not mention this assistance, gaining credit for writing they have not done. Although editors seek to avoid publication of ghost written articles, these articles are often very difficult to detect.Again, I have to say that ghost writing that I have been privy to as a reviewer is really not that hard to spot. But of course this view may be the result of misclassification on my part, as those papers that are well written do not elicit the same suspicion from me. I guess to be more accurate I need to state that at least some ghost written papers are easy to spot.
So, what is the sum total here? So long as there is a profit motive on the part of the manufacturers (sorry, but this is the way capitalism works today, right or wrong), they will have a hand in what gets funded. Short of scrapping the pharmaceutical business model as it exists today, we need to come up with transparent best practices that everyone can live with. Companies do and will commission papers. It is unwise for the sales and marketing departments to be the originators of these ideas because of the unmitigated conflict of interest. It is best for Medical Affairs professionals, insulated from sales and marketing, to interact with the academic experts to develop and execute studies and reporting of the data. Medical writers should be used as such only if they bring writing and content expertise to the table, and they need to be acknowledged either as a co-author (provided they meet the criteria) or as someone who has made a contribution to the drafting of the manuscript. If they are unable to contribute usefully, they should be used only for such administrative tasks as formatting the manuscript and references, collating comments and submitting the paper.
On their part, journals need to set higher standards for the reporting, disclosure and reviewers' comments. Editors and reviewers should be on alert for poorly written review papers with a marketing message -- from what I have seen, these are just not that subtle. Ultimately, the responsibility for the integrity of scientific discourse lies with all of the stakeholders. Lest we blow our scientific reputations with the public, we have got to fix what is wrong and come up with a solution incorporating those pieces that work and do not compromise our professional ethics. We do not need to throw the baby out with the bath water; a rational solution may be much closer than we think.
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