"Dear Howard," begins the e-mail, "here at Cutting Edge Information, we have done extensive primary research about some of the hurdles and roadblocks you may be facing as a sales representative or sales manager at University of Texas Medical Branch." These nice people want me to download a free summary of their report, "Reinventing Pharmaceutical Sales Forces."
I have to search around a fair amount to find that if I wanted to actually buy the complete report, it would cost me $7695 for a single-user license or $23,995 for an unlimited license. So it's not too surprising that the free summary gives very little away. What's there, however, may be a bit of a further clue as to what the drug industry is doing in the face of recent changes and pressures on its marketing model.
The summary starts out by citing the Wall Street Journal that after reaching a high of 100,000 just after 2000, we can expect the number of drug reps in the US to drop to 70,000 by 2015. Different companies, it seems are all over the map--a couple have drastically cut their force by as much as 50-60%, with the average being around 15%.
How can they make these big cuts and still peddle drugs? The big discovery seems to be that there were way too many drug reps during the peak season, and they were tripping over each other streaming in and out of the docs' offices and in the process, getting the docs ticked off. I gather that the fancy name for that was "mirroring" and the industry has decided that less mirroring is better. "The arms race of the previous decade is dead," pronounces the summary, referring to the time period when it seemed an article of faith in the industry that simply hiring more reps than your competitor was a guarantee of success.
If you don't "mirror," then what do you do? Two things it seems. First, while companies differ a lot on how much and how they are using electronic detailing, most seem to be moving as fast as they can in that direction, to supplement rather than replace face time between rep and doc. Second is the good old bread-and-buttter of detailing-- real, personalized and persistent attention to the docs (and especially the office staff). The summary gushes: "At still another interviewed company, drug reps who maintain one-to-one relationships with targets are greeted like 'rock stars' within the physicians' offices. On a recent ride-along with a rep, everyone within the doctor's office knew the rep by name and was excited to see him. There was no hint of 'the doctor's busy, so come back later.'"
With all this back to the future, you might wonder--what is changing on drug reps' compensation packages? And what impact have the most recent (2009) "ethics" rules from PhRMA had on the reps' operations? The full report answers those question, if anyone cares to shell out the 7-grand-plus to read it. I'd like especially to know about the latter question as the peer-reviewed medical literature, so far as I know, has been silent on that topic.
In past posts I have opined that Pharma really has discovered no alternative to the traditional rep model, which consists of making the doc believe that you're a good buddy and not a sales person, and If You Feed Them They Will Come. From what I can see of the free portion of this "Cutting Edge" report, that does not seem to have changed, arms race or no arms race. So if medicine ever wishes to reassert its professionalism and get out from under the cloud of having our clinical decisions distorted by commercial marketing, the answer is still, just say NO to drug reps. The report seems to hint that we have a really hard time doing that.
Wednesday, September 12, 2012
Monday, September 10, 2012
China and Unsafe Drugs--Any Progress Made?
I have in the past blogged about drug safety issues with U.S. companies buying critical drug ingredients from unregulated and uninspected Chinese factories, such as: http://brodyhooked.blogspot.com/2010/08/policing-unsafe-drugs-toothless-system.html and http://brodyhooked.blogspot.com/2009/01/outsourcing-of-drug-supply-market.html. Our friends over at the Health Care Renewal blog have kindly alerted me to a recent article from Reuters updating us on this issue: http://www.reuters.com/article/2012/08/28/us-china-pharmaceuticals-idUSBRE87R0OD20120828.
Time out for a bit of history. In HOOKED I recounted a story well known to all historians of American pharmaceuticals--how Massengill and Company, in Tennessee, killed more than 100 people in 1937 with a new formulation of the miracle antibiotic, sulfanilamide. Massengill decided people might like the drug in the form of a syrup, and set their chemist to find a nice vehicle that would dissolve the drug and create a smooth texture on the palate. The chemist came up with diethylene glycol--the stuff they make antifreeze with. Which happens not to be good for you or your kidneys. The result of this disaster was new Federal legislation giving the FDA for the first time the authority to demand proof that a drug was safe before it could be marketed. (It took thalidomide in the 1960s to force the next step, that drugs had to be proven to be both safe and effective.)
