The True Big Pharma Backers Show Themselves

 

Here is a hint – they are not psychiatrists or even physicians.  They are Republicans.  That may come as a shock to those of you who have absorbed all of the pharma conflict of interest stories about physicians over the past 20 years. Psychiatry in general was selected for much of that criticism. The average physician in the US had no significant conflict of interest even when trivial compensation like meals during continuing medical education (CME) courses were tallied. Some members of Congress even went so far to investigate some psychiatrist’s personal employment arrangements to point out any potential conflicts of interest when it came to pharmaceutical manufacturers.

Today we finally have some clarification on who really backs Big Pharma and wants to assure their large profits.  It should come as no surprise that it is Congress – specifically members of the pro-business GOP.  For years, Congressional conflict-of-interest has been sanitized by their disclosures as if that somehow prevented them from passing pro-Pharma legislation and regulations. For the record the amount of lobby money to the major parties varies from year to year.  For 2022 a total of $26,297,445 was donated from the pharmaceutical industry with $15,175,518 to the Democrats and $10,994,723 to the Republicans. That is an average donation of $29,159 to $105,910.  By contrast the Open Payments site recording payments to health care professionals claims that drug and medical device companies gave physicians $12.59 billion in 2022, but they are counting funds used to pay for research as well as profits from ownership of patents and medical devices (a total of $8.87 billion).  Looking at general payments alone, the physicians receiving any type of reimbursement averaged about $441. The current reporting rule is that any amount exceeding $10 or an aggregate of $100 in the case of meals must be reported.

I previously asked the question whether a slice of pizza given to a doctor at grand rounds was more likely to get results for the pharmaceutical industry than the average donation to Congress ($46,579 at the time).  I made the point that despite the continuous criticism of psychiatrists, they happen to be way down on the list of physicians getting these donations with about 37% receiving general payments and 3.6% receiving payments totaling more than $10,000.

But all the corruption by trivial payments discussion was based on shaky research. It is quite easy to demonstrate that physicians want to try new drugs as they come into the marketplace and show that marketing efforts correlate with prescriptions. We had a No Free Lunch movement to prevent corruption by pizza slices. We had a great deal of agitation about ghost writers, pharmaceutical companies not publishing negative studies, faulty research, side effect reporting, etc. Almost all of that involved psychiatry and often several self-appointed critics from the field.  There are undoubtedly problems with clinical trials in all specialties, but during that 20-year span from about 1998-2018 it seemed as if there was an active conspiracy to sell psychiatric medications.  To some extent that continues but it has less legitimacy in the field particularly since drug detailing and sales have been eliminated from most clinics and hospitals.

All of that commotion was probably good cover for Congress who was actually receiving payments that could make a difference.  And during that time pharmaceutical companies recorded record profits.

What is different now?  The Biden administration has decided that it wants to negotiate prices for Medicare Part D prescriptions. They are on solid ground. The Veterans Administration (VA) negotiates drug prices and has 399 drugs on their formulary.  A GAO study showed that they paid 54% less per unit than Medicare. HHS has already selected the drugs that will be negotiated in the initial round and as expected most of them are the high expenditure drugs in the plan.

The Republicans claim that these negotiations will decrease access to care and raise drug prices although there is no evidence that the VA negotiations have done that. They also claim that there will be reduced innovation, research and development, and job losses. They seem to have missed the overall picture that pharmaceutical companies in other countries succeed – even when there are negotiated prices with the health plan in those countries. Of the top 15 pharmaceutical companies in the world 8 are in the United States and the remainder in Switzerland, UK, France, Denmark, and Japan. The numbers given for fewer new drugs, fewer new indications, and drop in R&D spending seem highly speculative to me.  For example, the drop of $663B in R&D spending is the equivalent of about half of the total revenue for the top 15 companies.   I seriously doubt they are spending that much on R&D. During the 20 year period that I am referring to companies left entire therapeutic areas and it was common knowledge that marketing was going to drive pharmaceutical sales. There is an entire section about decreased jobs.  Are the Republicans really suggesting that Americans should pay (by far) the highest amounts for prescription drugs in order to fund a jobs program? And finally, the suggestion that the plan is “legally dubious”.  Apparently Congress is set up to help industries optimize profits rather than protect people who can’t pay a thousand dollars or more for a Medicare Part D copay.         

This post also has implications of pharmacy benefit managers or PBMs.  You remember them?  They are the business entities charged with “managing” your pharmacy benefits allegedly to make medications most “cost effective”.  PBMs make about $315 B annually for doing nothing more than managing prescription drug programs for employers and other large entities with health insurance programs. In practice they are a price multiplier rather than a price reducer.  PBMs control the spread or difference between what the insurance pays for a medication and what they reimburse pharmacies. In some cases, their reimbursement for pharmacies is lower than the actual cost of the medication. Since they are leveraging large number of patients, local pharmacies typically do not have much of a choice if they expect to do business – even though an affiliation with a PBM is draining. PBMs can own their own pharmacies and reimburse those pharmacies more than community pharmacies.   For a physician the most onerous aspect of PBMs occurs with prices for drugs and their positions on formularies for hospitals and clinics.  A formulary is a restricted list of medications available for physicians in that health plan to prescribe for their patients.  That can mean a patient has to change their prescription for it to be covered or some newer medication may not be covered at all.  During negotiations with manufacturers, PBMs can get a rebate from the manufacturer if they get their product exclusively in the formulary. That rebate is kept by the PBM rather than shared with the people paying for the drug.  

