Is Data Mining Protected Commercial Speech?
27 CommentsBy Ed Silverman // June 24th, 2008 // 5:12 pm
That’s a key issue being debated in Vermont, where the state has proposed a law that restricts the sale of prescription drug info that identifies prescribers and patients for commercial marketing purposes. The effort is being challenged by IMS Health, Wolters Kluwer Health and Verispan, with support from PhRMA, which contend the law hurts public access to healthcare info. This is the original lawsuit.
In a brief in support of the state, Sean Flynn, associate director of the Program on Information Justice and Intellectual Property at American University’s Washington College of Law, writes “the commercial speech doctrine serves consumer interests in being fully informed of products and services on the market by providing limited protection to advertisements and other speech to consumers proposing a commercial transaction.”
“Pharmaceutical companies engage in commercial speech when they advertise their products through media and in-person sales calls to doctorss The commercial speech doctrine does not extend protection to use of information by private firms that does not communicate with potential buyers. The plaintiffs are not communicating with potential buyers when they monitor the prescribing practices of physicians, and therefore this practice is not accorded protection under the First Amendment.”
“Indeed, the First Amendment calculus weighs strongly on the other side - of protecting the autonomy right of individuals to decide when to speak and to whom. Vermont’s law provides a mechanism for prescribers to choose whether to share their prescribing information with pharmaceutical marketers and therefore serves rather than limits important First Amendment interests.” (Look here and scroll to the bottom to read the entire brief).
What do you think?
Should the drugmakers have waited to release the SEAS results?
- No (73%, 82 Votes)
- Yes (27%, 31 Votes)
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Dan
By having the prescribing data, the plantiffs are potentially causing prescriptions to occur deceptively.
Just as kickbacks could have a similiar effect on a prescriber.
Dr. Sal Giorgianni
This is an important and thorny issue. The implications of this lawsuit may extend well beyond prescription market data.
I firmly believe that companies have an absolute right to this information. Understanding it has material effect on their intellectual property and business interests. Only in a rather circuitous way would I believe that this has any relevance to commercial free speech and that is without this information product producers could not effectively, safely and efficiently manage their products and thus craft important and relevant communications to customers. That said, I remain a bit hard pressed at this juncture to support the commercial free speech argument. I would like to be persuaded otherwise. Those who support closing the door to companies obtaining legitimate access to this type of data for PhARMA should consider the implications of this on their own businesses.
This is an issue that has been addressed, without satisfactory outcomes, many times in the past. Having been involved in much of the debate in the late 1990’s/early 2000’s a key concern seems to be identifying information of the specific prescribers. Sure, industry would like to keep access to identifiable information, as that makes the work of sales bonuses and territory alignment much easier and it gives sales persons information that just plain old helps them do their job, persuade customers. These are quite legitimate needs of sales organizations and a right inherent in their right to exist. Just as a flesh-and-blood legal person needs air to breath, corporate-entities need legitimate information to flourish. Yet, annomized prescribing data, aligned by zip-code might also provide needed data and provide a useful compromise. This would allow companies to maintain information flow important to their economic survival but address the issue that gnaws at most every prescriber’s heart-strings – being watched, measured and targeted.
You sure picked a controversial one here Ed! The blogs on this could probably extend into next year.
Bob Freeman
I’m going to take the con on this one, Sal. Pharma companies sell to wholesalers, mail order pharmacies and retailers. I believe any intellectual property rights are exhausted at the point of sale, and patient and physician confidentialy overrides any so called free speech rights. If pharma wants to know something about physicians’ and patients’ utilization let them do primary data collection with random sampling techniques. Then phyicians and patients can opt in or out of providing info. I maintain pharmacies should not be providing these data.
Given that pharma and the data collectors will prevail, simply impose user fees (taxes) or supplemental Medicaid rebates at the state’s level.
anonymous
I don’t think (could be wrong) that patient identifiers are purchased with this data. A company only knows what a physician prescribed (assuming it went through retail), not for whom or for what. And ask any rep, even those data are highly suspect.
American want medicine and pharma to be encapsulated in a protective bubble where the grime and infection of money and markets won’t taint them. So let’s make pharma work blind–market blindly, sell blindly, guess at their customers’ behavior and needs. That is sure to produce superior products in the future. And after pharma, let’s do food (look at all those salmonella deaths; some greedy capitalist is profiting somewhere!). The horizons for hypocrisy are endless…
M Helm, MD
Twenty years ago - when I was starting in the industry on the Market Research supplier side - the data in question was not commercially available. Sales targeting was done, not in the corporate headquarters, but by the reps and managers in the field. There were data on sales into zip codes, and from that, market shares could be calculated (as well as sales volume - which is actually the more important measure). Reps spent time calling on pharmacists and physician office staff to gain insight on who prescribed their meds, and their other preferences.