That, as I said, was in 1937. So what are we to think of the fact (according to the Reuters article) that in 2006, about 100 people died in Panama from a cough syrup made with a Chinese-manufactured sweetener that contained diethylene glycol? Besides the fact that dead people in Panama are not worthy of being covered in the US news media?
There are a number of important points made in the article, but perhaps the bottom-line message is that US drug firms are getting a bit cagier about buying impure chemicals from shady Chinese factories. Some Chinese firms are certified by Good Manufacturing Practice, an internationally recognized standard, and US companies can if they wish do business selectively with those firms (as several drug companies told Reuters). So the unsafe drugs are now being shunted selectively to poorer countries, with Africa taking up the brunt of the traffic.
One thing that has not changed is our dependence on China to manufacture the chemicals that go into drugs (called APIs). Reuters quotes Guy Villax, a Portuguese drug executive: "If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty."
Time out for a bit of history. In HOOKED I recounted a story well known to all historians of American pharmaceuticals--how Massengill and Company, in Tennessee, killed more than 100 people in 1937 with a new formulation of the miracle antibiotic, sulfanilamide. Massengill decided people might like the drug in the form of a syrup, and set their chemist to find a nice vehicle that would dissolve the drug and create a smooth texture on the palate. The chemist came up with diethylene glycol--the stuff they make antifreeze with. Which happens not to be good for you or your kidneys. The result of this disaster was new Federal legislation giving the FDA for the first time the authority to demand proof that a drug was safe before it could be marketed. (It took thalidomide in the 1960s to force the next step, that drugs had to be proven to be both safe and effective.)
That, as I said, was in 1937. So what are we to think of the fact (according to the Reuters article) that in 2006, about 100 people died in Panama from a cough syrup made with a Chinese-manufactured sweetener that contained diethylene glycol? Besides the fact that dead people in Panama are not worthy of being covered in the US news media?
There are a number of important points made in the article, but perhaps the bottom-line message is that US drug firms are getting a bit cagier about buying impure chemicals from shady Chinese factories. Some Chinese firms are certified by Good Manufacturing Practice, an internationally recognized standard, and US companies can if they wish do business selectively with those firms (as several drug companies told Reuters). So the unsafe drugs are now being shunted selectively to poorer countries, with Africa taking up the brunt of the traffic.
One thing that has not changed is our dependence on China to manufacture the chemicals that go into drugs (called APIs). Reuters quotes Guy Villax, a Portuguese drug executive: "If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty."
Ethics (or Lack Thereof) and Post-Marketing Studies
As I noted in HOOKED, and as has been here documented, all too often the FDA approves a new drug contingent upon the company doing a post-marketing study to address outstanding safety or other concerns, and the study never gets done. So you might imagine that the actual conduct of such a study would be an ethically good thing. Unforunately this seems not always to be the case, as discovered by a committee of the Institute of Medicine that was called together by the FDA to look at a study of rosiglitazone (Avandia). Three members of the IOM committee reported on their ethical findings in last week's New England Journal (subscription required).
I have blogged a good deal about the rosiglitazone saga (most recently, http://brodyhooked.blogspot.com/2012/06/worshiping-at-altar-of-innovation-aka.html). The study that the IOM committee addressed was called TIDE, for Thiazolidinedione Intervention with Vitamin D Evaluation, designed to compare long-term cardiovascular outcomes in diabetic patients on two different, related drugs--rosiglitazone and pioglitazone (Actos). TIDE was done in the face of existing information suggesting that rosigolitazone increased the risk of heart problems in a way that pioglitazone did not. By the time TIDE was inaugurated, clinical practice was already starting to shift away from the use of rosiglitazone in diabetes and toward pioglitazone, for the small number of patients who actually had need for a drug in this class anyway. (Drugs in this class lower blood sugar but have never been shown to have long-term, beneficial effects on major complications of diabetes, which is the whole reason to treat Type II diabetes.)
