ProPublica Vital Signs

It has been a while since ProPublica came out with a list of physicians who receive money from the pharmaceutical or medical device industry.  They began posting their new list of physicians who get the greatest reimbursement to the outrage of some who saw their Twitter post.  They also posted their updated Vital Signs search engine that allows anyone to search for how much money a physician receives as payments from the pharmaceutical or medical device industry.  I was able to locate my profile (it is not always easy) and it is readable. I do it when they post an update just to make sure there are no errors.  I don't accept money from anybody and also don't attended sponsored free CME courses because that is also listed as a benefit from whoever is sponsoring the course.

Although they are using a practice address I have not had for over 9 years (it is blurred but available on the ProPublica site) - when I was at that site I saw many Medicare and Medicaid patients.  At one point those were the only patients I was treating.  The disclaimers written on this page need clarification.  I am currently working 4 days a week and for me that is at least a 45-50 hour week and seeing full schedules of patients. The reason ProPublica has no information on my medical practice is that I receive no payments from the medical device or pharmaceutical industry, but you don't know that for sure by reading this information and the disclaimers. The introduction to the new database update gives an example of the reporter searching on the names of his primary care MD and the consultants he has seen.  He looks at the report of payments in terms of royalty or licensing fees, promotional speaking, consulting, travel  and lodging reimbursement, and food and beverage reimbursement.  What he does not say is what these figures mean to him.

I have written about this database in the past in terms of what it does and does not mean.  Over the past decade these payments were used as an easy way to discredit physicians, in some cases entire specialties.  Psychiatry and psychiatrists were at the top of the list, despite the fact that according to ProPublica they were ranked well below most other specialties in terms of medical industry payments.  The furor seems to have diminished as physicians are now subject to more rigorous payment reporting than politicians. In modern society - it seems that the illusion of transparency is all that is required to satisfy the moral outrage of the public.  After all - we have politicians who are actively engaged is legislating issues that affect their top campaign contributors.  There could probably not be a more significant conflict of interest and nobody bats an eye.

Despite the unrealistic idea that physicians are easily influenced and are in lock step to treating their patients according to orders from the pharmaceutical and medical device industry - this database serves a symbolic purpose.  That is - personal treatment from your physician will somehow be better now that all of these payments are known. You might make value judgments about physicians on that basis, but it would probably be a mistake. Physicians should be paid for their work and their intellectual property.  As a group they end up giving far too much of it away. And the largest conflict of interest affecting personal medical care is not mentioned in this database.  That is how your insurance company, managed care organization, or pharmaceutical benefit manager rations your care and tells your physician what they must prescribe, what tests to order, and how they can treat you if they want to remain an employee or get reimbursed.  Don't expect to see those numbers anytime soon. And by the way - that rationed care adds at least a trillion dollars to the health care budget - just as a jobs program for administrators and it skims an unknown (but probably large) percentage off the treatment your physician really wants to provide.

In the meantime - remember that this blogger is beholden to no one.

George Dawson, MD, DFAPA



Supplementary 1:

I discussed some critical issues when a Presidential appointee stood to make massive profits while in the Executive Branch.  Although that deal fell through, the President himself has made an estimated $2.3 billion in profits while sitting in the Oval Office.  This is the same President that provided massive tax cuts to businesses and massive rollbacks in environmental regulations on businesses. In the meantime, physicians accepting $10 worth of pharmaceutical or medical device company pizza are reported to the payments database.

Should $10 worth of pizza be a red flag for anything?

Wait A Minute - Is Psychiatry Less Unhinged Than Most Other Specialties?