The pharmaceutical landscape is a minefield that is set up to optimize corporate profits. Pharmaceutical companies are essentially guaranteed high margins based on patent exclusivity and high prices.  PBMs generate a lot of revenue, add no value, and many pharmacists would add are a drain on their businesses. Let's face it - these businesses like most of healthcare in the US were essentially invented in Congress.  If they are not a recipe for making money - I don't know what is.  The Medicare Part D price negotiations through the Inflation Reduction Act is the first bright spot I have seen in a long time.  Republicans clearly want to maintain the status quo and that means extremely expensive medications and copays for anyone who is in the Medicare Part D coverage gap. If you were ever surprised by one of these copays like I was recently – support the Biden Administration’s attempt to control high drug prices.

George Dawson, MD, DFAPA

Supplementary 1:  An obvious point that I forgot in the original post in terms of backing Big Pharma is the idea that any physician would back limited access to a needed medication because of financial (rationing) restrictions.  Toward the latter half of my career, if anything physicians have made extraordinary efforts to get medications for their patients including having to manage large collections of samples and try to supply some patients from those samples.  Incredibly - some critics saw that as another perk from pharmaceutical companies that was corrupting physicians.  Some politicians on the other hand who are getting very large donations from pharmaceutical companies have no hesitation in suggesting that American patients should continue to pay exorbitant costs for pharmaceuticals - even if it means not being able to afford medication and compromised health.   

Supplementary 2:  Must watch video on regulatory capture or how Congress profits from disrupting free markets and establishing monopolies. Pharma and electronic health record (EHR) companies are cited examples, but there are additional examples including broadband and AI:

 https://www.youtube.com/watch?v=F9cO3-MLHOM

  

Never Miss An Opportunity To Harass A Physician

Despite some PR releases to the contrary, pharmacy benefit managers (PBM) continue to harass physicians and waste their time.  My latest inane conversation occurred after a pharmacy left their usual message about prior authorization and an 800 number about a prescription that I had written.  Unless I call the PBM and jump through all of the necessary hoops they will not cover my patient's prescription and it will likely go unfilled.  It was a newer medication and more importantly one that I had not started in the first place.  In other words, the patient had been maintained on this medication before seeing me.  That means the specific prescription had been approved from another physician a few months earlier.  I was writing this prescription because the patient did not have access to the previous pharmacy and I was the physician of record in another treatment facility.  The conversation with the PBM went like this:

PBM:  "Is this a doctor's office or a pharmacy?"
Me:  "Doctor".
PBM:  "Who is the doctor?"
Me:  "George Dawson"
PBM:  "Who are you?"
Me:  "George Dawson"
PBM: "OK - I was just checking.  What is your fax number?  I can fax you the form in 20 minutes"
Me: (fax number given)
PBM: "OK - you will need to complete the form and then fax it back to us and we will have 15 days to make a determination?"
Me:  "Do you understand that the patient needed this medication two days ago and I just got a notification about this today?"
PBM:  "That is the patient's policy.  We can do an expedited review and give you a determination in 3 days if you like?  But that is in the patient's policy.  We have either 15 days or 3 days to make a determination.  Do you have any questions about that?"
Me:  "Well no I do not.  I am only concerned about appropriate medical care and this delay is not appropriate medical care.  I don't care about your policies.  Your policies have nothing to do with appropriate medical care."
PBM:  "Is there anything else that I can do for you today?"
Me:  "No there is not."

I expected to receive the fax in 20 minutes but did not get it until the next day.  The form is designed to waste additional physician time.  It could have been pre-populated with all of my information and the patients information - but it was not and I had to complete the form by hand.  There were two sections on the form that had to do with failed medication trials.  One wanted specific dates.  Since I am a consultant I do not have specific dates and my experience with most patients is that they have a difficult enough time with the names of medications.  I do know that the patient had tried 8 different medications from the same class and stopped them due to lack of efficacy or intolerable side effects.  I added them to the section and wrote "refer to the previous section" on the redundant form.  Total time to complete the form and try to figure out what they wanted was 20 minutes.   I was seeing other patients it took me an additional 2 1/2 hours to complete the form and fax it.  The 72 hour clock started at that point but there was no place on the form to request an "expedited review".  

I have several posts about PBMs on this blog.  They all have the same modus operandi.  PBMs are at the very minimum a significant delaying action.  They are hoping that the physician, the patient, or both just give up and either withdraw the prescription or opt for a much cheaper generic prescription.  There are a couple of significant problems with that theory.  The first is that all generics in the same so-called drug class are not equivalent.  Any physician with a modicum of experience knows that individual patients have highly individualized responses to medications that are broadly similar and that there are generally sound pharmacological reasons for those responses.  Secondly, physicians have been prescribing less expensive generics medications for decades now and if a new unique medication is being prescribed the odds are very high that the person has not responded to that medication.  In the example given here,  I had a list of 8 medications in my record that failed due to intolerable side effects or a lack of efficacy.  They were all inexpensive generics.  I listed them on the form and faxed it back to them.