The IOM committee looked especially at two questions regarding TIDE, first, the adequacy of the consent process, and second, the adequacy of the review that was conducted by the 480 IRBs (research review committees) that all approved the trial at their respective institutions. First, the consent stank (my term not the authors'). Patients should have been told that they were at risk of getting a drug that had already been shown to be potentially dangerous, and that there might be no need for the study since clinical practice was already changing even without the results--in short, they should have been given a consent form that would have discouraged all reasonable people from being in the study at all. The consent process softpedaled all these issues.
One of the reasons that the consent process stank was related to the study design. The TIDE investigators (reporting on their trial which apparently was stopped for regulatory reasons, presumably when the IOM committee was called in to referee) noted two areas of "uncertainty" regarding the two diabetes drugs--heart effects and a relationship between Vitamin D and cancer. That latter issue presumably justified sticking in a Vitamin D component which had nothing to do with heart effects, but trying to explain about the Vitamin D in the consent process could easily have confused research subjects and diverted attention away from the heart risks. If one were inclined to be paranoid about a study designed by industry in hopes of exonerating a suspected unsafe drug, one might think that was not entirely coincidental.
On the issue of the IRB oversight, the IOM committee was perhaps more circumspect than they might have been. Rather than decide that these 480 IRBs were all of them incompetent, they preferred to imagine that they were simply not fully informed of the rationale for the study. Had they been so informed, the committee imagined that they would have realized that even if there had been decent consent (and of course there wasn't), the study would have been questionable because subjects were being put at serious risk to establish a fact that was already known and that was uinlikely to change clinical practice. The committee went on to say some wise things about the circumstances when FDA post-marketing studies are more or less justifiable.
The IOM committee made clear that when the FDA orders a drug company to do a post-marketing study, and a study is then conducted that is ethically unsound, the blame cannot be sloughed off on the drug company; the FDA has to share in the ethical responsibility. The lesson for the FDA seems to be--if you find an unsafe drug on the market, deal with it; don't kick the can down the road by pretending that you cannot do anything without more data, if getting the further data would entail doing unethical research.
Full disclosure: I am a member of the IOM but had nothing to do with this committee.
Mello MM, Goodman SN, Faden RR. Ethical considerations in studying drug safety--the Institute of Medicine report. New England Journal of Medicine 367:959-964, September 6, 2012.
Punthakee Z, Bosch J, Dagenais G, et al. Design, history, and results of the Thiazolidine Intervention with Vitamin D Evaluation (TIDE) randomised controlled trial. Diabetologia 55:36-45, 2012.
I have blogged a good deal about the rosiglitazone saga (most recently, http://brodyhooked.blogspot.com/2012/06/worshiping-at-altar-of-innovation-aka.html). The study that the IOM committee addressed was called TIDE, for Thiazolidinedione Intervention with Vitamin D Evaluation, designed to compare long-term cardiovascular outcomes in diabetic patients on two different, related drugs--rosiglitazone and pioglitazone (Actos). TIDE was done in the face of existing information suggesting that rosigolitazone increased the risk of heart problems in a way that pioglitazone did not. By the time TIDE was inaugurated, clinical practice was already starting to shift away from the use of rosiglitazone in diabetes and toward pioglitazone, for the small number of patients who actually had need for a drug in this class anyway. (Drugs in this class lower blood sugar but have never been shown to have long-term, beneficial effects on major complications of diabetes, which is the whole reason to treat Type II diabetes.)
The IOM committee looked especially at two questions regarding TIDE, first, the adequacy of the consent process, and second, the adequacy of the review that was conducted by the 480 IRBs (research review committees) that all approved the trial at their respective institutions. First, the consent stank (my term not the authors'). Patients should have been told that they were at risk of getting a drug that had already been shown to be potentially dangerous, and that there might be no need for the study since clinical practice was already changing even without the results--in short, they should have been given a consent form that would have discouraged all reasonable people from being in the study at all. The consent process softpedaled all these issues.