For the past decade psychiatry has taken far more than its share of hits on conflict of interest from both within and outside of the profession.  There are any number of bloggers that claim their reason for existence is to keep the profession honest.  Needless to say - a smug attitude like that rubs people like me and the majority of my colleagues the wrong way.  But I will go beyond that in terms of conflict of interest and have in many posts on this blog.  Unlike managed care administrators and US Senators, I believe that even physicians are entitled to be paid for the work that they do.  That includes providing CME presentations and doing consulting work - whether or not that includes payment by pharmaceutical companies or medical device manufacturers.  The only reason I do not do that, is to keep my name off the corruption list (implicit) that is currently compiled by an agency of the US government.  That list is episodically analyzed by consumer agencies who think that they are doing somebody a favor by naming any physician who gets reimbursed by industry.  My reasoning is simple - businesses and governments already have a painfully large amount of leverage against physicians -  why provide them with more?  Especially when it involves a good faith effort on your part and somebody is distorting  that effort and doing their best to make it seem like you have done something wrong. More importantly there is the frequent suggestion that a physician is aligned against the interests of their own patients.  I don't think that happens, even if a name is on that list.

This decade long campaign to compile the information has resulted in a difficult to decipher database with many errors.  It takes time to go through the data and sort it out.  It is impossible to try it on a casual basis.  It is a full time job.  The first of these disclosures came out in July of 2015 from ProPublica.   In the article, they looked at the number of days per year that a physician would receive industry payments.  They also looked at the top 20 MDs in each state in terms of payments received and in my home state there were no psychiatrists?  Wait a minute - weren't psychiatrists maligned in the press at the national level by a US Senator and also at state levels as being frequent recipients of pharmaceutical money?  In the most popular post on this blog - I point out that erroneous assumption used by a reporter to criticize the DSM-5 process at the peak of DSM-5 hysteria.  In an attempt to suggest that the DSM-5 may be swayed by the fact that the APA received money from the pharmaceutical industry the author fails to point out that the money received was less than half of what another specialty organization received.  I pointed out in a separate post that the theory that pharmaceutical company money to physicians is tied to pharmaceutical prices is equally flawed.  Taking physicians totally out of the loop results in the most expensive pharmaceuticals in the world in the USA.  That suggests that the monetary influence occurs at the level of Congress and not physicians.

The May 2, 2017 edition of JAMA has a conflict of interest theme.  Many of the articles are editorials with very predictable conclusions.  For the past decade conflict of interest in medicine has been simplified on the one hand in terms of definitions and solutions and politicized on the other.  I abstracted the table at the top of this post from one of the data driven articles (1).  They analyzed data from the CMS National Plan & Provider Enumeration System (NPPES), a database of all allopathic or osteopathic physicians with a national provider number (NPI).  The NPPES records input of all general payments, research payments, and ownership interests of these physicians.  General payments were described as all forms of payments (like speaking fees, food, beverages) other than research payments done under a written protocol.  The ownership interest was presumably in medical concerns but that was not really specified in the article.  The specific listing of specialties is available in the full text of the reference below.  My only focus here is on psychiatry.  I don't think the rankings or specific amounts have any particular meaning.

The abstracted table lists two of the end points in the article -  the percentage of physicians receiving some kind of general payment and the percentage of physicians receiving more that $10,000 per year.  The $10,000 amount was flagged by the the US Department of Health and Human Services as representing "significant conflicts of interest".  In fact, for most physicians who do consulting - it represents about 2 weeks of work.  The news for psychiatry reflected the reality that I am aware of.  Psychiatry was mentioned just twice in the article and both of those mentions were in the above highlighted table.  None of the headlines from the past decade that psychiatrists were getting more money from pharmaceutical companies than anybody else.  A little more than a third of psychiatrists got some kind of general payment with a median value of $171 (median interquartile range of $34 - 442.)  For perspective - I purchase 2 or 3 new textbooks a year that typically range $300-400 apiece.  I also subscribe to the standard online internal medicine text at a cost of $500/year.  I am not saying that the transaction involved textbooks but many do involve educational materials and I am not sure they are not added into this figure.

The second endpoint is the $10,000 figure and psychiatry is lower on this metric with 3.6 % of psychiatrists getting this level of payments.  For context, the upper end of the range for these payments is 11-12% for some specialists and the lower end is at about 1%.   Proceduralists (surgeons and interventionalists like cardiologists) tended to get the highest level of payments usually due to substantial licensing fees and ownership interests in the industry like medical imaging facilities and surgical facilities.

