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

  

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?

Asthmatics Held Hostage

I never thought in my wildest dreams that I would end up paying $275 for 0.3 mg of epinephrine.  My allergist told me that the range of the patients he sees is about $150-200.  My allergic friends tell me that in some cases they are paying as low as $80 depending on insurance coverage.  Most Americans are on high-deductible insurance plans like I am.  That means that for the first half of the year or longer - expect to pay the full retail price for medications.  Despite the fact that the price of the autoinjectors has skyrocketed in the past few years, they still contain just a few dollars worth of drug in a fancy injector.  Most people who have anaphylaxis experience occasional reactions when exposed to a certain allergen and do not need to use the pens on a routine basis.  They are warned that the pens expire at a certain date and need to be replaced.  A 2014 paper (1) that looked at an emergency department intervention for anaphylaxis commented on the costs of the auto-injector weighed against both inadequate treatment of anaphylaxis and the potential adverse consequences of administering the wrong dose.  They looked at Average Wholesale Price (AWP) of the autoinjector containing 0.3 mg and 0.15 mg doses of epinephrine ($75.00) and a 1 mg vial of 1:1000 epinephrine ($3.00).  Obviously if you are having an anaphylactic reaction it is useful to have a viable and easily usable form handy to address the problem.  On the other hand what is it about packaging that results higher costs?  Until recently there has been no competition for epinephrine auto-injectors.

The other factor driving the cost is that manufacturers and insurance companies know that patients who need this device are over a barrel.  They need the medication and will pay for it.  If a steep copay or paying retail price due to a deductible is required - many will pay that price rather than risk death.  I said many because the high price of the auto-injector is preventing some patients from refilling their prescriptions.  A letter (2) found that only 40% of adults and teens and 60% of children refilled the auto-injectors at the appropriate time and suggested that cost may have been a factor.  In many ways this could be viewed as an unintended consequence of high deductible insurance and contrary to the pop economic theory that consumers will be more price sensitive when they are spending their own money.  That can only happen when there are price competitive products.

For that reason I have included the Advair Diskus Inhaler.  I have suggested in previous posts that asthma and most severe mental illnesses have a lot in common because of complicated genetics, diverse mechanisms, phenotypic heterogeneity, poor treatment response and chronicity.  Contrary to what most of us were taught in medical school most asthmatics are symptomatic.  Although many of the precipitants of worsening asthma control are known - there seems to be very little interest in doing much about it.  From a marketing standpoint that creates a lot of demand for products to address those issues.  Although there is no clear evidence that one product is superior to others,  Advair Diskus Inhalers have demanded a large market share.  During some recent years they have sold over $13 billion of product in a market where one billion in sales is considered a blockbuster drug.  In 2013, it was the third highest in pharmaceutical sales.  The inhaler pictured at the top of this post cost me $345.  The critical deductible period of my health insurance plan is the reason why I am paying that much cash to take a medication that I take all year long.  Once again it is all in the packaging.  The patent on the fluticasone/salmeterol drug combination ran out in 2010.  The unique disk delivery system remains on patent until mid-2016.  There is still debate about what will constitute a generic substitute.

I think that there are valuable lessons in the marketing and sales of both Advair Diskus and EpiPen that are relevant now that pharmaceutical sales are spiking again.  There is also a valuable lesson about the "market forces" argument for high-deductible insurance.  Packaging alone in these two cases is enough to capture all of that $3000-6000 deductible from anyone who wants to keep taking a prescribed medication.  It also illustrates that rather than being an intermediary for cost effectiveness, insurance companies are much more likely to step aside, and let their customers absorb the  full retail cost of a medication rather than negotiating better prices with manufacturers.  It may take a while for an American public that has been accustomed to Big Pharma and physician conspiracy theories to realize what is really going on.

There is also an associated lack of data on exactly how much people are paying.  I have been describing health care costs as a hidden tax (even before the Obamacare penalty) because it easily exceeds property taxes for most people and is their second highest expenditure after income taxes.  A recent paper by the Urban Institute backs that opinion up with data.  The authors looked at health care costs based on income as a percentage of the Federal Poverty Level (single person = $11,770, 2 person family = $15,930).   The authors looked at a simulation of various income brackets for people enrolled in Affordable Care Act (ACA) compliant non-group plans.  They found that people in both the median and 90th percentile in each bracket pay substantial amounts for premiums and out-of-pocket expenses as a percentage of their income.  As an example, a couple earning 300-400% of the FPL earns about $48,000-$64,000 per year.  At the median income they would pay 14.5% of their income for health care premiums and out-of-pocket expenses.  At the 90th percentile, they would pay 22.2% of their income.   According to this simulation, only those at < 200% of the FPL or > 500% of the FPL would pay less than 10% of their income toward health care expenses.  The range for all two person families was 10.8-13.4% for incomes of $32,000 to $80,000 per year.   That number easily exceeds the average nation wide property tax figure of $2,800 per year.

