Thursday, December 4, 2014

Marketing, Advertising, and Safeguarding Objectivity

blame (third-person singular simple present blamespresent participle blamingsimple past and past participle blamed)
1.     To censure (someone or something); to criticize.  [quotations ▼]
2.     (obsolete) To bring into disrepute.  [quotations ▼]
3.     (transitive, usually followed by "for") To assert or consider that someone is the cause of something negative; to place blame, to attribute responsibility (for something negative or for doing something negative).


To provide context for this post, I refer any interested readers to the previous post and the comment by Steven Reidbord, MD.  I started typing up a response and decided to just continue it into this post.  I like to post things in regular blog format, because the comment section is uneditable and I make frequent spelling and grammatical errors.  My intent is to provide my perspective rather than disprove any of Dr. Reidbord’s points which are basically critical points about assigning blame, the standard of proof that physicians are affected by marketing and advertising, assertions about the connection between all of the marketing components and the profits of pharmaceutical companies and the need for physicians to “safeguard” their objectivity.

On the issue of blaming Big Pharma, of course they have done all of those things.  I would expect them to because that is typical behavior of corporations.   There are some people that believe this indicates that all corporations are evil.  There is also a blanket level of condemnation of the industry independent of any specific legal charge or incident.  You can certainly find rhetoric against all industrial sectors.  Nobody seems to acknowledge that governments have developed this landscape, including a regulatory landscape that encourages individuals to take risks without worrying about any personal or criminal penalty.  Litigation for large corporations is seen as the cost of doing business.   It seems that if anything, the law is written to incur legal activity and legal fees.  It is probably no accident that most lawmakers are attorneys.   I am no more outraged about Big Pharma corporate behavior than I am about any other industry. 

Before anyone tells me that medical industries are somehow different because they deal with peoples’ lives, if you think about it numerous industries deal with peoples’ lives.  Some are actually toxic to peoples’ lives.  Others  (like medicine) have affiliated professionals with professional responsibilities but unlike physicians those professionals (who also work with industry and receive benefits from the industry) are seldom scapegoated because of it. 

On the issue of marketing, I have made the same arguments that Dr. Reidbord makes to Big Pharma critics for at least a decade.  I am usually met with the response that physicians have a higher calling and that we must somehow place ourselves above advertising so that we are not commercially influenced.  The corollary is all of the “proof” that advertising and marketing influences purchasing and therefore prescribing behavior.  There are many problems with the analogy and that argument.  First, the proof generally refers to a fairly loose body of literature with poorly stated hypotheses and experimental designs that are either nonexistent or inferior to any clinical trial designed by Big Pharma.  I am happy to entertain any evidence for this connection in the event that I have missed something.   Apart from lack of the experimental evidence, it defies common sense.  I am unaware of any multi-billion dollar product-based industry that thrives on advertising an inferior product and not backing it up with anything.  To use the automotive example, if I unwittingly purchase a Toyota based solely on a flashy ad and discover it is a lemon, I may conclude that this is an aberrancy or that all Toyotas are lemons.  Either way they are unlikely to find me as a future customer.   That is not a sustainable business model.  The general assumption about pharmaceuticals is that physicians don’t seem to be able to self-correct by noting deficiencies including a lack of efficacy during hundreds or thousands of prescriptions.  I find that to be much more likely that noting your car is a lemon.  With prescriptions physicians are professionally accountable to purchasers.  That is a higher standard than losing time or money on a car.  Second, if I respond to marketing and go down to my car dealer for a $500 cash rebate, 0% financing, or some other incentive, I will not be placed in some national database that can be used to suggest that I am morally inferior to physicians who are not in that database.  Oh sure,  there will always be the usual disclaimers that being listed in the database is really an appearance of conflict of interest rather than actual conflict of interest, but the implication of wrongdoing is palpable and usually evident by what is being written about this list.  Third, the reality of a general lack of effective medications is never really acknowledged.  I have never seen a study about marketing pharmaceuticals that takes that into account.  It is common in clinical practice even before the advent of DTC advertising to see patients who were desperate to try the next new drug on the market.  In many cases we are still looking for a reliable car in a field of Yugos.  We are not looking for a Corvette.  Does that mean we have been influenced by advertising?  Does that mean that the patient/consumer has been influenced by DTC advertising?  It may simply mean that we are faced with a large number of drugs with a lack of uniform efficacy and significant toxicities.  Fourth, there is an overgeneralization of an imaginary boundary problem between pharmaceutical companies and physicians that seems to flow from the marketing rhetoric.  Suddenly companies are not only marketing drugs, they are selling medical diagnoses and treatment guidelines.  Managed care companies and PBMs get a complete pass on this issue and the idea is that the Big Pharma-Physician alliance is in lock step to sell as many drugs as possible.  That is a rather pathetic characterization of the problem and the pat solution of cutting all industry ties is an equally pathetic pseudosolution.   I do consider the business end of Big Pharma to be marketing and advertising.  I think the effect of that marketing and advertising is a vastly overstated political argument.  I think it is hubris to imagine that physicians can’t self correct in the way that any consumer self corrects when purchasing any advertised product.

