See Attributions For Reference
ND = no data
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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?
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
I absolutely agree with you that physician collusion is the least of the problems associated with Big Pharma, but that doesn't mean that sometimes it isn't a problem. You can look how many articles are coming out claiming that antidepressants are ineffective - or should at least be avoided in bipolar depression in favor of antipsychotics - which is complete bull. I don't know about where you are, but the number of psychiatrists here in Memphis diagnosing everything that moves as bipolar disorder and prescribing Latuda for the "depressive" episodes is frightening. (Of course, we were home to Hagop Akiskal for a long time).
ReplyDeleteAll of the patients I have seen for the past 5 years have a primary diagnosis of a substance use disorder. The majority of bipolar, ADHD, and depression diagnoses are due to the substance use disorder, but I have a much different information set that the original diagnostician. I have talked with many thoughtful clinicians along the way who have taken their time in trying to figure it out. They were all psychiatrists.
DeleteYou're lucky that you know a lot of good psychiatrists - I do as well. However, the ones I'm talking about may see a patient who is literally high on cocaine for ten minutes and diagnose them as manic. One of them used a "spending spree" as the main symptom of bipolar disorder in one patient that came to me- the patient had just purchased a bunch of cocaine!
DeleteI wouldn't call it a myth, but an overemphasis. It is true that some of these conflicted KOLs need to be called out.
DeleteHowever on the list of things wrong with pharma, I agree that it's about number 14 on the list.
Number one is the time and cost from research to commercial product. It's too long and too expensive. HIV fast track was a blueprint for how to do it right but for some reason we don't do that.
Number two is the idiocy of CMS not bargaining on price. That chart says it all. There is simply no excuse for this.
Number three is the nonspecificity and invalidity of DSM. Until you define terms more precisely, psych research is garbage in garbage out.
I have zero problem with direct to consumer ads. It's as close as a patient will ever get to hearing a full consent in the age of the 15 minute medication check.
Number 14 on most lists is approaching urban legend territory.
DeleteThe interesting part for me is that after you have rad all of the weak circumstantial evidence for the hypothesis, the average physician just sat back uncomfortable and took that abuse. I realize that my complete lack of communication with Big Pharma reps for 20 years makes me an outlier, but I had first hand knowledge of what was being prescribed and it reflected the prior authorization rules of managed care companies.
Seems like nobody is interested in calling them out for rationing and in some cases unsafe practices.
Yes, the cost of drugs being based on the amounts spent "buying off physicians" is a red herring. The drug companies charge the amounts they do because they can.
ReplyDeleteAlso, "The majority of bipolar, ADHD, and depression diagnoses are due to the substance use disorder..." is something I thought worked the other way around. Ultimately it doesn't surprise me though and it really speaks to the need to finally address our drug abuse culture.
They charge what they can and that number in terms of cash just got a lot bigger with high deductible insurance. Now they know there is a captive $1500 - $6000 just sitting there that the managed care company really does not care about. That is a much better deal for them and the managed care company than going through all of those "cost savings" motions. What better way to drive up prices than with an inflated pool of cash just sitting there for the asking?
DeleteThere are many pathways to a psychiatric diagnosis. I think that you are possibly referring to the self-medication hypothesis. That works for brief periods of time until you build up a tolerance and realize that you need to use to just function at some level. Bipolar symptoms can occur with both chronic use and acute binge use and vary according to substance used.
If the myth of physicians corrupted by Big Pharma is a red herring - why am I the only guy who has seen it? It was the sole focus of many blogs including one that was keeping the entire profession honest. Nothing like using a red herring to keep the profession honest.
"...why am I the only guy who has seen it?"
ReplyDeleteI take that as a rhetorical question but I will answer it anyway. My opinion is that they don't know the nature of business. As such, businesses will continue to run rings around them. Your high deductible hypothesis bears that out.