The title of this post was intentionally dramatic.  I hoped to illustrate just how incredibly expensive health care costs are here in the United States.  I encourage rethinking some of the issues related to this cost.  In this post, it is apparent that business leverage still carries the day.  The pharmaceutical and insurance/managed care businesses can still make as much money as they want to.  It is possible by the pharmaceutical funding and insurance rules that exist out there and of course they are all approved or written by business friendly politicians.  The second shocking fact are the estimates of health care cost for middle income Americans as 10.8-13.4% of their income.  That easily exceeds property tax costs and for most Americans it also exceeds their state income tax bill.

That leads me to conclude that health care costs are really the second largest tax on all Americans, exceeded only by federal taxes.  That fact should stop anyone in their tracks and lead them to think about all of the free market rhetoric and the relationship between this industry and Congress.  It should be clear that there really is no market competition or savings as a result of the current managed care system.  The only management that is being done is managing to put a significant portion of your personal finances in the control of the healthcare industry.  The best solution is to get rid of this system rather than continue to tax Americans to subsidize companies whose products have value only in an artificially inflated marketplace - inflated by this health care tax.       


George Dawson, MD, DFAPA

References:

1: Manivannan, Veena et al. “A Multifaceted Intervention Increases Epinephrine Use in Adult Emergency Department Anaphylaxis Patients.” The Journal of Allergy and Clinical Immunology. In practice 2.3 (2014): 294–299.e1. PMC. Web. 30 Jan. 2016.

2: Westermann-Clark E, Fitzhugh DJ, Lockey RF.  Increasing cost of epinephrine autoinjectors. J Allergy Clin Immunol. 2012 Sep;130(3):822-3. doi: 10.1016/j.jaci.2012.06.018. Epub 2012 Jul 22. PubMed PMID: 22828415.

3:  Linda J. Blumberg, John Holahan, and Matthew Buettgens.  How Much Do Marketplace and Other Nongroup Enrollees Spend on Health Care Relative to Their Incomes?  Robert Wood Johnson Foundation; Urban Institute.  December 2015.  Accessed on January 29, 2016.

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/ 

GSK Eliminates Appearance of Conflict of Interest - Who Is Next?

Glaxo Smith Kline came out with a major announcement a few days ago.   It will no longer pay doctors to promote its drugs and it will no longer tie the compensation of its sales force to the number of prescriptions written by doctors who have been detailed about those drugs.  These are both standard practices in the pharmaceutical industry and this is the first announcement of its kind within the industry.  GSK will continue to to provide "unsolicited independent educational grants" to educational institutions or medical societies.  Pharmaceutical reps will be paid on the basis of technical knowledge and customer service rather than sales.  GSK has been fined heavily lately about promoting off label use of its products and is currently under investigation in China.

My immediate reaction to the piece was "good riddance".  For the past decade there has been no bigger issue in psychiatry than the appearance of conflict of interest with the pharmaceutical industry.  Psychiatry has been targeted more than any other medical specialty by prominent politicians, the news media, and even by psychiatrists themselves.  There are endless blogs and opinion pieces about how the practice of psychiatry has been defined by this appearance of conflict of interest.  There are several blogs out there that have gained prominence by endlessly reviewing all of these details. It has affected the way the APA does business.  It has affected the way local district branches do business.  In the end the politicians are grandstanding on it, because the PPACA (Obamacare) will apparently list any physician receiving money from a pharmaceutical company.  That was suggested as a motivating factor in the NY Times article.  Those public lists have existed in some states like the one I have practiced in for years.