This behavior does highlight an important difference in ethics between physicians and medical businesses.  In every case where I prescribe a medication for a patient, the medication is carefully selected and monitored for how well it is tolerated and the effectiveness.  The ethical concept here for physicians is to provide continuity of care for the patient.  That is the reason that I am obligated to provide follow up prescriptions to patients who leave one care setting and go to another.  The PBM obviously has no similar constraint.  I would argue that their 15 or even 3 day policy ignores the fact that the patient needs the medication right now.  The telephone conversation makes it explicit - the company cares more about the policy than the patient who needs the medication.

The political process in all of this is frequently ignored.  How is it possible for a private company to waste so much physician time and interfere with patient care?  A long time ago the healthcare industry and its friends in government sold the American public on the idea that businesses should ration health care.  They sold that idea with rhetoric about how physicians were greedy and tended to squander health care dollars on unnecessary tests, surgical procedures and medicines.  They sold that idea in spite of the fact that the largest independent review organization of physicians documented a trivial amount of excessive resource use.  Businesses are now firmly entrenched as middle men whose only job is to ration health care and that includes prescription medications.  They do that in part by having physicians make tens of thousands of calls like the one outlined here every day and essentially leaving that physician and their patient in the lurch.

Health care businesses currently have the best of all possible worlds.  They are funded by mandatory health care insurance that is essentially the second largest tax on all Americans.  The annual health care premiums easily exceed property taxes, state income taxes, and state sales taxes for almost all Americans.  The does not include the amount of physician and patient time that is wasted by these rationing tactics.  In return Americans get a system of corporate management that consistently places the interests of the corporation and corporate profits ahead of them.  They talk like they are competitive businesses - but they are in fact some of the most heavily subsidized businesses in the US and nobody seems to make the connection between the most expensive health care system in the world and this corporate welfare.

It is well past the time for change and the first step should be to return medical decision making to physicians and stop pretending that a for-profit company cares more about patients than the monied interests of the corporation.


George Dawson, MD, DFAPA

How To Really Fix The Broken Mental Health System

A few weeks ago the Psychiatric Times posted an article called "How to Fix the Broken Mental Health System: Call For Suggestions."  I posted a link to one of my previous blogposts in the comments but decided to write a separate post here.  My reasons are several fold.  First off, any call for suggestions to me is really an invitation to generate web traffic to a particular site.  It is a standard tactic of bloggers.  For proof of that just Google the title and you will see hundreds of references in the last 2 years.  Second, I can do a better job and have done a better job here.  It gives me an opportunity to collect links under common themes.  Finally, it creates an opportunity to provide answers in one spot.  I may be wrong, but I think that the Psychiatric Times piece will be quickly forgotten.  Since hardly anyone reads this blog, that will probably also happen, but at least my thoughts are out there and include statements that you won't see posted by anybody else.   Here are  my point by point suggestions:

1.  Managed care and all that it involves including Accountable Care Organizations (ACOs), Pharmaceutical Benefit Managers (PBMs) and the Substance Abuse and Mental Health Services Administration (SAMHSA) must go.  It should be evident to anyone that these organizations have not contributed to cost effectiveness, innovation, quality or efficiency.  Instead they are largely responsible for an additional hidden tax on all Americans.  I am referring to the typical high deductible health insurance plans that results in thousands of dollars in copays and premiums before any health care has been received and the $250,000 in out of pocket costs that any 65 year old couple can expect to pay in additional health care costs.  Contrary to their advertising, managed care organizations disempower patients and their physicians and are the largest obstacle to care in this country.  Their disproportionate effect  on psychiatric and substance use disorder services has been well documented.

2.  Centers of excellence rather than collaborative care is the primary goal.  All of the managed care forces and their political backers in the first point above are making the argument that we cannot possibly produce enough psychiatrists to meet the need in this country.  They maintain that argument despite the fact that the US currently has about 1/4 the number of psychiatrists per capita as Switzerland, significantly fewer than 18 of 32 OECD countries, and is only 1 of 3 countries where the number of psychiatrists is decreasing.  Instead of developing a rational triage system, their solution has been to say that anyone can provide psychiatric services or that a psychiatrist reading screening checklists like the PHQ-9 is some kind of psychiatric care.   This is both an absurd characterization of psychiatry and a non-solution to the problem.  Psychiatric specialists need to be available to treat the most difficult to treat disorders.  They don't need to see everyone taking an antidepressant or everyone with insomnia.  They need to see people with difficult to diagnose problems and treatment resistant mood, anxiety, psychotic, neurocognitive, substance use, and psychotic disorders.   They need to see this population both for diagnostic clarification and treatment.  Centers of excellence need to be developed around these disorders and the associated treatment delivery.  There are current models that develop statewide systems of care around centers of excellence that seek to provide the highest quality of care to residents in that state.

3.  The administration of systems at the local level needs to be done from a clinical and not a financial point of view.  The split systems of care (administrative versus clinical) is one of many sources of poor quality care.   It has resulted in some situations as absurd as administrators believing that they can design systems of mental health care without input from clinicians.  This is especially problematic in treating patients who have  problems with aggression.  Psychiatric training needs to include specific instruction on how to clinically administer these systems of care.

