A bit of breaking news on a topic we have not looked at for some time, courtesy the Prescription Project.
Two bills, from Vermont and New Hampshire, that would restrict medical information companies from using physicians' prescription data and selling the data to drug companies to assist with marketing (as when the drug rep goes into the doc's office knowing exactly how many prescriptions the doc has written for the company's drug and all competitor drugs), have been essentially on hold as the court system decided what to do about them. The U.S. Supreme Court has now refused to review the New Hampshire law; and a New York federal court has refused to issue an injunction against the Vermont law, which goes into effect tomorrow.
The laws basically hold that physicians' prescription data are confidential and you cannot sell them without the physicians' permission. The rulings are a defeat for the pharmaceutical industry which relies heavily on these data sources--not to mention the commercial outfits that sell the data for megabucks. Prescription Project offers a fact sheet on the data mining issue at: http://www.prescriptionproject.org/solutions/rrf?id=0001.
Tuesday, June 30, 2009
Will Psychiatry's DSM-V Be a Huge Growth Opportunity for Pharma?
Today's hat tip goes to our psychiatry ally Danny Carlat, aided and abetted by Doug Bremner:
http://carlatpsychiatry.blogspot.com/2009/06/psychiatrys-dsm-v-process-now-bar-room.html
Carlat, Bremner and colleagues have for some time been deeply suspicious of the process being used by the American Psychiatric Association (APA) in coming up with the current revision of its Diagnostic and Statistical Manual (DSM-V). DSM is huge--it essentially controls psychiatric diagnosis, which in turn controls insurance payments for psychiatric care. The charge from some quarters is that the process has been unduly secretive and that voices critical of some of the measures being considered are excluded.
This is the sort of in-house tiff that non-psychiatrists could be forgiven for yawning at, and who's to say who's right in this sort of back-and-forth, right? Well, Dr. Carlat tells us that the tiff has now degenerated into a brawl, and that the implications are huge for the role of the pharmaceutical industry in mental health.
The trigger for this latest round of pleasantry is an editorial in press at the Psychiatric Times by Dr. Allen Frances: http://www.beforeyoutakethatpill.com/2009/6/Frances_DSM-5.pdf. Dr. Frances was the head of the APA task force that produced the last revision of the manual, which you'll be astounded to learn is called DSM-IV. (Actually there is also a DSM-IV-R but let's not go there.) He offers a thoughtful, well-reasoned and well-documented critique of DSM-V to date. His main criticism is that the DSM-V people have been not at all shy in proclaiming that their edition will revolutionize psychiatric diagnosis, preparing the world for a sea change between the fourth and fifth editions. Dr. Frances asks: And this sea change in diagnosis will be based on exactly what new scientific discoveries? Exactly what have we learned about the nature, causes, and treatment of psychiatric disorders in the last decade that merits turning the old diagnostic categories on their heads? Well, actually, hardly anything at all.
I happen to agree with Dr. Frances that psychiatry has been afflicted with this dearth of new knowledge, which in part explains why recent generations of psychiatric drugs end up looking much worse than they were touted to be when first introduced, as we have documented ad nauseam in this blog. But of special concern to us is how Dr. Frances characterizes the unintended consequences of the announced directions DSM-V is taking. Here are some key passages from his editorial. First, he mentions that even careful preliminary field studies often underestimate how small changes in diagnostic criteria can have a huge impact on the numbers of cases diagnosed: "Thus are false 'epidemics' created.... This issue becomes especially poignant when one considers the great and skillful pressure that is likely to be applied by the pharmaceutical industry after the publication of DSM-5. It has to be assumed that they will attempt to identify every change that could conceivably lead to a marketing advantage--often in ways that will not have occurred to the DSM-5 Task Force. In order to promote drug sales, the companies may well sponsor expensive 'education' campaigns focusing on the diagnostic changes that most enhance the rate of diagnosis for those disorders that will lead to the increased writing of prescriptions."
Dr. Frances goes on: "Undoubtedly, the most reckless suggestion for DSM-V is that it include many new categories to capture the milder subthreshold versions of the existing more severe official disorders. The beneficial intended purpose is to reduce the frequency of false negative missed cases, thus improving early case finding and promoting preventive treatments. Unfortunately, however, the DSM-V Task Force has failed to adequately consider the potentially disastrous unintended consequence that DSM-V may flood the world with new false positives. ... The result would be a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatments--a bonanza for the pharmaceutical industry but at a huge cost to the new false positive 'patients' caught in the excessively wide DSM-V net."
Well, Dr. Frances' criticisms of the Task Force did not sit well in the halls of the APA, and so before the editorial was even published, an APA rebuttal was sent out over the signature of the President, the chair of the Task Force, and other worthies (http://www.scribd.com/doc/16953085/PsychTimesFrancesResponse-062909-FINAL). The rebuttal basically denies the truth of most of what Dr. Frances says, especially about the secretive and closed nature of the DSM-V process. (More on that a bit later.) But what seems quite rich, and prompted Dr. Carlat's "brawl" description, was the way that the APA leaders tore into Dr. Frances's reputation. Dr. Frances, as the above quotes indicate, leaned over backwards to avoid impugning the motives of the Task Force; he spoke over and over of "unintended" consequences, and did not accuse anyone in the Task Force of actually having conflicts of interest with the pharmaceutical industry. In reply, the APA leaders directly accused Dr. Frances of writing his editorial due to his own financial conflict--they claimed that he was about to lose income as the author of a guidebook to the old DSM-IV, and so that was what prompted both the content and the timing of his criticisms.