To me the arguments have always come down to advertising and ethics.  From an advertising perspective would we expect people to be affected by product advertising?  Of course we would.  The buying habits of the American population are shaped by advertising.  Selling products is more of a science than people think.  The American public can easily change its buying habits and can purchase products that are unnecessary and will be discarded after a brief period of time.  They can also be sold on products like junk food that are unhealthy but designed to be sold in large quantities.  Advertising would not seem to be the ideal basis for marketing drugs to physicians, but with many new products  physicians are now bypassed and the drug is sold directly to the consumer.  If the epidemiology  of a particular problem like "low-T" is known, direct-to-consumer marketing probably leads to many, many more physician visits than a physician suggesting to their patient that they probably have primary or hypogonadotropic hypogonadism.  All a patient has to do is go to the web site and take a non-specific checklist quiz on the features of "low-T" and be in their doctor's office to get the levels done within a week.  Things will probably go a lot smoother without a physician intermediary in the loop and I am sure that much physician behavior will be shaped by the onslaught of men coming in to be tested for "low-T".  I know for a fact that psychiatrists are approached for this problem because of the overlap between the syndrome and depression.

Part of the advertising argument has always been that there are unconscious factors in play.  Really?  That is the basis for all advertising in general.  The main difference has been that pharmaceutical representatives have been schooled on the relationship aspects of the sale.  They have been taught that basically if a physician likes them or feels indebted to them for free food, trinkets like poor quality pens that never seem to write very well, a round of golf, or tickets to the Lakers game that they may be more likely to prescribe their product.  Most physicians were apparently naive enough to not realize that there was a huge marketing database out there that tracked their prescription writing to see if they were writing the required number of prescriptions for that product.  In the real heyday of marketing bonuses to physicians, companies would pay for travel to important meetings.

While the people focused on the advertising influence kept chipping away mostly at psychiatrists, they seemed to ignore two important developments that made detailing or selling to individual physicians much less relevant.  The first was restricted formularies.  I was on the Pharmacy and Therapeutics Committee (P&T) of one of the largest health plans in the state and an affiliated hospital for a total of 10 years.  During that time, the predominant factor in the decision about whether to put a drug on a formulary that would make it available to prescribing physicians was the cost.  There were very few instances where a drug was so unique that it was made available even if it was very expensive.  In those cases a drug might be available for an incurable illness that had a negligible benefit but it was included basically for public relations.  One of the other overriding themes of the P & T Committee was that all drugs in a particular class (like antidepressants) were equivalent and therefore the least expensive drug in the class could be substituted for anything else.  This potentially led to a lot of unnecessary chaos when medications fell out of favor due to pricing and patients needed to be shifted en masse to the least expensive drug.  It gave hospitals and health plans leverage in dealing with pharmaceutical companies, but in some cases the deals were complex.  As an example, in order to get a new blockbuster drug at a good price, the health plan would need to accept the same company's generic in a different class that had been removed because it was considered too expensive.  Over a decade ago, business entrepreneurs decided that there was money to be made rationing medications to health plan enrollees and now a lot of that is done by pharmaceutical benefit managers (PBMs).  PBMs are currently a multibillion dollar industry.

The second important development was generic drugs.  Practically all of the blockbuster psychiatric medications of the past two decades are now generic drugs.  Many generic drugs are easily affordable even as direct out of pocket purchases.  At that point they are no longer actively marketed by the pharmaceutical company that held the exclusive patents.  They are more likely to be the preferred drugs of PBMs and health plan formularies.  They are in that role because of a scientific approximation.  That approximation is that all drugs in a certain class, like antidepressants that have the same purported mechanism of action are equivalent and one can be substituted for another.  That is clearly false but it allows the health plan to to provide you with the least expensive medication or charge you a hefty copay for one that is not.  It also seems to not consider after market information that can even affect generic drugs.  The best example I can think of there is the FDA warnings on citalopram.  I would guess that despite the warnings, it remains a preferred drug by most health plans.  Health plans in general seem to be geared up to prescribe antidepressants at higher and higher rates.  I would take it a step further and venture a guess that most health plans have not taken a look at the data in their systems on whether or not they have observed problems related to the FDA warning on citalopram.