One of the reasons that the consent process stank was related to the study design. The TIDE investigators (reporting on their trial which apparently was stopped for regulatory reasons, presumably when the IOM committee was called in to referee) noted two areas of "uncertainty" regarding the two diabetes drugs--heart effects and a relationship between Vitamin D and cancer. That latter issue presumably justified sticking in a Vitamin D component which had nothing to do with heart effects, but trying to explain about the Vitamin D in the consent process could easily have confused research subjects and diverted attention away from the heart risks. If one were inclined to be paranoid about a study designed by industry in hopes of exonerating a suspected unsafe drug, one might think that was not entirely coincidental.
On the issue of the IRB oversight, the IOM committee was perhaps more circumspect than they might have been. Rather than decide that these 480 IRBs were all of them incompetent, they preferred to imagine that they were simply not fully informed of the rationale for the study. Had they been so informed, the committee imagined that they would have realized that even if there had been decent consent (and of course there wasn't), the study would have been questionable because subjects were being put at serious risk to establish a fact that was already known and that was uinlikely to change clinical practice. The committee went on to say some wise things about the circumstances when FDA post-marketing studies are more or less justifiable.
The IOM committee made clear that when the FDA orders a drug company to do a post-marketing study, and a study is then conducted that is ethically unsound, the blame cannot be sloughed off on the drug company; the FDA has to share in the ethical responsibility. The lesson for the FDA seems to be--if you find an unsafe drug on the market, deal with it; don't kick the can down the road by pretending that you cannot do anything without more data, if getting the further data would entail doing unethical research.
Full disclosure: I am a member of the IOM but had nothing to do with this committee.
Mello MM, Goodman SN, Faden RR. Ethical considerations in studying drug safety--the Institute of Medicine report. New England Journal of Medicine 367:959-964, September 6, 2012.
Punthakee Z, Bosch J, Dagenais G, et al. Design, history, and results of the Thiazolidine Intervention with Vitamin D Evaluation (TIDE) randomised controlled trial. Diabetologia 55:36-45, 2012.
Sunday, September 9, 2012
A Telling Anecdote about Regulatory Capture and Medical Device Safety
Thanks to an exchange of e-mails on a list that includes journalists Jeanne Lenzer and Shannon Brownlee (whose great work I've previously blogged about), I was directed to an article (subscription required) that I failed to make not of when it came out nearly two years ago. It provides useful background to an issue that has become even more heated this last year, the medical device safety oversight problem (see for example: http://brodyhooked.blogspot.com/2011/10/more-on-device-industry-from-aslme-coi.html).
Lenzer and Brownlee looked in depth at the vagus nerve stimulator manufactured by Cyberonics, a device in which a pacemaker-type pack is surgically inserted near the collarbone, and electrodes are wrapped around the vagus nerve in the neck. The device was intended at first for a select population of patients with a particular type of epilepsy that's resistant to all drug treatment. Like many devices and drugs (and in keeping with the Inverse Benefit Law, http://brodyhooked.blogspot.com/2011/03/synthesis-why-drug-industry-tries-to.html), once having gotten the camel's nose into the tent, Cyberonics is now claiming that the stimulator can be used for a large number of other conditions, notably depression, and perhaps obesity and traumatic brain injury (stay tuned for hair loss and bad breath). All such uses rely on the purported safety of the device, which is what Lenzer and Brownlee zeroed in on.
In 1997, Cyberonics went to the FDA to get initial approval of the stimulator for epilepsy. They presented three studies to document the device's effectiveness and safety. One review panelist noted that 17 of the 1000 subjects who'd had the device implanted had died, and asked what was up with that. The explanation offered by the company and other panelists is that people who have that sort of hard-to-treat epilepsy have a high death rate because periodically those seizures cause cardiac and respiratory arrest. So deaths were due to the disease and not the device.