There was no handy listing which showed market share and trends of prescription dispensing linked to a physician. There also weren’t nearly so many reps. Nevertheless, go back and think about the 80s and early 90s. PhRMA profitability and innovation were not lacking. There were in fact many more individual manufacturers “back in the day.”
The data captured at the retail pharmacy level provide much information which goes well beyond the supposed “needs” for commercial free speach. I know that the data include whether the prescription was covered by Medicaid, a private plan, or purchased with cash. Patient age is captured at some point for at least a percentage of the data sampled. Obviously, the physician or clinic is identified, along with the pharmacy. This is a large amount of individually identifiable information. I’m sure that IMS and the other providers of these services have diligent processes in place to protect against capturing patient names, addresses and the like, but is that the point?
It is very difficult to argue that any of this information is truly vital to on-going operations of PhRMA companies. It may allow for more efficient “targeting” of reps. These data can also be used to track the impact of speakers programs and other promotional activities directed specifically at targeted MDs. But there are other ways (as Bob points out) that this information can be obtained.
The Vermont law is not a threat to PhRMA, but it is to IMS, Wolters-Kluwer, and Verispan. However, the threat is only to the extent that other states or the federal government pass similar laws. Fortunately, each of these companies have a number of other products and services which will allow them to continue. It seems hard to make an arguement that there needs to be public access to this type of health information. It is also impossible to argue that limitations on individual prescibing practices would in any way impact new drug development.
I’m not even clear on who actually owns the data (and has the right to sell it). If Medicaid or a private payer covered the costs (or the bulk of the costs) don’t those entities have an ownership right? If you put yourself in the position of a payer, or a Medicaid program, would you want this information handed over to someone who would use it for their own purposes? The way the data are sold, the only groups that seem to be paid are the pharmacies that sell the data, and the authors of the pharmacy software systems.
war horse
There’s a great old saying–your rights start where my rights end. Patients have a right to privacy–this includes their prescriptions. Just because some other group really, really wants that information does not do away with this right.
Jack2
The information is de-identified. Companies don’t get any patient data.
Former pharma Marketing Exec
What is wrong with a company tracking their own sales?
Much like Dr. Helm, in my early days in marketing we didn’t need to “buy” this data. We access information like incidence and prevalence of disease per region and see where are sales are.
This business keeps IMS and other companies alive, but it is at the cost of patients rights. No, I am not worried that patients will be identified, but selling the lists and making up advertising saying that 9 out of 10 doctors prescribe this drug other than another is no way to approach medical decision making - it obscures the facts. Drugs should be sold on the basis of how well they work. The drug that is the right one is the one that works for the patient based ont he individual patients need.
Hope Vermont wins…
Justice in MI
Clarifying question. While pts are not identified, physicians are - right?
Based on internal sales memoranda that have emerged in one context or another, this does not seem mainly used for overall info about how a product is doing. At least in the instances we hear about, it has more to do with further supporting (in a variety of ways) docs who do a lot of writing for the med, assessing KOL or related marketing collaborations with that doc, and “neutralizing” docs who have gone elsewhere or are “collaborating” elsewhere.
As I understand it, the numbers are also used to assess performance of reps, possible promotions, etc..
Is this a misunderstanding of the way the data is used? Does it miss the major issues involved?
Jack2
You are correct JIM. Just to clarify though, I would say the FIRST use of the data is to track overall sales by geography. The SECOND use is for the individual rep to go in forewarned before the next call, to try to tailor the message.
The data can also be used for all the other reasons you outlined.
Justice in MI
Thanks for that clarification, Jack2!
Dr. Sal Giorgianni
Jack2’s summary of data use is fundametally correct. It is also correct that patient information is not now part of the data set. Some years ago PhARMAs entered into agreements with pharmacy service companies, such as CVS and Walgreens and with PBMs such as Caremark to have data sent by them to patients who used their drugs but companies did not get the patient identified data. This was one of those bad practices that helped precipitate HIPAA.
Justice in MI
Actually, I still get monthly letters “from my pharmacist at Rite Aid” which (it says in small print at the bottom) actually come from TAP reminding me that my rx for Prevacid will soon need to be refilled.
In fact, I haven’t used Prevacid for years. So the practice goes on, with HIPAA too.
As it happens, my pharmacist (salt of the earth guy) views it with contempt. A number of elderly patients have gotten confused by the letters and he ends up having to clarify things and let them know the letters didn’t actually come from him.
Daniel Carlat, M.D.
Recently, the New England Journal of Medicine published this interesting Sounding Board article by Aaron S. Kesselheim and Jerry Avorn, both of whom are physicians at Brigham and Women’s Hospital and Harvard Medical School. They are leading proponents of efforts to limit the use of prescription data-mining, and assisted the state of New Hampshire in its ultimately unsuccessful efforts to ban the practice (see this article for some background on various legislative actions).
At issue is whether prescription data-mining and other promotional activities are considered “free speech” and thus protected by the First Amendment. This has been a major argument of the pharmaceutical industry in its ongoing litigation in several states that are considering bans.