4.  The psychiatric infrastructure needs to be rebuilt.  That includes both community and state hospitals.  Very clear criteria need to be established for admission to these facilities since state hospitals in recent times have been the only housing option for people with severe problems.  The concept of "treatability" has been inappropriately applied by federal regulators.  I worked for years as a Medicare reviewer and reviewed many state hospital records where I was asked whether or not the patient had achieved maximum benefit from hospitalization.  That would allow the administrative authority that I was working for at the time to deny any payment to the hospital from that point on.   The reality is that the patient was still severely disabled and could not live on their own, with their relatives, or in whatever residential facilities existed in the state.  Whether there was continued payment or not, there was no place to send the patient due to the presence of a chronic severe disorder.  That is still the problem today.  Rationing has resulted in a severely constricted infrastructure that does not match the needs of the patient population.  A state hospital system cannot exist in a vacuum.  There needs to be an established system of residential facilities apart from those hospitals that can accept people who may never acquire the skills to live in a group home setting or independently.

5.  An emphasis on independent living and competitive or supported employment needs to be the priority of any mental health system.  The community psychiatry movement introduced an important bias - that people with severe mental illnesses should always live independently rather than in an institution if possible.  That is a very important concept but it is time to move beyond that basic bias to a more comprehensive approach.  That includes not only the vocational rehabilitation aspects but a renewed emphasis on the cognitive and functional capacity aspects of severe mental illnesses.  We now have large detailed studies of cognitive deficits in groups of patients with schizophrenia, bipolar disorder and substance use disorders.  That knowledge has not been used to implement any innovative approaches to residential living or vocational rehabilitation.   Treatment rather than rehabilitative approaches to these deficits need continued emphasis and research.  The comprehensive treatment of any person with schizophrenia or a mood disorder should include an assessment of cognitive problems beyond the usual approach of treating symptoms.

6.  Increased availability of psychotherapy and case management services.  Medicalization has become a popular buzzword by journalists and critics of psychiatry.  If you ask any psychiatrist about the likely causes of increased prescribing and attempts to treat all problems with medications the likely response will be that there are no other resources left to treat the problems.  Many managed care systems have eliminated psychotherapists from their clinics or restricted access to available services.  Family and marital therapy is often not available at all.  Many counties have severely restricted the availability of placements for children with severe problems.   There are clear population based approaches that have not been implemented on a wide scale basis including computerized psychotherapy, brief cognitive behavioral therapies, mindfulness based therapies, basic behavioral approaches, and non-psychotherapy approaches like exercise.   These therapies can not only be applied to a wide variety of problems but also can be part of a rational triage system to reduce the prescription of medications and assure that psychiatrists are seeing only the most severe disorders.  This system would also be an asset to primary care physicians and provide them with viable options other than prescribing medications.

7.  Reform of the civil commitment process is necessary.  Civil commitment for involuntary treatment of mental illness and substance use problems is highly subjective and varies considerably from county to county within the same state.  That variance is largely due to variability in resources form county to county and interpretations of the statutes that generally are in line with the level of resources.  Civil commitment and associated legal functions such as conservatorship or guardianship can be life saving and life changing interventions.  A better infrastructure will give legal authorities more confidence that a viable intervention can be accomplished that will reverse the reasons why the person has entered the legal system.  But beyond that it has to be clear that managed care definitions of "dangerousness" and interpretations of "imminent dangerousness" are basically rationalizations to do nothing.  There also needs to be an avenue for preventing the incarceration of mentally ill and substance using patients for minor offenses and diverting them to treatment programs in the community.  Another area where legal interventions are critically needed is guardianship and conservatorship decisions for mentally ill patients in need of acute medical care.  Civil commitment, conservatorship, guardianship, and substitute decision makers all need to be rapid parallel processes done through the same probate court rather than different courts and different jurisdictions.  It is more likely that experienced judges and referees will be able to make better decisions.

8.  Better public health interventions for violence and aggression are needed.  There has been no progress in this area due to the political stalemate on gun control or gun access.  That never addresses the state of mind prior to the violent incident.  The necessary public health interventions need to come at that level and there needs to be centers where aggressive behavior can be addressed and treated before there are adverse outcomes.  Beyond that immediate need there is also very little dissemination of the information that is already known about childhood adversity and adult mental health outcomes.  There is so much critical information out there about the adverse impact of certain social experiences in childhood that are not public knowledge and that should be widely available.

9.   Pharmacovigilance and pharmacosurveillance services need to be developed in the same way that access to controlled substances prescriptions have been developed in many states.  We have been hearing about "Big Data".  Managed care systems have vast amounts of data that they consider to be proprietary that is analyzed from a business rather than clinical perspective.  Any clinician prescribing medications should get a monthly report on their prescribing patterns relative to all physicians and fellow specialists and subspecialists.  Statistical models of conservative prescribing and polypharmacy need to be developed.  Prescribing patterns associated with the highest complication rates need to be identified.   Feedback needs to occur at the level of the individual physician and the reports need an adequate amount of detail.  Literature based on data mining large PBM data bases is not useful to individual physicians.  With current pharmacy databases there is no reason why this system can not be developed nationwide.  