The FDA bought this explanation but added a caveat--Cyberonics got approval conditionally upon conducting a post-marketing surveillance study to address the concern about possible excess deaths.This, as Lenzer and Browlnee explain, is not an unusual measure--the studies needed to lead to drug or device approval are often, of necessity, too small to detect rare but serious adverse effects, and only after a drug or device is more widely used may such effects become apparent.
But here's where the story gets interesting. Lenzer and Brownlee then went after the data accumulated by the company during this mandated post-marketing study phase. They found several very worrisome things. First, there were at least isolated reports of deaths or near-misses that seemed quite clearly to be due to the device. (One patient who survived was observed to have his heart stop at exactly the intervals at which the stimulator fired, and the heart stoppages ceased with the device was turned off.) When asked how many of these events had occurred, or how often, Cyberonics said they didn't know, because mortality statistics were not one of the planned endpoints in any of its trials. And despite the fact that the FDA had ordered these studies because of concerns about mortality, no one at the FDA seemed the least bit worried about the fact that Cyberonics had set up its studies deliberately to exclude mortality data.
For many years, British sociologist John Abraham has written about regulatory capture--what happens when a government agency that is supposed to regulate an industry ends up becoming so closely tied to industry that it becomes a tool rather than a watchdog. When the Institute of Medicine weighed in on how inadequate the current regulations are for monitoring device safety (http://brodyhooked.blogspot.com/2011/08/medical-device-industry-to-iom-drop.html), one might have thought that the FDA would appreciate the help they were getting to call for more stringent regulations--but instead the FDA went out of its way to defend the current inadequate practices and to blast the IOM's conclusions. Since then, as per previous blog posts referred to above, the device industry has unleashed a lobbying armageddon on Congress, demanding less rather than more regulation of device safety lest a single good job in the US be sent overseas.
The combination of merciless lobbying plus FDA capture makes it highly unlikely that we'll see a day anytime soon when the US public can have much confidence that medical devices are adequately checked for safety. How it works out that there's a huge media outcry if a single person dies from E.coli in their lettuce, but dozens or hundreds can die due to malfunctioning medical devices without anyone losing any sleep, needs to be better explained.
Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ 341:966-68, 6 November 2010.
Lenzer and Brownlee looked in depth at the vagus nerve stimulator manufactured by Cyberonics, a device in which a pacemaker-type pack is surgically inserted near the collarbone, and electrodes are wrapped around the vagus nerve in the neck. The device was intended at first for a select population of patients with a particular type of epilepsy that's resistant to all drug treatment. Like many devices and drugs (and in keeping with the Inverse Benefit Law, http://brodyhooked.blogspot.com/2011/03/synthesis-why-drug-industry-tries-to.html), once having gotten the camel's nose into the tent, Cyberonics is now claiming that the stimulator can be used for a large number of other conditions, notably depression, and perhaps obesity and traumatic brain injury (stay tuned for hair loss and bad breath). All such uses rely on the purported safety of the device, which is what Lenzer and Brownlee zeroed in on.
In 1997, Cyberonics went to the FDA to get initial approval of the stimulator for epilepsy. They presented three studies to document the device's effectiveness and safety. One review panelist noted that 17 of the 1000 subjects who'd had the device implanted had died, and asked what was up with that. The explanation offered by the company and other panelists is that people who have that sort of hard-to-treat epilepsy have a high death rate because periodically those seizures cause cardiac and respiratory arrest. So deaths were due to the disease and not the device.
The FDA bought this explanation but added a caveat--Cyberonics got approval conditionally upon conducting a post-marketing surveillance study to address the concern about possible excess deaths.This, as Lenzer and Browlnee explain, is not an unusual measure--the studies needed to lead to drug or device approval are often, of necessity, too small to detect rare but serious adverse effects, and only after a drug or device is more widely used may such effects become apparent.