The authors distinguish personal speech, which is strongly protected by the First Amendment, from commercial speech. Whereas any limitation on individual free speech requires that the government have a clear interest in limiting a particular person’s speech (a high legal standard that is rarely met), limitations on commercial speech are based on different standards. The main framework used by courts is called the “Central Hudson Test,” after a 1980 case in which a utility company sued New York State over regulation of their advertising.
Based on that case, courts now allow limitations on commercial speech if three conditions are met. First, the government must have a substantial interest in the issue (in the case of prescription data-mining, the government indeed has a substantial interest in the relevant issue, which is public health); second, the proposed regulation must directly advance those interests (banning data-mining reduces the potential for non-scientifically based physician prescribing behavior); and third, the proposed regulation must not be more extensive than necessary to achieve its goals (the New Hampshire courts ruled against the ban partly because it agreed with Pharma arguments that there are less restrictive ways to counteract drug company misinformation, such as programs to better educate doctors about evaluating promotional claims).
I found this a valuable article for understanding some of these issues. Happy reading!
Sean Flynn
It is worth noting also that Phrma and IMS argue in their briefs in this case that prescription data mining is not only commercial speech, but fully protected social/political speech the regulation of which should be (in their view) subjected to the strictest scrutiny under the Constitution. This would mean that governments attempting to regulate in favor of the privacy interests of doctors and patients regarding the use of individual identities in prescription records would have to meet the same legal standards applied to public censorship of newspaper articles or political speeches based on their disfavored content.
-Sean Flynn
Ben Schaefer
I side with Sean on this. I think Pharma has taken the free speech argument way too far, up to the point of perversion. Physicians should always ask themselves if what they do is in the interest of their patients. We have to hold others involved in the health care field to the same standard. I think the sale of prescription data helps a lot of people (Pharma shareholders, IMS employees), but I firmly believe it does zip for patients. In fact, by facilitating marketing of expensive (often second line) drugs, it may harm them, or at least their wallets. Thus even if the commercial speech argument holds up, I think New Hampshire’s interests (in this case the advocates of patients) should trump Pharma’s profits.
Dr. Sal Giorgianni
Anyone, but particularly Dr. Carlat,…
Would you outline your views on just how the public health is adversely affected by tracking deitentified product prescribing data? or Would you outline your views on just how the public health is adversely affected by tracking identifiable prescriber data. And as appropriate please provide references and specific examples of such harm to prove your hypothetical.
Thank You.
You know folks, evidence-based practices should not just apply to biomedical science it should also apply to public policy debates.
Justice in MI
For Dr. Sal - I am not Dr. Carlat, so he will hopefully have more to say.
The evidence I need for my own point is on this thread - your own and others’ agreement that the primary purpose of this data, besides showing overall trends, is to focus marketing efforts on particular docs - rewarding/inducing those who write for the drug often, “neutralizing” those who do not. Additionally, it is used to assess detailers performance.
Targetting “friendly” doctors by further inducement is, by definition, putting marketing over science. Unless you can demonstrate that these communications/inducements themselves involve only the provision of evidence-based studies - and nothing else - I do not believe there is another way to understand it.
So I think the onus would be on those who disagree with that conclusion to show how collecting this data _contributes_ to public health. That is a different issue than whether it is protected speech. But if you want to bring into the discussion the issue of public health, then that also cuts both ways.
Are you aware of any evidence-based studies which demonstrate the contribution of collecting prescriber data to public health?
M Helm, MD
Dr. Giogianni,
The following article contains 93 references used to support the authors contention that conflicts of interest have a material impact on treatment patterns, despite arguments posited to the contrary:
Article: Debunking Myths in Physician-Industry Conflicts of Interest.
Author: Lichter PR
Journal: American journal of ophthalmology
ISSN: 0002-9394 Date of Pub. 06/05/2008
PMID: 18538299
Dr. Lichter concludes that the interests of patients are not placed first as a consequence of these conflicts. A quote from Dr Lichter’s abstract explains the relevance to the challenge you presented: “The sophisticated marketing plan seeks access to physicians through gifting mechanisms to ingratiate them and to influence them to prescribe industry’s drugs and to purchase its products. Despite widely accepted studies that demonstrate that industry’s marketing activities influence physicians’ medical practice behavior to the detriment of patients and the public, physicians persist in voicing myths to justify their partaking of industry’s largesse.”
This is merely the most recently published article in a peer-reviewed publication referenced by PubMed.
Additional sources (and arguments against facilitating physician targeting) can be found at http://www.PharmedOut.org. (Full disclosure, I know and respect Dr. Fugh-Berman who led development of the PharmedOut site.)
The following article argues in favor of access to drug samples:
Article: Medicare beneficiaries and free prescription drug samples: a national survey.