10.  Better neuroscience training for psychiatrists and psychiatric trainees.  We are past the point where a focus on pharmacology can inform a psychiatrist about how a prescription might affect brain functioning.  A detailed knowledge of signaling systems including many systems outside of the nervous system and how they affect plasticity is a requirement for the future.  A detailed knowledge of these systems is necessary to understand brain functioning and normal and abnormal conscious states.    There needs to be an emphasis on teaching neuroscience in psychiatric departments and correlating neuroscience with currently observed clinical phenomenon at a practical and theoretical level.

11.  Medical detoxification from substances needs to be widely available.  A lot of people forget that substance use disorders are in the DSM and there is a psychiatric subspecialty in Addiction.  Even though we have more addiction specialists than ever, the quality of acute detoxification is worse than ever largely because it is another rationed service.  People with significant withdrawal states are often sent home with a bottle of benzodiazepines or sent to a "social" detox setting with no medical supervision.  There are specific goals for detoxification from addictive drugs including the prevention of withdrawal seizures, the prevention of delirious states, the prevention of psychotic states, and the prevention of suicide during acute withdrawal.  It is a common expectation of the current system to expect a patient or their family to be managing withdrawal at home.   The secondary expectation of detox is to assist the patient with transitioning to a safe setting where they can stop using the drug they were just detoxified from.  My estimate from talking with primary care physicians is that only about 20% of the emergency departments and primary care physicians in any locale can refer people to functional detox units.  The non-medical powers that be in the health care system decided long ago that detox was  an "outpatient procedure."  In most cases the translates to sending a person home and hoping they will make it to an outpatient appointment or an AA meeting.

12.  The gross mismanagement of physicians has been a pathway to physician burnout, mass dissatisfaction, and a dumbed down assembly line approach to the practice of medicine and psychiatry.  Physicians don’t need to be told how many people to see in a day, what to document, or how to treat people.  The current collaborative care approach can be seen as being due (in part) to a mind numbing productivity approach that was invented by the federal government and the business world in the first place.   When I was trained as a physician, our teams knew what the resources were, knew what our tasks for the day were, and we could make a local resource allocation on that basis.  It was an extremely efficient way to practice medicine.  At some point, administrators developed “productivity” standards where physicians were expected to apply a totally subjective billing and coding scheme to a patient interaction and do that repetitively all day long.  There were rarely two interactions that were alike, but for the past 20 years physicians have pretended that they were and that this productivity concept had some real meaning.   Administrators could simply increase “productivity standards” to make it seem like more and more work was being done.  In some clinics this process reached an absurd level – 40 or 50 patients a day.  People with complex problems were being seen for minutes and physicians were going along with it because their salary depended on it.   Productivity is another managed care concept that needs to go. 

That is my top twelve list for fixing the broken mental health system.  They are obvious problems supported by my clinical experience.  They are consistent with the frequent problems I have had advocating for the resources I needed to treat patients with severe mental illness.  The government and business partnerships in health care have been obstacles to care.  As long as these partners continue to ration health care and siphon off large profits while rationing care and resources to the patients who are paying for them nothing will change.  This pattern has been most noticeable in psychiatric services.  Contrary to a lot of rhetoric, the problem with the mental health system is not the pharmaceutical companies behaving like other businesses.  It is not the DSM.  It can't be organized psychiatry because organized psychiatry is politically weak and ineffective.  It is not physician conflicts of interest because they are plentiful and the more important ones on the business side are never discussed.

This so-called system was brought to you by the government and the health care companies that lobby all politicians.  The idea that a system of medical care run by business people and politicians who know nothing about medicine or psychiatry is somehow a good idea, is an ongoing American pipe dream.

It is time for the country to snap out of it.


George Dawson, MD, DFAPA

Supplementary 1:  The photo credits here go to Ruzica Vuskovic, MD.

Supplementary 2:  I will be adding in links to previous posts at some point but ran out of time tonight.

Supplementary 3:  I added on Monday 11/17/2014.

WIll Integrity Save Psychiatry?

The answer is - it  depends on how it is applied.

In the last two days, I have seen the integrity argument pulled out.  Allen Frances is still using his bully pulpit on the Huffington Post, where it seems that anything critical of psychiatry is readily posted.  In this case, he used the text of a blogger and the timeline created by this blogger to illustrate how there was no disclosure of a conflict of interest by a group of researchers, one of whom was the chair of the DSM-5 Task Force.  The APA investigated this and acknowledged the non-disclosure of the conflict of interest.  Apparently the acknowledgement in the form of an apology from the research group and the investigation by the APA is not enough for these critics.  The blogger Dr. Nardo suggests that an "outside panel" be appointed to review his findings and the original materials again.  I cannot think of how an "outside panel" could be convened.  I have never really seen an objective analysis by an outside panel and wonder who might be selected.  And yes I am suggesting that any outside panel would naturally have a significant conflict of interest.  There appear to be many critics of psychiatry and only weak defenders.