The authors do not draw many conclusions about the data.  They point out that there have been some concerns about accuracy.  In their conclusion section they point to other studies about connections between payments and prescribing patterns that suggest a "subconscious bias" in their decision-making.  In other words, accept a free lunch and start prescribing the medication of the pharmaceutical rep that bought the lunch.  One of the reasons I continue to read these articles is to see if the "subconscious bias" argument has any more evidence to back it up than speculation and rhetoric.  I continue to not see very much.  I have pointed out the flaws in one of their references in a previous post.  In other words there are a number of explanatory factors operating here other than "subconscious bias".  I have not seen any Manchurian candidates among my colleagues.  Physicians use a lot more discretion in prescribing medications than whether or not somebody bought them a piece of pizza.  The easiest way to avoid the brainwashing accusation is to not accept the pizza or payment for an educational presentation.  That is what I and two-thirds of my colleagues do.  When you are squeaky clean according to the US government/CMS, it is easy to develop an unrealistic idea about yourself - as if this hall of shame approach means anything.

The downside of course is that industry and medical education suffers unless there are incentives out there for physicians to do additional work.  If you happen to be a national expert in demand - will you fly back and forth across the country to educate your peers for nothing?  Maybe a time or two but not much beyond that.  If the pharmaceutical or medical device industry needs consultation from an expert - will you go to a multi-billion dollar a year business and provide your expertise for nothing?  There are no academics from any other department in any university that are expected to do that.  Another piece of the equation that is never mentioned is how physicians are reimbursed relative to the pharmaceutical industry.  An asthma specialist can see a patient once or twice a year and during that time prescribe $4,000 to $6,000 worth of inhalers.  That specialist might bill $200-300 for their professional time, but that will be discounted by insurance companies.  An argument can be made that physicians are seriously underpaid for managing expensive products and working for the industry is one way around that.  In other words - if physicians were paid for all of the high volume work that they do - they may be less interested in outside consultation with industry.

There are additional arguments about conflict of interest that nobody seems to talk about.  Physician owned medical facilities are often described as being significant sources of self referral conflict of interest.  But what are the advantages of physician ownership?  Not being managed by non-physicians would seem to be the clear cut advantage.  Would these environments provide higher quality and more professional services?  Would they be more likely to treat physicians fairly and cause less burnout?  Would they be more likely to be able to provide the full spectrum of services that their patients need?  Who has the greater conflict of interest - a physician employee of a managed care company who is paid to ration health care for the company's interest or a physician who owns the business and can provide services based on his or her idea of medical quality?  The evidence that these differences exist is widespread.                      

Finally, how much of this conflict of interest rhetoric focused on physicians is designed to control them and keep them in line?  Although there are always qualifiers about this data including its accuracy, the federal government seems to have upped the ante by their description of the $10,000 marker.  Is this the 21st century equivalent of billing and coding violations from the 1990s?  Those investigations were driven more by politics, convention and rhetoric than any wrongdoing.  I can't think of a better example of that than doing $10,000 worth of consulting work and finding out that your name is now on a list produced by the federal government and some media outlet is implying wrong doing or quid pro quo with pharmaceutical companies.

Those are the facts of the list as I see them.  There has not been much discussion of the article or the theme of this edition.  The data within psychiatry confirms what I have seen and it has never been as shocking to me as it has been typically portrayed either in the media or by groups interested in influencing physicians.

It is not shocking at all.


George Dawson, MD, DFAPA



References:

1:  Tringale KR, Marshall D, Mackey TK, Connor M, Murphy JD, Hattangadi-Gluth JA. Types and Distribution of Payments From Industry to Physicians in 2015. JAMA. 2017 May 2;317(17):1774-1784. doi: 10.1001/jama.2017.3091. PubMed PMID: 28464140.

2:  JAMA May 2, 2017, Vol 317, No. 17, Pages 1707-1812.  This entire issue is about conflict-of-interest and the link is here.


Supplementary 1:

Before sending any inflammatory comments please remember that I don't eat the free lunch or accept industry money from anybody.  Feel free to look that up on any list.

Supplementary 2:

Original form of the table.  I had to convert it to a graphic version at the top of this post.