Author: Tjia, Jennifer J
Journal: Journal of general internal medicine : JGIM
ISSN: 0884-8734 Date of Pub. 06/2008
Volume: 23 Issue: 6 Page: 709
PMID: 18365289 DOI: 10.1007/s11606-008-0568-2
However, another recent analysis revealed that patients whose physician’s provided them samples experienced higher medication costs in the subsequent time period when compared to patients who did not receive samples. (Sorry I don’t have that reference handy, but it was widely reported. I think it was also covered here.)
I would argue that neither sample use analysis addressed prescriber or patient adherence to treatment recommendations or assessed health related outcomes, so this is not a complete picture.
I could give you a more specific and particularly egregious example of an inappropriate use of prescriber information. This relates to the launch promotion of an atypical antipsychotic which continued for more than a year. Targeted physicians included pediatricians and child and adolescent psychiatrists. This was despite the fact that the product in question was: 1) new to the market, 2) approved only in adults for two of the most severe mental illness conditions, 3) never studied for effectiveness in treating any condition in children and adolescents, and 4) lacking information establishing metabolism and dosing, and both short and long-term safety in children. I’m certain that you would not accept my sources on this information as credible. They include reports from clinicians and pharmaceutical representatives (both in the company in question and employed by competitiors) so it is difficult for me to prove their veracity to you.
The result was extraordinarily high rates of use of the promoted product in a vulnerable population. The vast majority of this use was paid for by Medicaid and SCHIP programs. The manufacturer has already paid one very large fine for inappropriate marketing activity, but I suspect there may be more civil and criminal prosecutions. If you can accept that this could happen, how can you argue that it is not in the interest of public health to avoid this result?
I absolutely agree with you that public policy should be evidence-based. I would argue that the public health is harmed any time there is inefficient allocation of limited resources. If a medication addressed a significant curable/treatable public health problem, AND the medication is the best possible agent (this in itself requires definition), AND it is used in the most effective manner possible to minimize risks and maximize benefits, this is what I argue is an efficient use of resources. If there is more than one treatment meeting this standard, and one is less expensive, use of the less expensive, but equally effective/valuable treatment would be the more efficient.
Prescribing information is used to target physicians for marketing messages. These messages are delivered with the intent to alter treatment patterns in favor of whomever develops the message. The message and the desired treatment pattern change are not designed to be in the best interest of public health - though admittedly, they may be coincidentally aligned in some cases.
It would be nice to be able to assess the impact of pharmaceutical promotion on efficient allocation of limited health resources. However, in this country (or any other industrialized country), where would you find an appropriate control group? There is no group of healthcare providers or patients who are free from exposure to promotion. How would you propose to develop the evidence base we should use to answer the question you pose?
Truly, I don’t have a problem with a manufacturer desiring to promote their product. I’m neither anti- nor pro-PhRMA. I think our health-care system is badly dysfunctional on many levels, and I think that is the real shame. We would all be better off if there was some way to find common ground to move on to a more efficient system using the strengths and balancing the needs of all “stakeholders.”
I do have a problem with the argument that says “we’ve done things this way for years, so therefore we have a right to continue.” It is not the duty of PhRMA companies to be concerned with efficient allocation of resources. But, a large portion of the resources for health care are derived from local, state and federal taxes. I think the state and federal governments (as well as other payers) have a right to limit uses of data created incident to pharmacy transactions which they pay for.
Dr G, sit back for a bit, and if you’re up to it, I’d like to present you with a challenge. Please share with us all an estimate of the portion of Pfizer revenue coming from Medicare Part D plans; Medicaid and SCHIP plans; DoD and VA covered programs; Federal, State and Local government employee and retiree insurance plans; Federal, State, County and City correctional facilities; State and Local Public Mental Health Systems, Public Health Service programs, etc. I would wager that well over half of Pfizer’s revenues are derived from tax collections.
The “golden rule” of healthcare remains: “he who has the gold makes the rules.” To me, this means the one who pays has the right to the most say. I’m not the one who introduced the concept that “half of all US healthcare spending is wasted,” but given what I’ve seen and done/helped to accomplish over the past few years, I believe the statement to be true. The presence of one PhRMA sales staffer for every 2 or 3 physicians in the country does not lead to a less wasteful healthcare system.
Dr. Sal Giorgianni
Dr. H…the presumption imbedded in your note is that I work for Pfizer. Just to clarify, I did some years ago but I do not now. Prior to working for this company I had been in academia, (Columbia University), and at a hospital in NYC where some of my responsibilities were to run the formulary (including financial management and information management), drug information and drug-use review programs there. After what seemed like a lifetime at Pfizer (and in the 1600’s, before pharmaceuticals) would probably have been), I retired and did consulting for professional associations and am not at another University starting up a new school of pharmacy in a new college of health sciences (I still do some independent consulting but not for any PhARMAs). So I have been privileged to see these perspectives from many angles. I now have the luxury of rolling all of these experiences into opinions that are not encumbered by buy-side or sell-side influences (that is I don’t work for a hospital, a university that buys drugs, or for a company or organization who sells ‘em). Do I have my biases – sure; all I can offer is perspective.