He refers to a post by an anonymous web professional Neuroskeptic who summarized the state of things in his post as there being "no smoking gun."  He also concludes that the idea of a psychiatric critics benefiting from book sales with the same theme suggests "by which logic, every author in history has had a financial conflict of interest in their own ideas." As a student of conflict of interest that IS a logical conclusion, especially when I see links to two of Dr. Frances' books listed right below the Huffington Post article.  It is also an obvious fact that people routinely deny that applies to all human endeavors.  If I am heavily invested in any subject my "ideas" can be counted upon to be fairly subjective and consistent with my self interest whether that is academic or financial.  That is why I have read thousands of articles in Science, Nature, and medical journals in the past three decades and very few have panned out.  At a larger level it is why Ioannides could declare that most published research is false.  It is why you can count on seeing significant side effects from practically every medication approved by the FDA as safe and effective.  So yes, I am afraid that same standard applies to the critics as well as the people doing the heavy lifting and trying to prove something in the first place.  I would even take it a step further and suggest that the same transparency rules should be applied.  How much money can you make as a critic of psychiatry or the DSM?  My guess is plenty.

Both Dr. Frances and Dr. Nardo seem to be suggesting that all of the conflict of interest issues of academic psychiatrists and the way the APA handles them is sending psychiatry to hell in a handbasket.  This is a historically incorrect view of the dismantling of psychiatry in the United States.  Every day people in this country are getting inadequate psychiatric care.  It has nothing to do with the ethical behavior of academic psychiatrists.  It has a lot to do with the fact that the APA is not a very politically savvy organization and there are massive conflicts of interest interfering with the delivery of psychiatric care.  Here are a few scenarios:

1.  A depressed or psychotic but nonfunctional person is discharged from the emergency department because of a lack of "acute dangerousness" criteria.  The family is outraged but they are told: "Look there is nothing we can do because he/she is not imminently dangerous to themselves.  Upon further investigation the state has a "gravely disabled" criterion in the commitment statutes but it is practically never used.  They find that local hospitals and courts never use that criteria because the patients admitted are too difficult to treat and place.

2.  A person with acute alcohol and benzodiazepine withdrawal is sent home from the ER with a bottle of lorazepam and advised how to detoxify themselves.  They go home and take the entire bottle to get high.

3.  A person with alcoholism and depression is admitted for suicidal behavior.  She was intoxicated, depressed and staring at a handgun.  The next day the attending physician is contacted by a psychiatrist/utilization reviewer from the insurance company who has concluded the patient is no longer suicidal and they can be discharged.  He will no longer authorize payment for inpatient treatment. 

4.  A pharmacy benefit manager refused to refill a 2 week prescription by a patient's psychiatrist.  They have the pharmacist faxes a form to the psychiatrists office saying that they will only accept a 3 month prescription.  The psychiatrist takes time to explain first to the pharmacists and then 2 different people at the PBM (total time 30 minutes) the rationale for not giving a large supply of medication to a chronically suicidal patient.  The PBM refuses to change their position.

5.  A managed care company refuses to cover psychotherapy provided by a psychiatrist.  The psychiatrist explains that he is an expert in this type of therapy and the patient has been referred to him by the patient's primary psychiatrist.  The managed care company authorizes 3 "crisis sessions".  

6.  A person completes a PHQ-9 scale in their primary care clinic and they score an 18.  They see their primary care physician and say they would like to see a therapist.  They are told to take an antidepressant and to come back in two weeks to fill out another PHQ-9.  Total time of the visit is 5 minutes.

7.  A person is seen in their primary care clinic and in 20 minutes is told by their nonpsychiatric physician that they have bipolar disorder.  They are prescribed quetiapine, citalopram, and divalproex.  Within several days they are too sedated to function at work.

The are just a few examples of thousands of people everyday who are receiving grossly inadequate care based on a specific ethical principle of physician behavior.  That is the physician makes an assessment and prescribes care in what he or she believes is the best interest of the patient.  That is the contract.  There is no insurance company or government bureaucrat involved.  There is no restricted access to mental health care or pretending that primary care physicians are psychiatrists.  There is no remote "assessment" by a physician employed by a managed care company that prioritizes the financial well being of that insurance company or pharmacy benefit manager over the patient.  In fact,  I do not understand how that is ethical behavior at all.

That is the basis of the decline of psychiatry in this country.  It has taken a proportionately larger hit than any other specialty.  It is documented in detail on this blog and in E. Fuller Torrey's recent book.  The adventures or misadventures of academic psychiatrists are relevant only insofar as the APA seems to use the President of the APA as a position that academics cycle in and out of.  The idea that "psychiatrists in the trenches" are poorly represented by such a system is accurate with two possible exceptions that I can think of.  Psychiatrists in the trenches are also poorly represented by criticism of academic psychiatrists and their conflict of interest agreements and personal employment contracts.  It does nothing to address the central problems of the specialty, provides no tools that front line psychiatrist can use against all of the real conflicts of interest they face on a day by day basis, and is generally demoralizing.  Before any critics suggest that I am supporting a "whitewash" - put yourself in the position of a psychiatrist who has just put in a 12 hour day taking care of 20 inpatients and putting up with passive aggressive and aggressive MCO and PBM reviewers who have been wasting your time and interfering with your care.  You go home to read the paper and suddenly there is a major story of how unethical psychiatrists are - based on the appearance of conflict of interest.  You try to remember that last time you saw a CME event that was sponsored by a pharmaceutical company.  Then you check your files to make sure you have enough CME credits for relicensure.  As an added piece of information that same psychiatrist doesn't really care about Section 3 in the DSM-5 or the issue of dimensional versus categorical diagnoses.  They have not blinked an eye with the release of DSM-5 and won't in the future.