Per Physician Value of General Payments to Allopathic and Osteopathic Physicians by Specialty in 2015
Percentage of physicians receiving general payments	Percentage of physicians receiving >$10,000
1.	1.
2.	2.
3.	3.
4.	4.
5.	5.
6.	6.
7.	7.
8.	8.
9.	9.
10.	10.
11.	11.
12.	12.
13.	13.
14.	14.
15.	15.
16.	16.
17.	17.
18.  Psychiatry (37.3)	18.
19.	19.
20.	20.
21.	21.  Psychiatry (3.6)
22.	22.
23.	23.
24.	24.
25.	25.
26.	26.

Supplementary 3:

Some additional points of interest from other articles in this supplement:

589,042 of 850,000 active physicians in the US received some type of general payment in 2015 with a mean value of $400 and a median value of $138.

Any physician registered at a sponsored CME event is considered to have received a payment whether they consume provided food or beverages or not.

from:  Steinbrook R. Physicians, Industry Payments for Food and Beverages, and DrugPrescribing. JAMA. 2017 May 2;317(17):1753-1754. doi: 10.1001/jama.2017.2477. PubMed PMID: 28464155.

The threshold for reporting is a $10 transfer to the physician.

"At the same time, most physicians have essentially no meaningful COI."

from:  Lichter AS. Conflict of Interest and the Integrity of the Medical Profession. JAMA. 2017 May 2;317(17):1725-1726. doi: 10.1001/jama.2017.3191. PubMed PMID: 28464163.

          

Free Lunch and Odds Ratios - The Rest Of The Story

JAMA Internal Medicine came out with an article this week that has been heavily covered by most media outlets.  The Wall Street Journal headline was: "Even Cheap Meals Influence Doctor's Drug Prescriptions, Study Suggests".   Time concludes: "Why Doctors and Drug Companies Can't Be Friends".  Even public radio got into the act with "Crestor Prescriptions Rise After Doctors Get Free Meals."  It is pretty clear that in the court of public media that Big Pharma is at it again, bribing doctors into using their drugs and the most expensive drugs at that.  But is that really what the article suggests?

Even a casual reader could hone in on the discussion session of the article and read the following about cross sectional data and disclaimers about causation versus correlation:

"Our data are cross-sectional. The findings reflect an association, and not necessarily causality. Because we linked 5 months of Open Payments data with 1 year of Medicare Part D prescription data, we also could not determine whether high prescription rates for brand-name drugs were preceded, followed, or temporally unrelated to the receipt of industry-sponsored meals.  The policy implications of our findings thus depend on further clarification of the mechanism of the association between the receipt of industry-sponsored meals and physician prescribing behavior..."

Two additional paragraphs of study limitations follow that clearly show that this initial look at this data has significant limitations.

Various blogs and sites have picked up on this paper as well many of the physician sites also seem to favor the narrow interpretation as seen in the press.  In some cases there is a nod to the theoretical issue of causality but a discussion of the result as though it is proof of something.  I can think of a number of competing theories that should be tested instead of the meal equals causality theory but do we even have to go there?  Bear with me on the analysis here.

Looking at the basic design of this study, the authors looked at a database of 533, 919 prescribers in the Medicare Part D database.  252,250 of these prescribers were eliminated for administrative reasons that can be examined in the Supplemental section of this paper.  From there the authors determined which of these physicians wrote 20 more more prescriptions for the four study drugs of interest -  statins, cardioselective beta blockers, ACEI or ARB antihypertensive prescriptions, or SSRI or SNRI antidepressant prescriptions.  Table 2 in the final paper shows the total prescribers and their characteristics in each group.  The total number of physicians receiving financial reimbursement varies from 2-12%.  That reimbursement totaled 63,524 payments totaling $1.4 million - 95% of which was meals and 5% in the form of other promotions.  The meals averaged $12-18.  The authors proceed to show that the sample selected for reimbursement were more likely to prescribe the promoted drug.  They do this by calculating the odds ratio of prescribing versus the non-reimbursed physicians.  They also calculate the odds ratio across a number of variables including the number of day (0 -> 4+) in order to demonstrate a dose response effect of the promotions on prescribing and conclude that industry sponsored meals was associated with an increased rate of prescribing the name brand drug in each class that is being promoted.