With regard to what is necessary – like most criticism of Big Pharma nobody is ever really explicit about their meaning.  Practically all articles written about Big Pharma marketing/advertising tactics especially those that involve physicians imply that everyone in that chain of events is working to enhance the bottom line of the pharmaceutical company.  Working for the monied interest of a pharmaceutical company is the conflict in conflict of interest. If you are asking the question: “Who said this was necessary?” I guess my answer would be; “Just about everybody.”

The last question that I hope to address is the idea of “safeguarding” one’s objectivity.  In the previous response the idea was that the physician psyche is so frail and easily persuaded that we need to avoid all contact with Big Pharma advertising.  If that is the case there are many other sources of discordant special interest information that we should avoid like the plague including less competent attending physicians and colleagues, less dynamic medical school lecturers, all forms of managed care, most hospital and clinic administrators, most media outlets and most federal regulations on billing, coding, and documentation.  Off the top of my head I could add previous standard medical practices like the Swan Ganz catheter,  massive back surgeries for back and neck pain, chronic high dose prednisone for COPD,  and meperidine injections for migraines.  The list is endless.

If my objectivity was that tenuous I would be sitting in a dark room somewhere practicing psychiatry the way it is described in the New York Times.   I would be depending on a blog or pious journal editors to keep me honest!  
   
I have no conflict of interest to declare.  I have rigorously avoided Big Pharma advertising and detailing long before it was fashionable to do so.  My interest in avoiding Big Pharma advertising was that I found it to be disruptive, annoying, and demeaning - largely to the reps seen lugging food up and down hospital and clinic hallways.  I will probably never consider myself too stupid to figure out advertising even at the purported mind-control levels.  If anyone reading this disclosure doubts this statement – feel free to look for my name in the database of corrupted (or not) physicians.
 
As a further point of disclosure, I drive a Toyota.  I have a general policy of driving a car until the 150,000-200,000 mile mark and then buying a new one.   I find that by that time most cars have multiple systems that start to fail and it becomes a long series of expensive repairs and safety problems.   I have been driving Toyotas for 10 years and that follows a long line of Chevrolet, AMC, Plymouth, and Pontiac products.  Irrespective of the advertising, my personal experience is that it is the most reliable and cost effective ride for the money. 

Those are my only interests in both Toyotas and new pharmaceuticals. 

  
George Dawson, MD, DFAPA


Supplementary 1:  Posted definition at the top is from Wiktionary per their open access agreement. I intended to use it here more as a graphic than text as a lead in to the article.  

Supplementary 2:  For anyone considering a post here as a comment - please consider composing your comment in a word processor and cutting and pasting it in here.  The comment section on Blogger is not a reliable area to compose and edit comments.  I have lost several myself and the text may be too small to edit.  If the comment appears to have been posted but it does not appear - please send me an e-mail.  It occasionally gets diverted to a spam folder and I can still retrieve and post. 



    

14 comments:

  1. Thank you for replying to my comment in such detail. We agree that the conduct of Big Pharma is typical of corporations generally (with the possible exception of certain illegal marketing practices). I do not thereby conclude that all corporations are evil. Nor that the medical industry requires a higher standard of conduct than other industries — although it is notable that the U.S. and New Zealand stand alone in allowing direct-to-consumer advertising of prescription drugs. Indeed, the fact that Pharma legitimately shares the marketing practices of other industries is exactly why physicians need our own professional ethics to guide relationships with that industry. Because Pharma does nothing wrong in trying to influence our prescribing practices — we are wrong to welcome it.