That is how the psychiatrist in the trenches experiences this academic exercise in conflict of interest.  I say if you want to pull out an ethical argument and use that to help front line psychiatrists, it needs to be focused on the obvious targets in managed care and the government bureaucracies that support them.

You know - the real forces dismantling psychiatry (very effectively I might add) over the past three decades.

George Dawson, MD, DFAPA

The Real Conflicts of Interest in Medicine and Psychiatry Today

I noticed some confusion around the GSK article that was recently posted.  I decided to start the New Year examining conflicts of interest (COI) in medicine and psychiatry because they are widespread.  These COI are much more widespread than the press or politicians have stated.  That is because there are more players than physicians involved and these other players are hardly ever mentioned. You would never realize that by reading the papers largely because COI is always described as a problem with physicians.  Nothing could be further from the truth.

My goal is to outline as many as possible and hopefully readers here will be able to fill in any that I might have missed.  Because I am just one guy working in his spare time, it will not be an encyclopedic listing but it will be more comprehensive than you will find anywhere in the press or possibly the existing medical literature.  It will also be more comprehensive than the typical political analysis that usually suggests that the only relevant conflicts of interest have to do with physicians making money or prescribing drugs in exchange for certain rewards.  As you will see, these may be some of the least important conflicts of interest.

A good starting point is this diagram I made that looks at all of the important conflicts of interest that impinge on physicians.  The diagram is not exhaustive. (click to enlarge)

Not all of the links are drawn and there are many smaller entities involved that have not been graphed. As you can see I have 13 major areas here that directly impact on physicians.  It is important to keep in mind the main goal or interest is the practice of medicine.  It flows from an ethical relationship with a physician.  That relationship is defined as the physician acting toward the patient in a way that is only in the best interest of the patient in exchange for a professional fee.  The modern relationship makes an important distinction in that the physician needs to be practicing scientific medicine.  The American Psychiatric Association (APA) has a policy statement with some useful definitions.  The APA defines the primary interest as "the highest level of evidence based practice, ethically based and scientifically valid research, and quality continuing education for the benefit of patients, the profession and society."  They define secondary or personal interests such as personal, financial, or professional that:  "may inhibit, distract, or unduly influence their (physicians) judgment or behavior in a manner that detracts from or subordinates the primary interest of patients and may be perceived by some as undermining public trust."  Six examples of situations that may require vigilance to prevent conflict of interest issues are given and 5 of 6 can be seen as derivative of physician relationships with the pharmaceutical industry.

The Institute of Medicine (IOM) definition of conflict of interest is: "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest."  Note that the IOM makes no distinction about conflict of interest versus the appearance of conflict of interest.  It turns out that the appearance of conflict of interest is the common standard that is used to indict the medical profession.  The classic example that is typically given in the media is the influence of pharmaceutical representatives on physician prescribing behavior.  The recent GSK disclosure confirms that that pharmaceutical representatives were paid based on the number of product prescriptions that the physicians they visited actually wrote.  The idea is that promotional items of widely variable value (pens to pizza to golf outings to trips) and free samples led to increased prescriptions.  Free samples provided to clinics was probably also a major factor and became a mainstay for many patients with limited or no mental health benefits.  Typical press coverage suggests that the results of this type of conflict of interest are widespread and certain, but I would suggest that the great majority of physicians including many of those who were paid consultants by the pharmaceutical industry were not laboring under any conflict of interest.

Consider for a moment the conflicts of interest (COI) listed across the top of the diagram starting on the left with Managed Care COI.  I have reviewed those conflicts of interest in great detail in previous posts.  As an example consider the conflicts of interest in this post on how physician employees are managed by managed care companies.  In all cases, there is a direct conflict of interest between physicians interest and the interest of the company and its managers.  In every situation that I am aware of the physicians lose.  That is typically viewed as a plus by the business managers running the company because it allows them to do whatever they want to do in terms of closing clinics and programs, firing physicians, firing support staff, coming up with business based performance metrics that are divorced from clinical reality, and denying care when they want to.  When the conflict is framed as entitled doctors being managed for the first time in order to be fiscally responsible - apart from the obvious rhetoric the real impact on patients is lost.   That has included the rationing of psychiatric services, the destruction of inpatient psychiatry services, the elimination of psychotherapy services, and the wholesale shifting of care for people with the severest forms of mental illness to deficient state operated services and correctional facilities.