As Carlat points out, this is such obvious balderdash that it is astounding that anyone in organized medicine could imagine for one minute that this charge would win them any debating points. Like, it was only one day a week ago or so that Dr. Frances woke up and suddenly said, "Omigosh, I'm about to lose all my royalty income because once they publish DSM-V, no one will want to buy my guide to DSM-IV any more"? Like the psychiatric community has not known for years that DSM-V was coming? Plus book authors like me well know how close royalty income on even highly successful books approaches the sums that paid consultants to the drug industry routinely take home.
And just who is making this accusation of financial conflicts of interest against Dr. Frances? Lead author is the APA President, Dr. Alan F. Schatzberg. Does that name ring a bell? How about our previous posting, http://brodyhooked.blogspot.com/2008/08/how-conflicts-of-interest-poison.html? And it's this pot that is calling the kettle black?
I promised one additional comment about the secrecy issue. It turns out that one way that the DSM-V Task Force has imposed secrecy, according to the critics, is by getting members to sign nondisclosure statements. The APA rejoinder is that, "'Confidentiality Agreements' Frances and his colleagues cite as evidence of secrecy around DSM-V Task Force are in reality legal documents designed to protect intellectual property. Attorneys for the APA worked with the DSM-V Task Force and Work Groups to develop these agreements to protect the work product of these volunteers." Dr. Frances reports that at no time during the creation of DSM-IV was it found necessary to resort to such "confidentiality agreements."
My question is a simple one. When I read a statement like the above passage from the APA leaders, I would not be at all surprised if I were reading a document produced by private industry, worried about protecting its property and its profits above all else. I would, however, be a bit surprised to see the same language emanating from a professional society whose purported aim is public health and service. Am I the only one who thinks the line between these two types of enterprises has become way too blurred?
http://carlatpsychiatry.blogspot.com/2009/06/psychiatrys-dsm-v-process-now-bar-room.html
Carlat, Bremner and colleagues have for some time been deeply suspicious of the process being used by the American Psychiatric Association (APA) in coming up with the current revision of its Diagnostic and Statistical Manual (DSM-V). DSM is huge--it essentially controls psychiatric diagnosis, which in turn controls insurance payments for psychiatric care. The charge from some quarters is that the process has been unduly secretive and that voices critical of some of the measures being considered are excluded.
This is the sort of in-house tiff that non-psychiatrists could be forgiven for yawning at, and who's to say who's right in this sort of back-and-forth, right? Well, Dr. Carlat tells us that the tiff has now degenerated into a brawl, and that the implications are huge for the role of the pharmaceutical industry in mental health.
The trigger for this latest round of pleasantry is an editorial in press at the Psychiatric Times by Dr. Allen Frances: http://www.beforeyoutakethatpill.com/2009/6/Frances_DSM-5.pdf. Dr. Frances was the head of the APA task force that produced the last revision of the manual, which you'll be astounded to learn is called DSM-IV. (Actually there is also a DSM-IV-R but let's not go there.) He offers a thoughtful, well-reasoned and well-documented critique of DSM-V to date. His main criticism is that the DSM-V people have been not at all shy in proclaiming that their edition will revolutionize psychiatric diagnosis, preparing the world for a sea change between the fourth and fifth editions. Dr. Frances asks: And this sea change in diagnosis will be based on exactly what new scientific discoveries? Exactly what have we learned about the nature, causes, and treatment of psychiatric disorders in the last decade that merits turning the old diagnostic categories on their heads? Well, actually, hardly anything at all.
I happen to agree with Dr. Frances that psychiatry has been afflicted with this dearth of new knowledge, which in part explains why recent generations of psychiatric drugs end up looking much worse than they were touted to be when first introduced, as we have documented ad nauseam in this blog. But of special concern to us is how Dr. Frances characterizes the unintended consequences of the announced directions DSM-V is taking. Here are some key passages from his editorial. First, he mentions that even careful preliminary field studies often underestimate how small changes in diagnostic criteria can have a huge impact on the numbers of cases diagnosed: "Thus are false 'epidemics' created.... This issue becomes especially poignant when one considers the great and skillful pressure that is likely to be applied by the pharmaceutical industry after the publication of DSM-5. It has to be assumed that they will attempt to identify every change that could conceivably lead to a marketing advantage--often in ways that will not have occurred to the DSM-5 Task Force. In order to promote drug sales, the companies may well sponsor expensive 'education' campaigns focusing on the diagnostic changes that most enhance the rate of diagnosis for those disorders that will lead to the increased writing of prescriptions."