I would like to give some thought to your question and challenge, but I cannot get at the data. I would venture a bottom-line guess though that this revenue is substantial; I would submit that where the revenue comes from is essentially irrelevant to the discussion of the adverse impact of COLLECTING DATA on public health. Please, hold on there and read on. (For those who just want to get to my point go to *)
Now as to the well taken points that companies market their products and that these marketing activities cause Learned Intermediaries to use their products. Heck, who would argue with that. Companies who make aviation equipment sell aviation equipment to airline companies and Learned Intermediaries purchase that equipment on their behalf impacts public safety. Likewise, in other areas, nuclear power, police departments, military law, Learned Intermediaries are given the responsibility to make purchasing decisions for technically complex products that must be used properly in technically complicated areas that impact public health, safety, welfare and security. If I am not mistaken these companies can, and do market-research and they can and do market products and they do spend lots of $$ doing it. (I will leave the comment that PhARMA marketing and sales activities are somehow ultra sophisticated, as grist for another blogger suggested, except to assert - it’s not highly sophisticated, it is a basic promotional response model - but it is applied to a complex market).
Those of us in health care tend to say “our circumstances are different and special and unique”. Compared to the world of paper-goods, paint and lawn fertilizer we are special; our situation has substantial gravitas but not more than in many other professional-industrial relationships. Looking at just those few simplistic examples above should show there are many such complex markets and service areas that have important impact on the public health, safety and welfare. Public policy about one market should, I believe, be somewhat consistent across similar markets.
Ok, that was the wind up, here is the pitch. Despite the fact that companies collect information on how and who uses their products (which happens in many other sectors) and they advertise and market their products drug companies do so to a Learned Intermediary (let’s hold off on the DTC issue, that is another highly relevant matter). Only if the Learned Intermediary is negligent in their responsibilities or is so conflicted in their interests to persuasion that the public would be subjected to either bad products or over use of products (good or bad). Your logic thread is that tracking data is used to market products, marketing (MUST/ALWAYS) leads to inappropriate use of products and/or (MUST/ALWAYS) leads to use of bad products, these uses harm (ALWAYS) public health and therefore collecting data is bad and should be prohibited. Sorry can’t buy that (pardon the pun).
The fundamental obligation of the Learned Intermediary (FDA/Prescribers/Formulary Mangers) is to cut through the hype and make responsible decisions on behalf of the public they serve. That is the safety net. Unfortunately, as I have noted before, there is a lot of intellectual sloth out there in medical and pharmacy practice land.
Another fundamental question imbedded here: Is there any public good to marketing pharmaceuticals? (or other complex products) Yes, it is part of the technology transfer model. Developers of any complex technology know more about it then most anyone else. If they do not disseminate that information it cannot be used properly. How they disseminate that information is the rub. PhARMA companies could directly disseminate the info. to Learned Intermediaries WITHOUT any secondary validation from external experts but the system that has evolved will not allow that. External experts could disseminate tech. transfer information without consulting with the discoverer/developer but that makes no sense (as least not to me). So we have our hybrid system where companies must disseminate the information and the Learned Intermediaries insist on external validation - thus our system of professional-industrial interaction evolved. Messy, but it is not going to change. Though many of us, including me, wish it would.
* All this distills down to the question: of does marketing an important, complex product (don’t just think of pharmaceuticals, folks) that has inherent safety concerns in and of itself lead to harm of the public. If so Boeing should not market to Delta Airlines. The folks who make guns should not market to the Air Force or the LAPD. The company who makes nuclear reactor “stuff” should not market to public utility companies. Drug companies should not market to prescribers. Responsible marketing (including responsible use of data necessary to create responsible marketing) is not injurious to the public health. In fact I am pleased to debate the notion that cutting off information flow (aka marketing) from those who discover/develop and make these types of products to the learned intermediaries who make purchasing and use decisions does harm the public. To cut off this technology-transfer flow would mean that those who use complex products would have to guess at how to use them properly and/or only rely on information sources external to the company.
There is also another important component to the data collection and information dialog to responsible marketing – that is product safety. No company wants their products used improperly and they must have consumer feedback on field experience with the product. They must also know about product defects. If it is an avionics component, a tazer, a cooling system for a nuclear reactor or a heart medication flow of customer experiences back to the discover/developer through marketing channels and yes data collection channels is rather fundamental.
No simple issues here folks if you just look at the drug market model. And then, if you throw in other market models we add a layer of complexity and the issue of even application of public policy across markets.
Whew…. this calls for at least 2 more cups of coffee.
Lori
JIM -
In addition to tracking use of a specific drug, another use of this data is to determine who the top prescribers in a given class, for example, statin prescribers. In this way, pharma companies are able to target their marketing efforts (detailing, sampling, CME) to those physicians who would make the most difference to sales, while bypassing those physicians who write relatively little. Thus it does provide a service in terms of helping to allocate scare resources.