The standard response to this study seems to be: "Aha - no news there.  We knew that Big Pharma corrupts physicians and even the slightest gift sways prescribing practices."  I will let the reader pull up the article and read the authors concerns about causality.  I don't think that predictable corruption or an esoteric statistical argument about causality is the most interesting part of this paper.  I think the most interesting part of this paper has apparently been lost on the majority of people reading it.  Let me put it another way.  Would it shock anyone that a small (2-12%) proportion of physicians, carefully selected for whether or not they accept promotions from pharmaceutical companies end up prescribing the promoted drugs more frequently than physicians who don't?  I don't think that it should.

The good news in this article is that 88-98% of the physicians studied apparently do not accept these promotions and by the authors definition do not prescribe the promoted drug at anywhere near the frequency of the studied group.  The majority of physicians do prescribe promoted drugs, even without receiving any incentive from the pharmaceutical company and that should also not come as a shock to anyone.  As a former member of two Pharmacy and Therapeutics (P&T) Committees, I can say unequivocally that all members of a generic class are not equivalent when applied to any population of human beings.  Response and tolerability vary significantly from person to person.  In the case of generic antidepressants - SSRI/SNRI are all commonly used as first line drugs primarily to avoid prior authorization harassment of the prescribing physician.  There are many patients who fail several and many patients who cannot tolerate any of these medications.  In those cases non-generic medications are often the next choices.

Any time I see a statistic like an odds ratio, I tend to interpret it like percentages.  Those numbers seldom stand on their own.  There needs to be some additional data.  In the table below, I show the number of prescribers in each category across all 4 classes of research drugs and the Target Drug used to calculate the odds rations.  It is clear that the vast number of prescribers in each class are in the No Meal (NM) category.  It is also clear that the prescribers in the Meal (M) category prescribe the drug class at a much higher rate than their NM colleagues.  Even if the prescribing rates in the M category are relatively high, it is easy to speculate that the total prescriptions for the target drugs may actually be higher in the NM category despite the odds ratios indicating that the M physicians are more likely to prescribe them.  I sent an e-mail to the corresponding author on this issue and asked for the raw data as rates of target drug prescribing in each group or the raw numbers for all of the target and non-target drug prescriptions in each class.  I will post those results here if I receive them.

Class/ Target Drug	Meal =M No Meal =NM	Average Rx Volume Per Prescriber	Total Prescribers
statin/ rosuvastatin	M	742.2	15,941
	NM	470.1	115,266
beta blocker/ nebivolol	M	410.0	3843
	NM	299.8	122,291
ACEI/ARB/ olmesartan	M	562.7	9483
	NM	394.8	121,860
SSRI/SNRI/ desvenlafaxine	M	437.6	1926
	NM	289.5	121,392

Just looking at total prescriptions in any class the NM physicians prescribe roughly 5 times the total of the 4 general classes of medications as those who are designated as M prescribers.  Pharmaceutical companies are clearly selling these medications without the suggested promotion.    This is a better measure of the impact of pharmaceutical promotions and it illustrates the fact that there are other significant forces at play than a free lunch.

Overall I thought this paper was useful because it provided confirmation of one of my previous observations on pharmaceutical pricing.  In that post I made the statement that even when physicians are taken out of the promotion loop by one force or another, the United States still has by far the most expensive pharmaceuticals.  This paper provides proof that the vast majority of physicians are not getting the free lunch promotions and contrary to most of the headlines don't base their prescribing on an inexpensive meal.  Although we currently do not have a good characterization of what the real difference in target drug prescriptions is between N/NM groups it is safe to say that there is more at play here than an $18-20 meal.

That fact alone suggests causation is more complex than it seems in the papers.



George Dawson, MD, DFAPA


Reference:

1:  DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries. JAMA Intern Med. 2016 Jun 20. doi: 10.1001/jamainternmed.2016.2765. [Epub ahead of print] PubMed PMID: 27322350. (free full text online).

Attribution:

Pizza graphic is from https://commons.wikimedia.org/wiki/File%3APizza_(25).jpg
By Miansari66 (Own work) [CC0], via Wikimedia Commons.