Dr. Frances goes on: "Undoubtedly, the most reckless suggestion for DSM-V is that it include many new categories to capture the milder subthreshold versions of the existing more severe official disorders. The beneficial intended purpose is to reduce the frequency of false negative missed cases, thus improving early case finding and promoting preventive treatments. Unfortunately, however, the DSM-V Task Force has failed to adequately consider the potentially disastrous unintended consequence that DSM-V may flood the world with new false positives. ... The result would be a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatments--a bonanza for the pharmaceutical industry but at a huge cost to the new false positive 'patients' caught in the excessively wide DSM-V net."
Well, Dr. Frances' criticisms of the Task Force did not sit well in the halls of the APA, and so before the editorial was even published, an APA rebuttal was sent out over the signature of the President, the chair of the Task Force, and other worthies (http://www.scribd.com/doc/16953085/PsychTimesFrancesResponse-062909-FINAL). The rebuttal basically denies the truth of most of what Dr. Frances says, especially about the secretive and closed nature of the DSM-V process. (More on that a bit later.) But what seems quite rich, and prompted Dr. Carlat's "brawl" description, was the way that the APA leaders tore into Dr. Frances's reputation. Dr. Frances, as the above quotes indicate, leaned over backwards to avoid impugning the motives of the Task Force; he spoke over and over of "unintended" consequences, and did not accuse anyone in the Task Force of actually having conflicts of interest with the pharmaceutical industry. In reply, the APA leaders directly accused Dr. Frances of writing his editorial due to his own financial conflict--they claimed that he was about to lose income as the author of a guidebook to the old DSM-IV, and so that was what prompted both the content and the timing of his criticisms.
As Carlat points out, this is such obvious balderdash that it is astounding that anyone in organized medicine could imagine for one minute that this charge would win them any debating points. Like, it was only one day a week ago or so that Dr. Frances woke up and suddenly said, "Omigosh, I'm about to lose all my royalty income because once they publish DSM-V, no one will want to buy my guide to DSM-IV any more"? Like the psychiatric community has not known for years that DSM-V was coming? Plus book authors like me well know how close royalty income on even highly successful books approaches the sums that paid consultants to the drug industry routinely take home.
And just who is making this accusation of financial conflicts of interest against Dr. Frances? Lead author is the APA President, Dr. Alan F. Schatzberg. Does that name ring a bell? How about our previous posting, http://brodyhooked.blogspot.com/2008/08/how-conflicts-of-interest-poison.html? And it's this pot that is calling the kettle black?
I promised one additional comment about the secrecy issue. It turns out that one way that the DSM-V Task Force has imposed secrecy, according to the critics, is by getting members to sign nondisclosure statements. The APA rejoinder is that, "'Confidentiality Agreements' Frances and his colleagues cite as evidence of secrecy around DSM-V Task Force are in reality legal documents designed to protect intellectual property. Attorneys for the APA worked with the DSM-V Task Force and Work Groups to develop these agreements to protect the work product of these volunteers." Dr. Frances reports that at no time during the creation of DSM-IV was it found necessary to resort to such "confidentiality agreements."
My question is a simple one. When I read a statement like the above passage from the APA leaders, I would not be at all surprised if I were reading a document produced by private industry, worried about protecting its property and its profits above all else. I would, however, be a bit surprised to see the same language emanating from a professional society whose purported aim is public health and service. Am I the only one who thinks the line between these two types of enterprises has become way too blurred?
Monday, June 29, 2009
Eyedrops Make You Blind? Not Our Problem
Many thanks to our colleague Roy Poses over at the Health Care Renewel blog for this news tidbit:
http://hcrenewal.blogspot.com/2009/06/original-excuse.html
Here's the short version:
Here is the kicker. When asked why they had not sent reports of the complaints to the FDA as required by law, the company replied that as they had never claimed that the eye solution protected users against Acanthamoeba infection, they were under no legal obligation to report these complaints.
To which I offer two responses.
I'm not a lawyer but I play one on TV. (Actually I don't.) If I did, my lawyer-character would offer the opinion that U.S. law requires that drugs be both safe and effective. The law requiring that they be safe actually dates back to the original FDA act of 1906, while the requirement that they be effective only goes back to the 1962 amendments passed post-thalidomide. What you claim on the drug's label has a lot to do with the question of whether a drug is effective (for the indication claimed). It has nothing to do with whether a drug is safe. By contrast, a company's legal duty to report complaints of adverse reactions to the FDA is part of the FDA's duty to monitor a drug's safety. So to compare labeling with a duty to report adverse reactions is to compare apples and oranges.
My next response is more important. The Korean branch of a major drug company recent got a sort of skunk cabbage award within the business community when its CEO replied to a group of AIDS activists complaining about the high cost that made one of its HIV drugs unaffordable, that the drug company was not is business to save lives but to make money. This is something that most companies believe, and act like, but not something that most companies say. With Advanced Medical Optics, we now have another example of a firm that is so twisted in its thinking and behavior that it will say flat out that it has no business whatever assuring that people who put its solution into their eyes do not go blind as a result--so long as the money rolls in. Those who still believe that our salvation lies in the unfettered free market please raise your hands.
http://hcrenewal.blogspot.com/2009/06/original-excuse.html
Here's the short version:
- Advanced Medical Optics, later acquired by Abbott, made a contact lens solution.