But here's where the story gets interesting. Lenzer and Brownlee then went after the data accumulated by the company during this mandated post-marketing study phase. They found several very worrisome things. First, there were at least isolated reports of deaths or near-misses that seemed quite clearly to be due to the device. (One patient who survived was observed to have his heart stop at exactly the intervals at which the stimulator fired, and the heart stoppages ceased with the device was turned off.) When asked how many of these events had occurred, or how often, Cyberonics said they didn't know, because mortality statistics were not one of the planned endpoints in any of its trials. And despite the fact that the FDA had ordered these studies because of concerns about mortality, no one at the FDA seemed the least bit worried about the fact that Cyberonics had set up its studies deliberately to exclude mortality data.
For many years, British sociologist John Abraham has written about regulatory capture--what happens when a government agency that is supposed to regulate an industry ends up becoming so closely tied to industry that it becomes a tool rather than a watchdog. When the Institute of Medicine weighed in on how inadequate the current regulations are for monitoring device safety (http://brodyhooked.blogspot.com/2011/08/medical-device-industry-to-iom-drop.html), one might have thought that the FDA would appreciate the help they were getting to call for more stringent regulations--but instead the FDA went out of its way to defend the current inadequate practices and to blast the IOM's conclusions. Since then, as per previous blog posts referred to above, the device industry has unleashed a lobbying armageddon on Congress, demanding less rather than more regulation of device safety lest a single good job in the US be sent overseas.
The combination of merciless lobbying plus FDA capture makes it highly unlikely that we'll see a day anytime soon when the US public can have much confidence that medical devices are adequately checked for safety. How it works out that there's a huge media outcry if a single person dies from E.coli in their lettuce, but dozens or hundreds can die due to malfunctioning medical devices without anyone losing any sleep, needs to be better explained.
Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ 341:966-68, 6 November 2010.
Sunday, September 2, 2012
Healthy Skepticism in Peril
I'm passing along news from Dr. Peter Mansfield, the Australian physician who's the founder of the Healthy Skepticism group and website that I've had occasion frequently to quote from and commend. Sadly, Dr. Mansfield reports that his own time is increasingly spoken for and the finances of the website are tenuous, and unless there's an infusion of either cash or labor or both, Healthy Skepticism will have to close its virtual doors--which would be great for the pharmaceutical industry, I imagine, and terrible for anyone interested in an evidence-based approach to pharmaceuticals and their marketing.
I urge you to check out their website at http://www.healthyskepticism.org/global/ and see what you can do to help this worthy cause. Thanks very much.
I urge you to check out their website at http://www.healthyskepticism.org/global/ and see what you can do to help this worthy cause. Thanks very much.
Monday, August 27, 2012
You Too Can Be a KOL
As in the previous post, I'm grateful to our friends at Health Care Renewal blog for this pair of items.
I have, more times than I wish to count, mentioned the infamous KOL--the Key Opinion Leader, a.k.a.Shill, the doc who engages in marketing for the drug firm and reaps rewards in the form of speakers fees, consulting contracts, involvement in seeding trials, and the like.
So--how do you get to be a KOL?
The first post in order of appearance is by Franz Wiesbauer on a blog called MedCrunch, which describes itself as, "A new kind of online magazine covering health, medicine, entrepreneurship and technology all centered around new trends and the challenge of being a physician."
In a post dated January 14, 2011, Wiesbauer discussed "Pharma Marketing 101":
http://www.medcrunch.net/pharma-marketing-101-two-things-pharma-needs-from-you/
Wiesbauer first reassures the readre that everything he says is strictly on the up-and-up: "While certain physicians have taken advantage of these unethical matters, many of our peers have skillfully used their liaisons to the pharmaceutical industry for the advancement of their careers in an entirely ethical way, and you can do the same." Nobody here except us highly ethical physicians, boss.
The post then goes on to explain what makes a KOL--first, writing a lot of prescriptions so the company wants you on their side; and second, having influence over your peers. Wiesbauer helpfully concludes, "So, to sum up, pharma can provide you with a platform to increase your network, enhance your visibility and strengthen your personal brand. As a physician, you are THE critical component to pharma’s marketing and sales outlets. Know your value and use your influence wisely. It entirely depends on you if you are the ball or the player in the pharma marketing game."