Managed Care COI is almost always transacted by an army of intermediaries.  There are so-called physician reviewers or utilization reviewers who look at records from a distance and second guess physicians actually treating the patient.  They can say that they don't think a patient needs a particular service such as hospitalization and the patient is invariably discharged.  These days many hospitals owned by managed care companies employ non-physician case managers who function the same as utilization reviewers and tell physicians when to discharge patients from the hospital.  This review process represents what I consider to be the largest conflict of interest affecting the decision making process in medicine and it is the least transparent.  You are not likely to hear about it until you or a family member are hospitalized and you are told that it is "time to go" based on an insurance company decision.  You can see from the diagram that this COI is enmeshed with federal and state governments, think tanks, and some of the other managed care rationing tactics - Pharmaceutical Benefit Manager COI and Insurance Company COI.  All of these bureaucracies can produce insurmountable obstacles to physicians trying to care for patients by denying diagnostic and treatment modalities and denying appropriate settings for care.

Staying on the Managed Care COI for a moment what do some of the other relationships imply?  A full description of those relationships would require several books to explain.  This all started about 30 years ago as a concerted anti-physician movement.  Several political forces had an interest in making the argument that the reason for the high cost of American medicine was that physicians were greedy and they did too many procedures.  The federal government set up a complex subjective billing and coding system to slow down physicians.  It was a mechanism that could be used to investigate and prosecute anyone who seemed to be billing too much.  They initially enforced these totally subjective rules with the FBI.  At some point in the late 1990s, they allowed managed care organizations to internalize this process and control over physicians using this mechanism was handed off to managed care.  Today it allows a managed care companies to look at the documentation of patient care, decide that the notes don't meet criteria for a certain bill, and retrospectively demand payment for reimbursed services based on the number of other people seen for that problem.  The relationship between managed care companies and governments allows them to reimburse whatever they want for a service and demand back as much as they want.  No other professionals have private industry and governments stacked against them in this manner.  It is a motivating force for psychiatrists to not accept government backed insurance at a higher rate than other physicians.

Managed Care COI also means that it is practically impossible for a physician to appeal a decision by a managed care company.  The appeal is to another doctor who is employed by that company.  Any attempt to go outside of the company to a state insurance board is usually not productive.  State insurance boards are after all generally run by political appointees who are insurance industry insiders.  There are no neutral parties who are free of conflict of interest who can decide an appeal of an insurance company decision.

Practically all of the major entities represented on this chart operate in a similar manner to the managed care and insurance company conflicts of interest.  They are business entities who have woven themselves deeply into the political system at all levels and they can generally do what they want to do in terms of running the US Health Care system.  In most cases they treat physicians with impunity and tolerate professional groups only so far as they can co-opt some of their ideas and make it seem like they have an interest in quality care.  They have also used their influence to introduce cost-effectiveness rhetoric into places where it makes no sense.  That is especially true for psychiatric services where many have simply been shut down because they were not "cost-effective" enough.    

Some of the other entities on the diagram are more subtle.  Journalistic COI has a few sources.  Certainly journalists have no interest in patient care or treatment standards.  They do have an interest in selling stories and in some cases books.  They have an interest in influencing people.  Many of the stories I have commented on this blog over the past year were clearly rhetorical.  Many were also the product of ignorance.  Psychiatry is the only field in medicine, where non-experts don't hesitate to put their opinion in the New York Times and the New York Times doesn't hesitate to print it.  One of the most read posts on this blog in the past year was about a Washington Post article that I critiqued for many of these reasons.

Professional Organization COI is also an interesting one.  Consider the APA represents roughly 40,000 psychiatrists but only about 40% are actual members.  When the American Board of Medical Specialties decided that they would introduce a new and onerous procedure to certify physicians in an ongoing manner instead of for life, the APA clearly sided with the ABMS despite widespread dissatisfaction by the membership.  The conflict of interest considerations here are considerable and heavily financial.  There is no scientific evidence that the proposed ABMS recertification process is a valid approach.  There is certainly no evidence that a less onerous approach that would be less stressful to physicians would not achieve the goal of ongoing professional education and public safety.

The next time you read a story in the press about wealthy physicians being paid off to prescribe unnecessary medications or to perform unnecessary surgeries, pull up the COI diagram and print it out.  The truth is that physicians are caught in a web of conflict of interest.  Those conflicts of interest are generally set up to ration services to patients; ration or deny reimbursement to physicians; maximize the profits of middlemen (MCOs, HMOs, PBMs, Insurance companies); make politicians, think tanks, journalists and critics look good; and distribute a large chunk of the health care dollar to people who are not involved in providing the services.  The impact is the greatest by far in the area of psychiatric services but at some level it affects all of medicine.  The impact on physicians is also significant.  All of the pressures on physicians as a result of these conflicts of interest widen dissatisfaction with the field and increase burnout.  Both of those factors can potentially impact physician availability and intellectual resources necessary for optimal performance.  So if your physician looks burned out - he or she may well be.  It is probably directly related to doing an additional 2 or 3 hours of work every day to satisfy the requirements of all of these extraneous conflicts of interest.  Of course that is all generally unreimbursed time.  How would most workers react to putting in a full day and then an additional 2 - 3 hours off the clock to satisfy the requirements of some outside company?  It is like working for free for another company.

That is the real cost of conflict of interest and one of the reasons that health care premiums are essentially another tax on all Americans.

Happy New Year!

George Dawson, MD, DFAPA

Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Conflict of Interest in Medical Research, Education, and Practice. Washington (DC): National Academies Press (US); 2009. Available from: http://www.ncbi.nlm.nih.gov/books/NBK22942/