- The solution was pulled in 2007 after a CDC investigation linked it to cases of a rare, serious eye infection, Acanthamoeba keratitis, resulting in at least 70 claimed cases of blindness or permanent vision damage.
- The company had at least 9 complaints, that it failed to report to the FDA, during the year prior to the solution's removal from the market. When FDA inspectors showed up at the plant to investigate the product recall in June, 2007, they then discovered the complaint letters.
Here is the kicker. When asked why they had not sent reports of the complaints to the FDA as required by law, the company replied that as they had never claimed that the eye solution protected users against Acanthamoeba infection, they were under no legal obligation to report these complaints.
To which I offer two responses.
I'm not a lawyer but I play one on TV. (Actually I don't.) If I did, my lawyer-character would offer the opinion that U.S. law requires that drugs be both safe and effective. The law requiring that they be safe actually dates back to the original FDA act of 1906, while the requirement that they be effective only goes back to the 1962 amendments passed post-thalidomide. What you claim on the drug's label has a lot to do with the question of whether a drug is effective (for the indication claimed). It has nothing to do with whether a drug is safe. By contrast, a company's legal duty to report complaints of adverse reactions to the FDA is part of the FDA's duty to monitor a drug's safety. So to compare labeling with a duty to report adverse reactions is to compare apples and oranges.
My next response is more important. The Korean branch of a major drug company recent got a sort of skunk cabbage award within the business community when its CEO replied to a group of AIDS activists complaining about the high cost that made one of its HIV drugs unaffordable, that the drug company was not is business to save lives but to make money. This is something that most companies believe, and act like, but not something that most companies say. With Advanced Medical Optics, we now have another example of a firm that is so twisted in its thinking and behavior that it will say flat out that it has no business whatever assuring that people who put its solution into their eyes do not go blind as a result--so long as the money rolls in. Those who still believe that our salvation lies in the unfettered free market please raise your hands.
Thursday, June 25, 2009
Why We Cannot Trust the Health Insurance Industry--Deja Vu?
This post requires apologies because yes, this blog remains steadfastly about medicine and the pharmaceutical industry, and I am doing my best not to turn it into a political rant on sundry topics, or a health reform commentary. Nonetheless something I read today resonated so strongly with previous comments here and in HOOKED regarding some of the misdeeds of the drug industry that I could not resist mention.
The Columbia Journalism Review, as part of its health reform coverage, offers an interview by Trudy Lieberman with former and now recovered health insurance executive Wendell Potter:
http://www.cjr.org/campaign_desk/excluded_voices_6.php
I can give you the flavor of the interview if I repeat Potter's statement about how he came to decide it was time to abandon his industry post:
"A couple of years ago I was in Tennessee and saw an ad for a health expedition in the nearby town of Wise, Virginia. Out of curiosity I went and was overwhelmed by what I saw. Hundreds of people were standing in line to get free medical care in animal stalls. Some had camped out the night before in the rain. It was like being in a different country. It moved me to tears. Shortly afterward I was flying in a corporate jet and realized someone’s insurance premiums were paying for me to fly that way. I knew it wasn’t long before I had to leave the industry. It was like my road to Damascus."
If that is not a powerful statement about the state of American health vcare--a scene that Michael Moore would have given a lot to include in Sicko--I'd like to know what is.
Potter is not a great fan of the insurance industry. He recounts the strategies that the industry used in 1993-4 to kill Clinton health reform, and how they are positioning themselves in 2009 once again to kill any reform that does not send huge profits in their direction. Highlights:
I wish everyone in the US would read Lieberman's interview with Potter, in my role as a member of Physicians for a National Health Program. There is really only one conclusion a smart reader can come to after reading that interview--these people cannot be trusted. Any attempt at health reform that allows these folks at the table is a sham. The single payer advocates, who say that we must get rid of private insurance and basically start over, are right, however politically inconvenient their message may be. The politicians who have said that single-payer is off the table, period, from the start are in fact doing the bidding of the health insurance industry, and are would-be reformers in name only.
The Columbia Journalism Review, as part of its health reform coverage, offers an interview by Trudy Lieberman with former and now recovered health insurance executive Wendell Potter:
http://www.cjr.org/campaign_desk/excluded_voices_6.php
I can give you the flavor of the interview if I repeat Potter's statement about how he came to decide it was time to abandon his industry post:
"A couple of years ago I was in Tennessee and saw an ad for a health expedition in the nearby town of Wise, Virginia. Out of curiosity I went and was overwhelmed by what I saw. Hundreds of people were standing in line to get free medical care in animal stalls. Some had camped out the night before in the rain. It was like being in a different country. It moved me to tears. Shortly afterward I was flying in a corporate jet and realized someone’s insurance premiums were paying for me to fly that way. I knew it wasn’t long before I had to leave the industry. It was like my road to Damascus."
If that is not a powerful statement about the state of American health vcare--a scene that Michael Moore would have given a lot to include in Sicko--I'd like to know what is.