Funny thing--when I took the physician's oath upon graduating from medical school, I have no recollection of any mention of my "personal brand" as a key aspect of my career in medicine.
Now fast forward to August 21, 2012, and to Dr. Lukas Zinnagl writing on a different blog, KevinMD.com. Dr. Zinnagl, we learn, is co-founder of MedCrunch, and he references the earlier post by Wiesbauer in this entry, which adds a new wrinkle--social media:
http://www.kevinmd.com/blog/2012/08/doctors-key-opinion-leader-social-media.html
The earlier post said that if you want to sell yourself to Pharma as a KOL, you need influence. This new post explains how you can get influence virtually overnight if you're a savvy blogger or Facebooker or Tweeter, or whatever today's new thing is. But don't expect that to last long because whatever niche you now fill in the social media world, expect to be jostled by a horde of other docs tomorrow as they move into your turf. So I guess the lesson is, get it while you can. Or as Dr. Zinnagl summarizes: "If you’re one of the physicians who understand and master Twitter & Co, you’re well on your way to establishing your personal brand. But be aware that this advantage will become smaller and smaller as more and more physicians catch the social media train."
Funny--there's that "personal brand" thing again. I really must have a talk with the curriculum committee here at the med school and ask why we don't have a course or clinical clerkship in personal branding. Sounds much more important than anatomy or neurology. Or ethics or professionalism.
I have, more times than I wish to count, mentioned the infamous KOL--the Key Opinion Leader, a.k.a.Shill, the doc who engages in marketing for the drug firm and reaps rewards in the form of speakers fees, consulting contracts, involvement in seeding trials, and the like.
So--how do you get to be a KOL?
The first post in order of appearance is by Franz Wiesbauer on a blog called MedCrunch, which describes itself as, "A new kind of online magazine covering health, medicine, entrepreneurship and technology all centered around new trends and the challenge of being a physician."
In a post dated January 14, 2011, Wiesbauer discussed "Pharma Marketing 101":
http://www.medcrunch.net/pharma-marketing-101-two-things-pharma-needs-from-you/
Wiesbauer first reassures the readre that everything he says is strictly on the up-and-up: "While certain physicians have taken advantage of these unethical matters, many of our peers have skillfully used their liaisons to the pharmaceutical industry for the advancement of their careers in an entirely ethical way, and you can do the same." Nobody here except us highly ethical physicians, boss.
The post then goes on to explain what makes a KOL--first, writing a lot of prescriptions so the company wants you on their side; and second, having influence over your peers. Wiesbauer helpfully concludes, "So, to sum up, pharma can provide you with a platform to increase your network, enhance your visibility and strengthen your personal brand. As a physician, you are THE critical component to pharma’s marketing and sales outlets. Know your value and use your influence wisely. It entirely depends on you if you are the ball or the player in the pharma marketing game."
Funny thing--when I took the physician's oath upon graduating from medical school, I have no recollection of any mention of my "personal brand" as a key aspect of my career in medicine.
Now fast forward to August 21, 2012, and to Dr. Lukas Zinnagl writing on a different blog, KevinMD.com. Dr. Zinnagl, we learn, is co-founder of MedCrunch, and he references the earlier post by Wiesbauer in this entry, which adds a new wrinkle--social media:
http://www.kevinmd.com/blog/2012/08/doctors-key-opinion-leader-social-media.html
The earlier post said that if you want to sell yourself to Pharma as a KOL, you need influence. This new post explains how you can get influence virtually overnight if you're a savvy blogger or Facebooker or Tweeter, or whatever today's new thing is. But don't expect that to last long because whatever niche you now fill in the social media world, expect to be jostled by a horde of other docs tomorrow as they move into your turf. So I guess the lesson is, get it while you can. Or as Dr. Zinnagl summarizes: "If you’re one of the physicians who understand and master Twitter & Co, you’re well on your way to establishing your personal brand. But be aware that this advantage will become smaller and smaller as more and more physicians catch the social media train."