Data On Drug Price Comparisons - And The Myth Of Compromised Physicians

See Attributions For Reference

ND = no data

The response to my last post so far was as predicted by what I said in the post.  It is very difficult for people to get around the idea that they have heard for the past two decades - namely "Damn you Big Pharma!"  Over the past 20 years we have repeatedly heard all of the concerns about physicians essentially being bribed by Big Pharma in the form of speaker's fees, free lunch, various trinkets, ghost written research, and free vacations.  We have seen physicians criticized by a member of Congress for failing to disclose income from sources outside of their academic appointments.   We have seen psychiatrists selected out from other physicians with regard to Big Pharma financing despite the work of a well known non-partisan watchdog showing that they are nowhere near the top of the list in terms of total reimbursement or frequency.  Many people have made a career out of adding various conspiracy theories to the basic Big-Pharma<->physician conspiracy and how it has added unnecessary costs to the health care system, put patients at unnecessary risk,  and compromised professional ethics.   The only major change that I have detected is the elimination of the free lunch at Grand Rounds.  I do so appreciate that.  There was nothing that triggered my misophonia more than the sounds of mastication while I was trying to listen to the lecturer.  Now that all of those evil Big Pharma incentives have been eliminated and the risk of public shaming is in place through at least two databases, it would follow that Big Pharma should be hurting - right?  We should finally be getting reasonable priced pharmaceuticals - right?  Not if the following slide from the Kaiser Family Foundation is to be believed:

See Attribution Section Below For The Full Credit For This Graphic

It seems that the public shaming of physicians and eliminating the various forms of the Big Pharma free lunch have not led to the Utopian state of better pharmaceutical pricing.  The really telling information is in the tables at the top.  This data is widely quoted in a number of sources, but is also readily available from the original source.  The US has the market cornered when it comes to the absolute maximum drug prices.  In some cases other countries are only paying about a quarter as much.  My table also removed the maximum prices in the US that are in some cases much higher than is quoted in this table.   This data illustrates why taking physicians out of the equation has has done nothing.  Of course it will be interesting to look at the data over  time databases and make sure that there is the expected lack of correlation.  This data as well as the data on prescription pricing explodes the myth that physician collusion with Big Pharma had anything to do with pharmaceutical company profits.  For years we have had to tolerate vague rhetoric from Pharmascolds like: "If they (Big Pharma) didn't get a return (on their various trinkets, meals, other incentives) - they wouldn't do it."  There was the associated argument that getting free pens would make you start prescribing the advertised drug like you were a Big Pharma Manchurian candidate.  Neither of those arguments had any traction with me, but then again I had not talked with a pharmaceutical rep in over 20 years.  Compare these arguments with the clinical reality that physicians face every day and that is being harassed by managed care companies if they do not prescribe the least expensive drugs.  Any physician prescribing only the latest antidepressant would spend most of their time on the phone with pharmaceutical benefit managers.  They would not be able to practice.

The third argument was the moral one.  That it was somehow unethical to work for a pharmaceutical company or accept anything from them because it represented a conflict of interest.  Notice I did not use the term appearance of conflict of interest.  That is because the Institute of Medicine has decided for all of us that it is so hard to determine a real conflict of interest from the appearance of conflict of interest - why bother?  Consider it all to be conflict of interest.  To me that always seemed like a variation of the automaton argument - I have accepted pizza or a pen and now I can no longer think for myself - I will just automatically prescribe the suggested drug.  Nobody ever examined the strong reinforcement associated with the idea that:  "I don't eat the free lunch and therefore I am morally superior to you."  That unexamined thought seemed palpable on many blogs and websites where daily outrage about these practices was common.

The fallout from this lack of examination has been significant:

1.  Fewer physicians wanting to work with the industry - medicine is probably the only technical profession that makes this suggestion.  In many professions standards are set by active collaboration with industries.  I don't know how a pharmaceutical company can look for new molecular entities without an eye to problems that clinicians encounter and a solid knowledge of the shortcomings of current therapies.  You can't find that in a lab.