Potter is not a great fan of the insurance industry. He recounts the strategies that the industry used in 1993-4 to kill Clinton health reform, and how they are positioning themselves in 2009 once again to kill any reform that does not send huge profits in their direction. Highlights:
- These companies are for-profit firms and are slaves of Wall Street. Anything that would actually enhance health care for the U.S public is of no interest to their shareholders. Anything that would increase profits is--even if it means denying care to the sick. That's the top, bottom, and middle line.
- Insurers will out out a PR blitz as to how socially conscious and pro-reform they are. They will then set up a shadow campaign, run by middlemen posing mostly as grassroots organizations that have no ties to the industry, designed to kill any real reform. What they say publicly and what they are trying to do behind the scenes will be two different things.
- We saw the insurers recently in their true colors when they went before Congress and refused to rule out cancelling a person's policy if the individual develops serious and costly illnesses. If they can go over that policy with a fine tooth comb and find a single thing that person failed to fill out correctly when she applied for insurance, then the policy will be cancelled and that person will be without coverage henceforth (since any new policy would be prohibitively costly). It makes no difference if the single thing that was accidentally left out is irrelevant to the later illness; any excuse to cut costs will be ruthlessly taken advantage of.
- When a bill is finally under consideration in Congressional committees, then we can expect the insurance lobby to go even deeper underground, and even the "grassroots" PR will not reveal the true negotiations that are going on behind closed doors. The industry has lobbying muscle on both sides of the aisle, enough, they hope, to insure that any bill unfriendly to insurance interests will die a quiet death out of public sight.
I wish everyone in the US would read Lieberman's interview with Potter, in my role as a member of Physicians for a National Health Program. There is really only one conclusion a smart reader can come to after reading that interview--these people cannot be trusted. Any attempt at health reform that allows these folks at the table is a sham. The single payer advocates, who say that we must get rid of private insurance and basically start over, are right, however politically inconvenient their message may be. The politicians who have said that single-payer is off the table, period, from the start are in fact doing the bidding of the health insurance industry, and are would-be reformers in name only.
Tuesday, June 23, 2009
Hard Sell--the Movie? Oy Vey
Thanks also to our friends at Healthy Skepticism for this news flash from Hollywood:
http://industry.bnet.com/pharma/10002582/jake-gyllenhaal-anne-hathaway-to-star-in-movie-about-pfizer-sales-rep/
Short version: a pair of stars has signed on to do a move based on the book Hard Sell by Jamie Reedy, former Pfizer drug rep, describing his experiences marketing Viagra.
When I was writing HOOKED, I did cite Reedy's book, in large part because it offered a very rare look behind the scenes at the drug rep's workaday world. I tried, however, to rely on it as little as possible because Reedy made it clear from the get-go that he was an atypical drug rep. I assume that the average drug rep is a hard-working individual who wants to succeed at her chosen career--however unfortunate, in my view, the impact of that career is on the medical profession (which should stand up for its own ethical values, and not blame the drug reps it if has trouble doing so). Reedy, by contrast, made his goals quite clear in the early pages of his book--he wanted to get as much money from his employer in exchange for doing the least possible amount of work.
Maybe Reedy was creating a literary persona to make his story more fun to ready, but bottom line was that he seemed to be such an all-around sleazeball that I could not be sure whether to believe anything he wrote--hence my decision to quote only those few aspects of his book that seemed to rely only on solid facts.
From Pfizer's standpoint, the bad news is that they are making a movie based on this guy's book (the guy whom Pfizer fired as soon as they found out about the book). The good news is that from the fluff piece about the movie, the film will have virtually nothing at all to do with the book. I personally recommend not seeing it, even though the photo provided of the prospective female lead is quite fetching.
http://industry.bnet.com/pharma/10002582/jake-gyllenhaal-anne-hathaway-to-star-in-movie-about-pfizer-sales-rep/
Short version: a pair of stars has signed on to do a move based on the book Hard Sell by Jamie Reedy, former Pfizer drug rep, describing his experiences marketing Viagra.
When I was writing HOOKED, I did cite Reedy's book, in large part because it offered a very rare look behind the scenes at the drug rep's workaday world. I tried, however, to rely on it as little as possible because Reedy made it clear from the get-go that he was an atypical drug rep. I assume that the average drug rep is a hard-working individual who wants to succeed at her chosen career--however unfortunate, in my view, the impact of that career is on the medical profession (which should stand up for its own ethical values, and not blame the drug reps it if has trouble doing so). Reedy, by contrast, made his goals quite clear in the early pages of his book--he wanted to get as much money from his employer in exchange for doing the least possible amount of work.
Maybe Reedy was creating a literary persona to make his story more fun to ready, but bottom line was that he seemed to be such an all-around sleazeball that I could not be sure whether to believe anything he wrote--hence my decision to quote only those few aspects of his book that seemed to rely only on solid facts.
From Pfizer's standpoint, the bad news is that they are making a movie based on this guy's book (the guy whom Pfizer fired as soon as they found out about the book). The good news is that from the fluff piece about the movie, the film will have virtually nothing at all to do with the book. I personally recommend not seeing it, even though the photo provided of the prospective female lead is quite fetching.