Dr. Helm - Availability of prescriber-level prescription data would not impact inappropriate targeting of prescribers by specialty (e.g. targeting pediatricians for example). This information will always be available to pharma companies.
M Helm, MD
Dr G.
You are correct, I assumed you still had a connection with Pfizer. I did not know that you were in academia now. My thoughts on clarifying the percent of revenue derived from publicly funded sources was to better understand the extent to which PhRMA and other health care industries could be viewed as dependent on transfers of public funds (for lack of a more eloquent description). I believe one could make an arguement that healthcare manufacturers are essentially government subcontractors (with no-bid contracts).
What would be the point of that understanding? PhRMA and government agencies often seem to view each other with antipathy/antagonism. This is a silly and counter-productive perspective. The industry is largely dependent on government money, and the government depends on manufacturers to produce products for the citizenry, and disseminate information about new technology to the Learned Intermediaries (LIs).
PhRMA, BIO, Medical Devices, etc. all operate under highly regulated environments. These regulatory environments create certain burdens to those already in business, but also represent significant barriers to entry for others not already in business. Additionally government provides legal protections which help to ensure that significant investment costs in finding, developing and evaluating effective treatments (which are in fact rare and hard to find)can be recouped. The protections to permit a return on corporate investment also come with protections for end-users. These relate to an expectation of minimal standards of effectiveness, purity, and safety. In this country, government (as a whole/at all levels) is simultaneously a regulator and the major customer.
The point of my question is really to gain insight on the degree of interdependence. I think this is relevant to the discussion. Understanding the degree to which manufacturers and government payors are interrelated, rather than in opposition, changes the types of questions we may wish to ask. Specifically if we better understand the interrelationship, we may ask different questions about the propriety of the existing systems of marketing and roles and responsibilities of all sides (including the LIs). If we don’t understand/acknowledge the roles and interests of the stakeholders, and can’t agree on what are the desirable objectives/outcomes how can we discuss whether or not the status quo is beneficial or harmful?
On the face, the questions you pose seem to be: “why should processes related to marketing of prescription drug products be changed or restricted?” If I understand, you seem to argue that inertia is acceptable/inevitable/preferrable to limitations on information which is primarily used for marketing purposes. In order to justify limits on this information (which has been in wide use only over the past 10-15 years) you have asked for “evidence” of harm. You do not differentiate between “marketing information” relating to prescriber treatment preference and any other market information in any other industry.
If I understand you, your arguement says that this is not actually a relevant topic of concern because the marketing activities are directed to an LI. Those folks should know better what to do, and have an obligation to perform “above the fray.” Yet, you acknowledge the potential for failure of the LI to fulfill their obligation - and I like the way you describe this as intellectual sloth.
HorusCat, our departed or lurking friend, oft complained about MDs who persisted in prescribing the same medications they learned in residency 30 years ago. This is despite avaialability of newer and potentially better tolerated/safer/more effective alternatives. Surely this is one form. The inverse corrolary is exemplified by other prescribers who approach each new medication as if this were a new toy, using them nearly indiscriminantly with limited understanding of (good or bad) effects. These providers, rather than rely on time-tested medications, and personal experience, seem to rely on the most recent promotional message received, or the proximity of a medication sample. I think we would agree that both of these types of providers represent a failure in the technology transfer flow (to borrow your term - which I also like).
Dr. Lichter makes his own arguments about the degree to which, or likelihood that LIs delude themselves regarding their objectivity. Dr. Fugh-Berman makes many of the same points. There are other sources, but this is not my argument.
I agree completely with you that Dr. Lichter’s characterization of the level of sophistication of the marketing efforts directed at physician is, well, overblown. The efforts aren’t particularly fancy, just well-funded.
I’m going to borrow, but edit the logic stream you suggest I’m using to more accurately reflect my position on this. However, my actual point in all of this is quite different - I’ll come to that in a bit.
Learned Intermediaries (LI) prescribers are targeted for promotion with the use of individual prescribing pattern information. These LIs have human characteristics, and may be negligent in their responsibilities to seek objective information, to maintain expertise, to act in the best interest of those who seek their expertise, and/or to balance the interests of the individual, family, community and society in providing appropriate and responsible care. LIs may have unrecognized conflicts of interest. These characteristics LIs MAY RESULT in inefficient use of limited resources, or harm to the public through inappropriate selection of treatment options, including over- or under-use of specific medications. Undesirable outcomes MAY RESULT from marketing activities designed with the intent of increasing use of newer medications or treatment approaches. Additionally, undesirable outcomes MAY RESULT from targeting marketing messages to physicians based on prior patterns of treatment, or response to promotional activities.