    I believe the burden of proof lies with those who argue that Pharma promotion is ineffective. Is this a claim that advertising and personal sales calls are worthless across all industries? Or is it a more specific claim that advertising works in general, just not for physicians? Both of these strike me as extremely unlikely — in your words, they defy common sense — but I'm open to be swayed by evidence.

    Of course, the physician psyche is not especially frail or easily persuaded. And this isn't an argument to publicly shame doctors, nor to "shelter" ourselves from all drug ads. It's about taking reasonable steps to remain unbiased. I'm curious what you make of my analogy with the computer consultant. Is it ok for the consultant to enjoy nice dinners with the attractive Dell rep, and to receive a new laptop ("for educational purposes only") from Apple? Or might clients harbor legitimate concerns that Sony computers will get short shrift?

    To me, avoiding undue commercial influence parallels our usual stance regarding socializing with patients outside the office. It's unethical to actively seek it out or to voluntarily accept an offer. On the other hand, we needn't hide under the bed for fear of running into a patient in everyday life. If it happens, it happens. I'm curious why this distinction as applied to patients is so clear and readily accepted, and yet so obscure and problematic when applied to commercial influence. And yes, this applies as well to the "... many other sources of discordant special interest information that we should avoid." Again, no need to hide under the bed — just don't actively seek it out.

    I commend your longtime avoidance of Pharma advertising and detailing (and of course I believe you). I appreciate the opportunity to provide my perspective in more detail on your blog.

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    1. Thanks - although is retrospect I was probably saved by a combination of taking myself very seriously as a teacher, introversion, misophonia, and a lack of interest in professional football. The sounds of people chewing food during conferences or grand rounds drives me up the wall. In the early 90's when a drug rep approached me and suggested that I might be interested in giving a CME lecture in the luxury boxes during half time at a game I balked. When he said: "You're interested in football aren't you?" That was all I needed to hear to know this was really not about CME.

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  2. The issue is not to "blame" anyone but to look at who is doing what in reality.

    I hate managed care as much as you do but I still recognize that the cost of medicine on a macro level cannot be ignored. Managed care actually did correct some of the ridiculous over-hospitalization problems from the seventies, but then they went on to reduce lengths of stay beyond all reason.

    I have nothing against drug companies per se and think they do a lot of good work, and certainly believe in capitalism as long as it's regulated, but if you don't think they are not disease mongering and paying off academics to influence them to teach residents bullshit about bogus diagnoses like "pediatric bipolar disorder" and "bipolar II," then I suggest you take a look at the behavior and the success of Joseph Biederman and Hagop Akiskal. I was a training director and I had to constantly fight a reductionistic mentality taught to residents during their training.

    You might also look at the so-called "Zyprexa documents" - internal company memos that detailed exactly how Eli Lilly was going to turn behavior problems that should be treated with psychotherapy into "bipolar disorder" in the minds of physicians. I have a copy of some of them in powerpoint if you want to see them. They have succeeded. We have a whole hospital in Memphis where almost every patient with anxiety disorders and borderline personality disorder is ROUTINELY diagnosed as bipolar on the basis of what they did during a rage or panic episode. (Part of that is so they will get reimbursed, but most of the psychiatrists there really believe in their diagnoses). Then there's the push to demonize antidepressants in REAL bipolar depression (see http://davidmallenmd.blogspot.com/2011/08/plausible-deniability.html).

    I believe that the problems in psychiatry today are the result of a whole confluence of interests that have aligned including managed care, pharma, corrupt and ego-driven academics, and a public that wants a pill for every problem and guilty parents who try to assuage their guilt by assuming that their children's behavior problems are caused by a disease and not by their own dysfunctional parenting. Blame is counterproductive, but so is ignoring reality.

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  3. "Blame is counterproductive, but so is ignoring reality...."

    You had me and then you lost me.

    If the issues are as complex as you say they are and I certainly agree - reality does not come down to spinning the choices down to one thing or another, Democrats or Republicans, conservatives versus liberals, etc.