More on Tax Deductions for Drug Ad Costs
When I previously blogged about this topic (http://brodyhooked.blogspot.com/2009/06/drug-industry-deducts-advertising-costs.html), I admitted to being fuzzy on a couple of key points. Thanks to our friends at Healthy Skepticism, I now have before me an article by Rich Thomaselli at Advertising Age that offers a little more background (emphasis on "a little"):
http://adage.com/article?article_id=137372
One question was: Given that drug firms in the US spend around $4B annually on direct-to-consumer ads, where does Rep. Rangel get the idea that he can come up with $37B in tax savings, to help finance health reform, by ending this deduction? My own guess was that these are 10 year projections, the usual coin of the realm in discussing health reform, and that assumes that the industry gets to deduct nearly the entire cost of ads. Thomaselli's take:
"There seems to be some issue as to where the $37 billion tax figure comes from, considering the pharmaceutical industry spent $4.7 billion on DTC advertising last year. It is likely Mr. Rangel is referring to total sales costs, costs for sales representatives, free samples and more."
The next question--exactly where did this tax deduction come from in the first place? Us pharmaskeptics were prepared to learn that somehow Congress had been lobbied into passing a special tax exemption for the drug industry only--though I had to admit being ignorant, myself, of any such action. Thomaselli fills us in:
"Dick O'Brien, exec-VP-director of government regulations for the 4A's, said advertising for any product is fully tax deductible as a necessary business expense. Mr. Rangel's proposal would eliminate the tax deduction for one product category, prescription medications, in effect making it more difficult and more expensive to advertise than another category."
So if that account is true, then it appears that Rep. Rangel is not proposing to repeal a special tax deduction enjoyed by the drug industry alone, but rather to exclude the drug industry from a general business deduction now enjoyed by all manufacturers. If so then the road toward enacting this plan would seem to be much steeper, especially given the fact that the media, who enjoy the advertising fees paid by the drug companies for those ads, are now squawking loudly about this proposed taxation.
http://adage.com/article?article_id=137372
One question was: Given that drug firms in the US spend around $4B annually on direct-to-consumer ads, where does Rep. Rangel get the idea that he can come up with $37B in tax savings, to help finance health reform, by ending this deduction? My own guess was that these are 10 year projections, the usual coin of the realm in discussing health reform, and that assumes that the industry gets to deduct nearly the entire cost of ads. Thomaselli's take:
"There seems to be some issue as to where the $37 billion tax figure comes from, considering the pharmaceutical industry spent $4.7 billion on DTC advertising last year. It is likely Mr. Rangel is referring to total sales costs, costs for sales representatives, free samples and more."
The next question--exactly where did this tax deduction come from in the first place? Us pharmaskeptics were prepared to learn that somehow Congress had been lobbied into passing a special tax exemption for the drug industry only--though I had to admit being ignorant, myself, of any such action. Thomaselli fills us in:
"Dick O'Brien, exec-VP-director of government regulations for the 4A's, said advertising for any product is fully tax deductible as a necessary business expense. Mr. Rangel's proposal would eliminate the tax deduction for one product category, prescription medications, in effect making it more difficult and more expensive to advertise than another category."
So if that account is true, then it appears that Rep. Rangel is not proposing to repeal a special tax deduction enjoyed by the drug industry alone, but rather to exclude the drug industry from a general business deduction now enjoyed by all manufacturers. If so then the road toward enacting this plan would seem to be much steeper, especially given the fact that the media, who enjoy the advertising fees paid by the drug companies for those ads, are now squawking loudly about this proposed taxation.
Thursday, June 18, 2009
Case Study: Detecting Marketing Bias in Sponsored Research
I would suppose that a newcomer to this debate over Pharma influence, who does not routinely read medical journal articles, would have the following reaction to many of the arguments put forth in previous posts:
Why are you making such a big deal about industry sponsorship of research? It must be fairly easy to read a medical journal article, assess the methods employed, and decide that a study is of good or poor quality--that one can or cannot trust the findings. Isn't that the key variable--that one can or cannot trust the findings--rather than whether or not the study was sponsored by a drug company?
For this reason I feel justified in placing on record a case study, showing just how far one often needs to "drill down" to discover the evidence of bias in a commercially sponsored research publication. For this example I must thank my friends Rick Bukata and Jerry Hoffman and their excellent audio service, "Primary Care Medical Abstracts."
For their May, 2009 issue, Rick and Jerry discussed a paper by Ho et al. in Lancet (a top tier journal, which would lead some to imagine immediately that no possible skullduggery could have made it past the distinguished editors of this journal). The basic idea here is that Merck (who funded the study and whose role is clearly labeled in the paper) has an investigational drug for migraine headache that is in a new class, calcitonin gene-regulated peptide receptor antagonists. Merck obviously hopes that this new medicine, when approved, will quickly become the preferred therapy for migraine in place of the older standbys, the triptan drugs, which are currently going off patent and becoming cheaper.
The study was set up to compare two doses of the new drug, called telcagepant (we assume Merck will think of a melodious brand name instead of this nearly-unpronounceable generic name), the older standard drug, zolmitriptan at maximum recommended dose, and placebo. They looked at a variety of migraine symptoms at both 2 and 24 hours after the initial drug dose.