Use of prescriber treatment pattern data is used to target LI prescribers to receive marketing information. This marketing information MAY lead to inappropriate/inefficient use of products. Inappropriate use, or use of less efficient treatment choices MAY harm patients, and MAY NOT contribute to desired public health outcomes/goals. Less than optimally efficient use of limited resources ALWAYS limits the ability to provide public health benefits. To the extent that specific prescriber medication treatment patterns MAY contribute to inefficient allocation of resources, this practice is a relevant topic for public policy debate, analysis and action.
However, my original point in all of this was really more straight-forward. Who “owns” this information? The actual transaction is complex which involves (usually) a two purchase desicion-makers (the prescriber, and the person picking up the medication), a user/beneficiary (the one for whom the prescription is made), one or more payors, and a facilitator (the pharmacist). The prescriber and the facilitator may be influenced by other entities or interests. The data are created to facilitate/track payment to the pharmacy for a product dispensed to a patient, but paid for by a third party. It could be argued that the third party payer, or the individual patient is the “owner” of this record - whether or not personal information is redacted at some point.
The pharmacy counter transaction is not the same as an autonomous decision by a consumer to use a credit card to purchase an item, and thus create a record in a database somewhere. Neither is it the same as a choice to use your grocery store loyalty card to obtain a discount on your bread, when you have been explicitly informed that information about your purchases may be used for marketing purposes.
VERY often the third party in the prescription purchase is an intermediary of a local state or federal government program. This means information on a transaction involving taxpayer money is used by third parties to generate individual gain for private entities. This occurs without explicit consent of the governments or payment of any licensing fee to for the use of an (arguably) public asset. To me this seems analogous to a private company placing an oil well (or a coal mine) on government land, and paying no licensing fee or royalty. It seems inappropriate that these data could be sold without consent/approval of the third party payer. Even when there is not a third-party, the cash-paying customer receives no notice that information on the transaction (not including their name) will be sold for marketing purposes. The customer recieves no remuneration or discount, but is an unwitting, and uncompensated agent for the sellers of the pharmacy data (and the rest of the food chain that follows).
This situation is also different from other consumer markets in that the LI (prescriber) is actually the person making the purchase decision. One could argue that the LI has an ownership stake in the record too. Since the LI has the most at stake in terms of being subject to targeting for marketing information, this group might make some argument for a right to privacy. (The only current option offered by the AMA is a cumbersome and incomplete “opt-out” program. This is because of the value the AMA receives from licensing their physician masterfile data to IMS and the others to build the link back to individual prescribers and addresses.)
The assertion of IMS and others of a “right” to these data is very confusing to me. These data are not needed to ensure technology transfer to LI. In fact for many years, apparently most of your industry career, these data were not available and were not used.
The lack of this information caused no injury to PhRMA back in the day. I would argue that if this data stream dried up PhRMA would not be injured now. These data are in fact extraordinarily expensive to purchase. It was never clear to me that there was a good return on the investment here. I know that when I was in PhRMA, we attempted to target specific messages to specific physicians based on some sophisticated modelling of practice patterns. That effort lost much in translation from home-office to territory rep. Some companies may do (or have done) better, but the level of targeting sophistication I’ve seen in more recent years seems to have more to do with “decile” rankings and annual call frequency targets. I still know many in PhRMA sales, so I’ve stayed fairly current on what happens in the field. Sales operations efficiency is an entirely different topic.
I’m not saying that PhRMA marketing should stop. However, I’m also not conceding that current PhRMA marketing practice is appropriate, efficient, or sufficient to impart full understanding of new technologies/treatments. Neither will I concede that the costs of promotion are justified, or produce a satisfactory return on investment in many PhRMA companies. I would argue that the burden of supporting marketing and sales expenditures creates ever higher gross revenue reqirements on new products which may be developed. This may result in potentially beneficial products being shelved because revenue expectations are not deemed adequate to recoup bloated sales and marketing costs.
It seems that you and I look at this problems with two different perspectives. If I understand, your view is more permissive of the data mining/marketing practices as they have evolved, and would seek definitive evidence of harm to public health to justify a law like Vermont’s.
My view is more restrictive. I’m frankly confused about who has a right to the value created in the transaction, and I think caution is warranted regarding the potential for shifting healthcare resources toward less efficient uses. My assumption is that government has an interest in caution regarding risks to public health, and efficient allocation of limited healthcare resources. There is at least the appearance of risks to both as a consequence of targeting marketing efforts by using highly specific and detailed information on individual prescribing patterns. Additionally, if nothing else, government and other third party payers would seem to be entitled to some share of the spoils if it were deemed appropriate and reasonable to sell these data for private gain.
At the end of the day, I’m afraid we (all of us, not just you and I) will make little progress on improving health and supporting innovation until all stakeholders can work together on defining common, mutually beneficial goals. After that, the stakeholders need to use their individual strengths to work in those directions. Somehow this sounds vaguely socialist, but that is not my meaning. I’m thinking more along the lines of the Japanese industrial development policy initiatives from years back.