    I think what we need to offer to improve the debate (and flesh out reality) is a look at all of the possibilities. In you pediatric bipolar disorder for example is it possible that the research group made a mistake? I heard directly from Kenneth Towbin, MD of the NIMH Intramural Research Program on how to approach that problem and the results of his very elegant research on pediatric bipolar disorder:

    http://real-psychiatry.blogspot.com/2014/10/university-of-wisconsin-2nd-annual_15.html

    He was also quite aware of the clinical realities of medicating out of control children in the face of absolutely no clinical or social resources. One of his colleagues provides a review of some of the issues in this week's NEJM:

    http://www.nejm.org/doi/full/10.1056/NEJMra1315612

    So I guess we can view this as a Big Pharma marketing exercise or a lack of adequate research. If you are unaware of the adequacy of the research and you are dependent on a marketing department PowerPoint it is easy to see how you might make mistakes. As I have previously posted - all you have to do is know how to make a diagnosis of bipolar disorder and you won't be diagnosing everyone with the problem.

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    1. Biederman was not guilty of "mistakes" in pediatric bipolar disorder.. His earlier work shows that he is well aware of psychosocial issues that he later ignores completely. I've spoken personally with Akiskal, and the same thing in his work on bipolar II. According to the New York Times, Biederman promised the makers of respiridol that his study on pediatric bipolar disorder would come out positively before the study even started! I'm all for giving people the benefit of the doubt, but this stuff is like oil company climate "scientists" finding that the jury is still out on climate change. Like we don't have satellite photos showing the polar ice caps melting or something.

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  4. I've made the analogy before of pharma as id and KOLs as ego/superego as the way things used to work. I don't expect pharma to stop acting the way it does because it has a duty to its shareholders, not to MD blog critics. We can bitch and whine until the end of time, but pharma will always care more about a big shareholder such as the California retirement system than anything we say.

    Therein lies the responsibility of the KOLs, which they have abdicated. These are the same sanctimonious hypocrites I remember from medical school and residency who couldn't stop criticizing private practitioners of being greedy and unethical.

    I say bang without pause on the KOLs, asking pharma to change is like asking sharks not to feed.

    Besides, we need them and the role of hostile dependent needs to be handled delicately. I don't think 2 billion dollars and 15 years to develop a new drug is exactly fair to them or to the sick. What I really fear is more ineffective regulations that will be selectively enforced.

    Streamline, simplify, full transparency. More of what we are doing won't work.

    By the way, I agree with Dr. Allen's gestalt analysis of the problem completely. There is plenty of blame to go around as the public WANTS medicalization for a number of reasons, including avoidance of blame.

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    1. I agree completely with your characterization of corporations in general and how Big Pharma is really not a special case. Any reasonable citizen should be skeptical of any corporation and understand that corporations who want your money are not necessarily your friends and despite any hype to the contrary will probably not do a good job of taking care of you. There are many examples from other industries.

      On the issue of KOLs, I have always though that their influence was overblown. I go to conferences to hear KOLs (I am assuming there can be KOLs that are not sponsored by Big Pharma). Clearly there are personalities involved here and resentments that I am not aware of. I don’t think it makes sense to criticize people for their personal employment contracts or conflict-of-interest arrangements with their employers. I also don’t think it makes sense to attack specific leaders on a selective basis for what is really a widespread issue. I am of course referring to what I see as highly selective attacks on psychiatrists, especially now that we know (at least in the latest iteration of the PPSA database) that orthopedic surgeons, internists, and cardiologists received more payments and psychiatrists did not make the top 5 list of “specialties with the highest values of shares.” Of these specialties psychiatry gets (by far) the greatest “appearance of conflict-of-interest” coverage in the media. I can’t ever recall an internist being maligned for the appearance of conflict of interest. I am sure that some of the fuming bloggers will see my remarks as excuse-making, but I am just looking at the publicly available data and reading the papers.

      As previously stated I believe that blame is not only counterproductive but unnecessary. It detracts from the reality that tens of thousands of psychiatrists go to work every day and they do a good job. They know exactly what they are doing. In spite of all the obstacles they need to put up with from the government, the business world, and the media every day they get results for their patients.

      That is where I got the title for this blog.

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    2. Actually I think the most reprehensible (or at least negligently irresponsible) KOLs have been in 1990s pain management not in psychiatry. This was the genesis of the current opioid prescription epidemic.

      https://www.youtube.com/watch?v=1UArPx7AH28

      The flaws in the Porter and Jick study were obvious but they believed it because they wanted to. Pain patients seeking refills are simply not going to admit to functional impairment.