How did the drugs compare? Here's how the authors of the paper reported their outcomes in the abstract (the only part of the paper that many busy clinicians ever read): "Telcagepant 300 mg is effective as an acute treatment for migraine with efficacy comparable to that of zolmitriptan 5 mg, but with fewer associated adverse effects." In other words the new drug is clearly better than the old drug.
The abstract prepared by the Primary Care Medical Abstracts team expressed the same data but with a more cautious spin: "In this study, a 300mg dose of...telcagepant was not more effective that zolmitriptan for the treatment of acute migraine."
But to get the full story we needed to wait till Jerry Hoffman had his say on the audio disk. Jerry pointed out a feature of the study design that was not mentioned in the abstract at all, and that was only discussed in the methods section and in Figure 1. The study design called for the option for any subject to receive a second dose of medication at 2 hours past the initial dose, if needed. This feature makes sense because migraine headaches often rebound within the first 24 hours or are not completely relieved by the first medication dose, or both. If the subject was assigned to the placebo group or the zolmitriptan group, the second dose would be placebo. If the subject was assigned to either of the telcagepant groups, the second dose was randomized, half the subjects getting a second dose of telcagepant, the other half getting placebo.
Now, stop and think. Can you imagine any legitimate scientific question that would be answered by having the study design as described? I cannot imagine one. I have to conclude that this study design must have been selected purely for its marketing impact, and not as a way of doing science.
So you can see that the playing field was not level--as Jerry pointed out. A single dose of zolmitriptan was being compared to the possibility of repeated doses of telcagepant. (In actual fact, about half of all the subjects required a second dose, so a total of a quarter of the telcagepant subjects got a second dose of an "active" drug instead of placebo.)
This understanding of the true study design puts quite a different spin on the reported outcomes. What if half the zolmitriptan subjects, who needed a second dose, had been given a second dose of zolmitriptan? Would telcagepant still have been "as effective as" zolmitriptan--or would the older standby drug, and the soon to be the probably much cheaper drug, have proven superior?
You can pretty much answer this question for yourself by studying the finer details of Table 3. Efficacy for each study endpoint was expressed as a percentage of subjects who achieved the target outcome. In almost every single category, at 2 hours, the percentages reaching target were higher for zolmitriptan than for either dose of telcagepant, with the single exception for phonophobia (being bothered by loud noises). In photophobia (being bothered by bright light), the higher dose of telcagepant was slightly better than zolmitriptan (51% vs. 50%). For example, a secondary endpoint, "total migraine freedom [at] 2 hr" was achieved by 22.9 % of the higher-dose telcagepant group, and by 27.2% of the zolmitriptan group. The only endpoints for which there was any superiority for telcagepant were those endpoints that looked at sustained effects over 24 hours--where, as we saw, the playing field was not level and a quarter of the subjects in the telcagepant groups got an extra medicine dose. Even there, the differences were nothing to write home about--for "2-24 h sustained pain freedom," 20.2% of the higher dose telcagepant group, vs. 18.2% in the zolmitriptan group.
Exactly how did the methods section of the paper explain the strange methods, by which one active medication group got a second dose that was denied to the other? Here's what Ho et al say: "The efficacy of the optional second dose is not discussed here since the sample sizes were limited. A prespecified meta-analysis across all of the telcagepant phase III studies is planned to address the therapeutic effect of the second dose." Pardon my cynicism but I interpret this statement as: "We won't report the role of the second dose in skewing the study findings now, because then the reader might actually put two and two together. Instead we'll report them (if we ever get around to it at all) separately at a later time, when we hope you'll have forgotten about the issue, and when we can put a favorable spin on whatever we find one way or another." As I have demonstrated, even without an explicit report from the authors, the raw data in the tables, which the average reader would never bother to look at, hint very strongly that the optional dose at 2 hours skewed the results in favor of telcagepant--and without that skew, the expensive new drug would in all probability not have performed as well as the older and cheaper drug.
I know I put you to sleep a long time ago. My take home message is very simple--this is often how carefully you have to read a published article in a medical journal to be sure you have detected any bias that apparently was introduced by commercial sponsorship. And that, in turn, is why commercial bias and conflict of interest is such a plague on scientific medicine.
Ho TW, Ferrari MD, Dodick DW, et al. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomized, placebo-controlled, parallel-treatment trial. Lancet 372:2115, Dec 20/27, 2008.
Why are you making such a big deal about industry sponsorship of research? It must be fairly easy to read a medical journal article, assess the methods employed, and decide that a study is of good or poor quality--that one can or cannot trust the findings. Isn't that the key variable--that one can or cannot trust the findings--rather than whether or not the study was sponsored by a drug company?
For this reason I feel justified in placing on record a case study, showing just how far one often needs to "drill down" to discover the evidence of bias in a commercially sponsored research publication. For this example I must thank my friends Rick Bukata and Jerry Hoffman and their excellent audio service, "Primary Care Medical Abstracts."