2.  Overgeneralizations about psychiatry based on the predictably negative press - psychiatry takes more of a negative hit on just about anything than the rest of medicine.  The Myth of Compromised Physicians has allowed an absurd level of criticism to be leveled at the field and ignore even basic realities that psychiatry specialty organizations and psychiatrists are hardly the most involved specialists with Big Pharma.  You would not get that impression by reading the popular press or the various antipsychiatry sites in the Internet.

3.  An absurd emphasis on evidence based medicine - as though that could somehow save us from the evils of Big Pharma or ourselves.  There have been endless politically biased analyses to prove that psychiatric treatments do or do not work.  In many cases, the result of the study can be predicted by the author's bias.  In many cases the author's bias is evident even without financial conflict of interest disclosures, all that you have to do is read their previous writing.  Many of these papers are foregone conclusions.  They naturally add nothing to the field because they either lack scholarship or that was not their intent in the first place.  They miss on three standards.  The first involves the intent of regulation of drugs in the United States and the science of pharmaceutical research.  There are no perfect drug trials and the results don't have to be perfect to get approval.  In some cases the results are far from perfect and the drug is approved, even against the vote of the involved scientific committee.  Safety considerations are often clarified in post marketing surveillance.   The second involves the positive experience of clinicians using the drug.  Drugs are often prescribed off label with great success and experienced clinicians have often treated many more patients by themselves than were in the original trial.  They may have better results in the trial largely by their experience using the drug and more comprehensive treatment than is available in drug trials.  There are many reasons why the experience of clinicians using the drug would be expected to be better than the trial, but the trial is considered the gold standard of whether or not a drug "works."  The third involves the safety considerations of the physicians using the drug.  There have been some studies that go back and look at all of the side effects of the drug in clinical trials and try to recalculate risks or side effects and adverse outcomes or to prove the pharmaceutical company or researchers were covering something up - they weren't transparent.  Any clinician who studies the FDA approved package insert for the drug and pays close attention to what their patients tell them, will know much more about the dangers of the drug and its side effects, how to detect and treat them better than any group of people reading research reports.  To think otherwise is folly.  

4.  A serious lack of appreciation of what the real problems are in clinical trials and that is biological heterogeneity.  Any number of polygene determined illnesses will understandably not yield positive and uniform results with great effect sizes in response to a treatment.  I don't care if the illness being studied is depression or asthma or diabetes mellitus.  Why is that shocking or surprising?  Why would it be surprising that some researchers want to break these large heterogeneous groups into small subgroups and see if the treatment response can’t be refined?

5.  A stunning lack of examination of the real problem.  That real problem is quite simply special access to all levels of government on the legislative and regulatory side by industry lobbyists.  Industry in this case includes insurance and managed care companies, and pharmaceutical companies.  Physician professional organizations have no similar access.  Nothing guarantees profits more than lobbyists sitting in a smoke-filled room and writing legislation that regulates your industry.

Take physicians out of the loop and what do you have?

The most expensive prescription drugs (by far) in the world.



George Dawson, MD, DFAPA




Supplementary:

Doctor databases: These databases are there to list payments to physicians from pharmaceutical or medical device manufacturers.  I refer to them as public shaming databases because that is  what they are used for in the press and blogosphere.  There are also obvious comparisons for similar databases that exist for Congress and the obvious fact that transparency doesn't work.  Feel free to look for my name, but I can tell you in advance that you won't find it:

Open Payments - The Official US Government Web site - https://openpaymentsdata.cms.gov/

ProPublica - Dollars For Docs



Attributions:

1:  The Table "2013 Drug Prices In Various Countries" is from a report by the International Federation of Health Plans.  The report is titled: "2013 Comparative Price Report Variation in Medical and Hospital Prices by Country."  It is quoted in many places including the reference below and the report is freely available as a PDF document.  It was accessed on 1/30/2016.

2:  The graphic of "Growth In Prescription Drug Spending......" was downloaded as a Power Point Presentation entitled Attachment-Rx-Spending-and-Use-UPDATED 12.31.2015.  Author is The Henry J. Kaiser Family Foundation. It was accessed on 1/30/2016 and is used by a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License

Marketing, Advertising, and Safeguarding Objectivity

blame (third-person singular simple present blames, present participle blaming, simple 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.