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    3. The opioid epidemic is one of my professional and teaching interests:

      http://gdpsychtech.blogspot.com/2014/12/opioid-timeline.html

      It has much in common with the first amphetamine epidemic:

      http://gdpsychtech.blogspot.com/2014/09/americas-first-amphetamine-epidemic.html

      They both start out with a bad idea and that idea is essentially a contagion that affects regulation and the public consciousness. Of course anytime addictive drugs are unleashed as a result of a bad idea it is very hard to reign them back in. In this case the death rate from accidental overdose seemed to accelerate after the Joint Commission initiative in the year 2000, but may date it back to the idea that Pain Is the Fifth Vital Sign. It is also very curious that the people who allege that psychiatric drugs are extremely dangerous are curiously silent on an epidemic that kills about 15,000 people a year over the last decade.

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  5. Thanks for the links. I think the pain as fifth vital sign goes to my point about the influence of KOLs and to an even greater extent groupthink medical organizations and the appeal to authority. Not only were the skeptics criticized but dehumanized as painfully out of touch (pun intended) and lacking in empathy. They clearly trailblazed the path of least resistance over a cliff.

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  6. More on Dr. Portenoy:

    http://www.thepoisonreview.com/2012/12/16/the-money-and-influence-behind-pain-as-a-fifth-vital-sign/

    Yes, I think he should be blamed. His major contribution to medicine is a destructive as anyone in the last twenty years.

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  7. What do you do for those in chronic pain then?

    Note that I don't take opiate abuse lightly. My friend's teenage son is currently in his second inpatient rehab for heroin addiction, and heroin pretty much lead to the death of my ex-boyfriend's brother back in the '90's. Not a socioeconomic thing in either case as my friend is solidly middle class and my ex-boyfriend's parents were/are the millionaires next door.

    I remember the oncologist that was at the hospital where I worked being upset by being hounded for writing Rxs for his patients. At the time, I thought he was referring to those with terminal illness but he could have meant any of the people he was treating.

    I also recall a pharmacist telling me that they started medicating for pain in people while they were in medically induced comas because they found out that although the patient couldn't tell you they were in pain, they felt it and remembered it. I don't know how true this is as I've not heard or read about since.

    All I remember thinking at the time was we do more for animals in pain then people. But, now, with opiates abuse spreading like wildfire are people in chronic pain just SOL?

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    1. Here is a good starting point:

      http://real-psychiatry.blogspot.com/2013/02/treatment-of-chronic-pain-with-opioids.html

      One of the problems is that opioids are viewed as the magic bullet. In other words the frequent governing thought is: "If this doctor would just give me enough - my pain would be gone." Chronic non cancer pain is more complicated than that and typically only moderate amounts of pain relief can be expected from opioids. That is generally the level of pain relief to be expected from non-opioid medications. People are shocked to discover that their pain is much better off of opioids and on non-opioid medication combined with physical therapy. In my experience, hematologist-oncologists are generally some of the more skilled physicians in treating the problem.

      On the politics of pain control, ideas about restricted access to opioids in the US doesn't match the data. N. America and the EU has greatest access on a per capita basis to opioids. According to the INCB (2011) the US has 5.2% of the world's population and it consumes 55.4% of the world's morphine and 37.1% of the world's fentanyl. By comparison if we look at the world population without Europe, Canada, Australia/New Zealand and Japan - the remainder of people constitutes 79.7% of the world's population. That 79.7% of the world's population consumes 9.9% of the world's morphine and 19.7% of the world's fentanyl. Even if you consider that many countries in the world have inadequate supplies of very inexpensive opioids, the distribution might give those who think that not enough opioids are being used here somewhat of a pause.

      The Pain And Policy Studies Group (www.painpolicy.wisc.edu) has detailed maps of per capita opioid consumption plotted for every year back to 1964. They plot the INCB data for per capita consumption.

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  8. On that 15K death per year toll, in a Powerpoint I give on the subject I point out that would be about 300 deaths a week, or roughly the same as a Boeing 767 taking off from LAX every week and disappearing into the ocean. I think the public and regulatory reaction would be a little different when you look at it that way.

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