Funny--there's that "personal brand" thing again. I really must have a talk with the curriculum committee here at the med school and ask why we don't have a course or clinical clerkship in personal branding. Sounds much more important than anatomy or neurology. Or ethics or professionalism.
Pfizer: Make That Criminal Settlement #10
A not atypical scenario-- while I've been napping over here, the people at Health Care Renewal have been posting a number of important items. You might for example want to read about the hospital CEO who's collected $1.5M in severance pay after wrecking his institution and after one of his VPs was sentenced to jail for (among other things) stealing artwork from the hospital. But in this message I will merely call attention to: http://hcrenewal.blogspot.com/2012/08/pfizers-pforeign-pfiasco.html
Pfizer, it seems, recently agreed with DOJ and SEC to pay $60M to settle cases involving accusations of foreign bribery, mostly in Eastern Europe:
http://www.bloomberg.com/news/2012-08-07/pfizer-agrees-to-settle-foreign-bribery-case-with-u-s-.html
More on foreign bribery in a moment. Our esteemed colleague Dr. Roy Poses at HCRenewal walks us through the previous instances in the last decade where Pfizer has paid whopping fines (the top one being $2.3B) to settle cases involving fraud and other criminal matters--making this latest #10 on the list.
Dr. Poses goes on:
Yet the company has not failed or been restructured, and none of its leaders has ever faced any negative consequences. In fact, last year its CEO made over $18 million, up from over $6 million the year before...
So obviously it is not just that one company's culture has become seriously corrupt. We seem to live in such a corrupt nation, and maybe such a corrupt global society that such corrupt cultures thrive in our major corporations and organizations. Despite stories like this in health care, just like in finance despite the global financial collapse, as Charles Ferguson said at the Oscar awards last year, " not a single ... executive has gone to jail, and that's wrong."
Back to foreign bribery-- when I was writing HOOKED, one of the first books I came across in my research was a 1984 volume by an Australian sociologist of business, John Braithwaite, with the telling title, Corporate Crime in the Pharmaceutial Industry. Much of the corporate crime Braithwaite documented was overseas and involved countries where official corruption was rampant and where US corporations figured it was just a cost of doing business to pay bribes to officials. Silly me--I had imagined that since Braithwaite first wrote, laws had tightened up, reforms had occurred, and companies maybe now had a cleaner track record overseas. Silly me.
Pfizer, it seems, recently agreed with DOJ and SEC to pay $60M to settle cases involving accusations of foreign bribery, mostly in Eastern Europe:
http://www.bloomberg.com/news/2012-08-07/pfizer-agrees-to-settle-foreign-bribery-case-with-u-s-.html
More on foreign bribery in a moment. Our esteemed colleague Dr. Roy Poses at HCRenewal walks us through the previous instances in the last decade where Pfizer has paid whopping fines (the top one being $2.3B) to settle cases involving fraud and other criminal matters--making this latest #10 on the list.
Dr. Poses goes on:
Yet the company has not failed or been restructured, and none of its leaders has ever faced any negative consequences. In fact, last year its CEO made over $18 million, up from over $6 million the year before...
So obviously it is not just that one company's culture has become seriously corrupt. We seem to live in such a corrupt nation, and maybe such a corrupt global society that such corrupt cultures thrive in our major corporations and organizations. Despite stories like this in health care, just like in finance despite the global financial collapse, as Charles Ferguson said at the Oscar awards last year, " not a single ... executive has gone to jail, and that's wrong."
Back to foreign bribery-- when I was writing HOOKED, one of the first books I came across in my research was a 1984 volume by an Australian sociologist of business, John Braithwaite, with the telling title, Corporate Crime in the Pharmaceutial Industry. Much of the corporate crime Braithwaite documented was overseas and involved countries where official corruption was rampant and where US corporations figured it was just a cost of doing business to pay bribes to officials. Silly me--I had imagined that since Braithwaite first wrote, laws had tightened up, reforms had occurred, and companies maybe now had a cleaner track record overseas. Silly me.
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