For the record, I’m supportive of profit and reward for innovation - though I’m also a stickler when it comes to showing proof that your newer is actually better. I also insist on comparisons of meaningful measures against some reasonable, active, comparable treatment. In short, I have higher standards than the FDA which accepts virtually any treatment which can be shown to be better than nothing.
I think we can’t really achieve progress in improving health, healthcare delivery, and the prospects for industry until a few things start to happen. We must begin to view the complex system as whole with all of its interrelationships. We must seek opportunities to recognize common goals and build partnerships between payers, providers and manufacturers to work toward equitable solutions. We must limit the rock-throwing and name calling, and make a real effort to look beyond short-term, and self-interest. We must maintain flexibility, and not fear change. Like it or not Darwin’s Adapt or Die concept applies to corporation and industries.
Thanks for reading my late-night essay - Let me know if I’ve misunderstood/misstated/oversimplified your arguments. Thanks for the exchange, and stimulus to think more deeply on this issue. I fear we may be boring others, but Ed is always a gracious host.
Dr. Sal Giorgianni
Whew… this is a most thoughtful and interesting/introspective commentary.
It deserves like contemplation on my (others) parts. Give me a couple of days and a few conversations back with folks at the “U”. So if you don’t hear back from me right away I am not ignoring your essay.
And, yes, Ed is a gracious host. I am sure he looks at dialog like this and smiles!
Ed Silverman
Hi Dr. Helm and Dr. Sal,
I’ve been enjoying this conversation immensely and find the insights quite interesting. Thanks for mulling this over - I hope you’ve prompted others to give all this some further thought. In any event, you’re welcome.
Enjoy the weekend,
ed
Doc
Go ahead and sell the data, but MDs should get a royalty - after all the prescription is their creation. I wonder what IMS would do if they had to pay for the ‘original work product’ rights?
anonymous
“I do have a problem with the argument that says “we’ve done things this way for years, so therefore we have a right to continue.” It is not the duty of PhRMA companies to be concerned with efficient allocation of resources. But, a large portion of the resources for health care are derived from local, state and federal taxes. I think the state and federal governments (as well as other payers) have a right to limit uses of data created incident to pharmacy transactions which they pay for.”
If it is government information, then under the Freedom of Information Act, everyone, including pharma has a right to it. Can’t have it both ways, folks. If my tax money bought it, I have a right to see it.
Sales and marketing are the life-blood of capitalism. Targeted marketing saves everyone time and money–those “scarce resources” you are going on about. What is it about pharmaceuticals that makes everyone get so sanctimonious? Are any of you producing anything or providing a service? Do you market and sell or do your customers just appear out of thin air? Do you market to every single person on the planet or do you target your efforts? (Or are you all living off someone else’s money?)
Do you suppose that if you deny access to prescriber-specific data pharma will quit marketing? What do you hope to accomplish? More money spent marketing to more doctors for more products because pharma doesn’t know who specializes in what? I agree with Sal, your argument is nonsense. What it boils down to is you feel justified in trying to restrain the market, because somehow “health” is a sacred cow. It’s like the argument-ending chant, “Think of the children!” And “scarce resources,” give me a break. Then let’s restrain the trial lawyers, because frivolous lawsuits cost the economy billions of dollars that could be spent funding social programs. And let’s restrain the auto industry, because they are inducing us to buy carbon-emitting, money-wasting vehicles that consume many more of our scarce resources than do pharmaceuticals.
While we keep pharma from using taxpayer funded Medicaid/Medicare data, let’s quit paying for taxis to ferry people to the ER to beg the docs their for more ativan. And let’s quit paying for EMTs to carry lonely old people to the hospital because they decide at 10 pm that they’d better do something about the cough they’ve had for three weeks. If you are serious about saving our scarce resources (which by the way, aren’t really “ours” at all–it is money taken from individuals by coercion), then start cracking down on the way the consumers are misusing the system. Start telling people they can’t keep grandma-the-vegetable alive for another week just so all the grandchildren can drive in to “say good-bye.”
The best way to control the flow of money is to make people pay for their own healthcare. Make insurance truly “insurance” and watch people decide they’ll take the generic instead of the branded. Make physicians and hospitals compete instead of collude with the third-party payers and watch prices come down. And maybe they won’t keep grandma alive that extra week, either.
Dan
Data provided to pharmaceutical companies allow for three things to occur, all designed to create thier own product:
The data states the entire volume of prescriptions a doctor may prescribe, and if it is quite a bit, count on that doctor to receive various inducements from such a pharmaceutical company.
The data reflects any support that a prescriber my apparetnly have of a companie’s promoted product. If so, they are viewed ‘in the camp’ of a pharmaceutical company, and count on inducements from this company as well.
This same data allows pharmaceutcal companies to pick those doctors who are of no financial benefit to them. As a result, they are often not seen by thier reps, or even sampled for that matter.
As pharmaceutical representatives, you do not have the right to do what you should to, which is be an asset to the medical community. Yet some reps find ways to still help out such doctors via creative accounting.