For their May, 2009 issue, Rick and Jerry discussed a paper by Ho et al. in Lancet (a top tier journal, which would lead some to imagine immediately that no possible skullduggery could have made it past the distinguished editors of this journal). The basic idea here is that Merck (who funded the study and whose role is clearly labeled in the paper) has an investigational drug for migraine headache that is in a new class, calcitonin gene-regulated peptide receptor antagonists. Merck obviously hopes that this new medicine, when approved, will quickly become the preferred therapy for migraine in place of the older standbys, the triptan drugs, which are currently going off patent and becoming cheaper.
The study was set up to compare two doses of the new drug, called telcagepant (we assume Merck will think of a melodious brand name instead of this nearly-unpronounceable generic name), the older standard drug, zolmitriptan at maximum recommended dose, and placebo. They looked at a variety of migraine symptoms at both 2 and 24 hours after the initial drug dose.
How did the drugs compare? Here's how the authors of the paper reported their outcomes in the abstract (the only part of the paper that many busy clinicians ever read): "Telcagepant 300 mg is effective as an acute treatment for migraine with efficacy comparable to that of zolmitriptan 5 mg, but with fewer associated adverse effects." In other words the new drug is clearly better than the old drug.
The abstract prepared by the Primary Care Medical Abstracts team expressed the same data but with a more cautious spin: "In this study, a 300mg dose of...telcagepant was not more effective that zolmitriptan for the treatment of acute migraine."
But to get the full story we needed to wait till Jerry Hoffman had his say on the audio disk. Jerry pointed out a feature of the study design that was not mentioned in the abstract at all, and that was only discussed in the methods section and in Figure 1. The study design called for the option for any subject to receive a second dose of medication at 2 hours past the initial dose, if needed. This feature makes sense because migraine headaches often rebound within the first 24 hours or are not completely relieved by the first medication dose, or both. If the subject was assigned to the placebo group or the zolmitriptan group, the second dose would be placebo. If the subject was assigned to either of the telcagepant groups, the second dose was randomized, half the subjects getting a second dose of telcagepant, the other half getting placebo.
Now, stop and think. Can you imagine any legitimate scientific question that would be answered by having the study design as described? I cannot imagine one. I have to conclude that this study design must have been selected purely for its marketing impact, and not as a way of doing science.
So you can see that the playing field was not level--as Jerry pointed out. A single dose of zolmitriptan was being compared to the possibility of repeated doses of telcagepant. (In actual fact, about half of all the subjects required a second dose, so a total of a quarter of the telcagepant subjects got a second dose of an "active" drug instead of placebo.)
This understanding of the true study design puts quite a different spin on the reported outcomes. What if half the zolmitriptan subjects, who needed a second dose, had been given a second dose of zolmitriptan? Would telcagepant still have been "as effective as" zolmitriptan--or would the older standby drug, and the soon to be the probably much cheaper drug, have proven superior?
You can pretty much answer this question for yourself by studying the finer details of Table 3. Efficacy for each study endpoint was expressed as a percentage of subjects who achieved the target outcome. In almost every single category, at 2 hours, the percentages reaching target were higher for zolmitriptan than for either dose of telcagepant, with the single exception for phonophobia (being bothered by loud noises). In photophobia (being bothered by bright light), the higher dose of telcagepant was slightly better than zolmitriptan (51% vs. 50%). For example, a secondary endpoint, "total migraine freedom [at] 2 hr" was achieved by 22.9 % of the higher-dose telcagepant group, and by 27.2% of the zolmitriptan group. The only endpoints for which there was any superiority for telcagepant were those endpoints that looked at sustained effects over 24 hours--where, as we saw, the playing field was not level and a quarter of the subjects in the telcagepant groups got an extra medicine dose. Even there, the differences were nothing to write home about--for "2-24 h sustained pain freedom," 20.2% of the higher dose telcagepant group, vs. 18.2% in the zolmitriptan group.
Exactly how did the methods section of the paper explain the strange methods, by which one active medication group got a second dose that was denied to the other? Here's what Ho et al say: "The efficacy of the optional second dose is not discussed here since the sample sizes were limited. A prespecified meta-analysis across all of the telcagepant phase III studies is planned to address the therapeutic effect of the second dose." Pardon my cynicism but I interpret this statement as: "We won't report the role of the second dose in skewing the study findings now, because then the reader might actually put two and two together. Instead we'll report them (if we ever get around to it at all) separately at a later time, when we hope you'll have forgotten about the issue, and when we can put a favorable spin on whatever we find one way or another." As I have demonstrated, even without an explicit report from the authors, the raw data in the tables, which the average reader would never bother to look at, hint very strongly that the optional dose at 2 hours skewed the results in favor of telcagepant--and without that skew, the expensive new drug would in all probability not have performed as well as the older and cheaper drug.
I know I put you to sleep a long time ago. My take home message is very simple--this is often how carefully you have to read a published article in a medical journal to be sure you have detected any bias that apparently was introduced by commercial sponsorship. And that, in turn, is why commercial bias and conflict of interest is such a plague on scientific medicine.
Ho TW, Ferrari MD, Dodick DW, et al. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomized, placebo-controlled, parallel-treatment trial. Lancet 372:2115, Dec 20/27, 2008.
Subscribe to:
Posts (Atom)