The ethical argument goes something like this.  Physicians should have the best interests of their patients in mind and an advertising based conflict-of-interest to prescribe a certain drug creates an ethical concern.  On the face of it, it seems like a straightforward argument.  But there are several problems with it.  For example, what is the direct evidence that this occurs - if any?  Is it really believable that a physician would prescribe a decidedly suboptimal medication to a patient based on schmoozing with a pharmaceutical representative?  There are often other factors in play.  It is common to treat people with chronic illnesses who have suboptimal response to the current therapy and who are looking for the "next biggest thing" to try.  A physician who has been detailed on the "next biggest thing" is likely to prescribe it if asked.  There is a similar dynamic with the issue of overprescribing in general.  If a patient persists in their request for an opioid, an antibiotic, a stimulant or any other drug are they likely to get it?  The recent declaration that the CDC initiative to decrease antibiotic prescribing has failed would suggest that they will.  Finally there is the dynamic of "see the doctor and leave with a pill."  There are any number of scenarios where medications are used in medical practice and other options are not even discussed.  The psychiatric cases are highlighted but it happens as frequently in cases of mild diabetes mellitus, back pain, chronic pain of various causes, hypercholesterolemia, mild hypertension and others.  Many people have described this as "the doctor was poised over his prescription pad" but the healthcare industry is set up to see people in brief medication focused visits and physician reimbursement is tied to it.   There are also patient related factors and a recent Tom Hanks interview is illustrative.  He was on a late night talk show discussing his recent diagnosis of diabetes mellitus and he said his physician told him that if he could get back to his high school body weight he probably would not have it.  His reply was: "Well I'm going to have Type II diabetes."

The ethical arguments, especially the ones I have seen constructed by physicians also ignore the general case of conflicts of interest at the professional level.  Practically every major university department allows its faculty to supplement their salaries by consulting in private industry.  In many cases that is a major source of additional income.  In some cases those professionals are involved in setting standards and their approach is much different than the wall that is currently being constructed between the medical profession and the pharmaceutical industry.  As an example, academic and industry professionals within the engineering profession are often on committees responsible for setting standards that govern all of the products within that industry.  Their approach is to include as many industry professionals as necessary rather than suggesting the academics can set the standards themselves.  Considering that pharmaceutical companies employ some of the top scientists in the world it would seem that medicine has a lot to lose if it goes along with the prevailing assumption.  The prevailing assumption is that physicians are powerless to stop prescribing expensive medications that are of questionable benefit for their patients based solely on advertising and no scientific merit.

I applaud the GSK decision even though the above cited factors would suggest that for most physicians it has only historical relevance.  I would encourage all of Big Pharma to adopt the same policies toward physicians.  But this doesn't really go far enough and it is basically a token gesture at this point.  To really make a difference I would suggest that they stop giving money to politicians.  GSK spent $1.9 million on candidates and $4.9 million in lobbying last year.  All of that money was directed at a few politicians.  It is a part of a massive industry wide contribution to politicians.  What do you think buys more influence, giving free pizza and pens to doctors or giving thousands to tens of thousands of dollars to politicians?

George Dawson, MD, DFAPA


Katie Thomas.  Glaxo Says It Will Stop Paying Doctors To Promote Drugs.  New York Times December 16, 2013.

Stigltiz Commentary and The Implications for the Politics of Psychiatry

Nobel prize winning economist Joseph Stiglitz came out with a recent commentary of the economic recovery and why things are not a rosy as they seem.  He points out that many of the structural problems with the economy including predatory lending and credit, abuses by the credit card industry and abuses by the credit reporting industry are still in place.  In addition there are inadequate capital reserves and no real limits on the kind of low risk speculation by certain parts of the financial services industry - the basic problem that started everything 5 years ago.  I have been posting in political forums for the past 15 years that the American economy at times seems to be based on a fantasy rather than the way a real economy should work.

We have taken an alleged retirement system (401K, 403B) and turned it into a windfall for the financial services industry.  Instead of an actual retirement system, we find that the average American is not able to put away nearly enough to retire and in the process ends up paying significant fees to financial services companies.  In return for these fees they receive the standard boilerplate about no guarantee against losses and frequently have very poor investment choices since they are determined by their employer.  At the same time, low risk retirement vehicles like money market funds are paying negligible amount of interest.  Rather than being a reliable retirement system this is essentially another tax on the American people to fund the financial services industry.  Retirees are left with the option of accumulating cash only or putting their retirement funds at significant risk all of the time in order to accumulate enough capital to retire.

We are in the process of starting a huge health care mandate know as the PPACA or more popularly as Obamacare.  It will create a large influx of capital into the healthcare system based on coverage mandates.  The American health care system is currently the most expensive system of health care in the world.  The standard model used by the federal and state government has been to use managed care companies as intermediaries to contain costs.  There should be no doubt that model is a near total failure.  Recent data for example suggest that a couple nearing retirement should have an additional quarter of a million dollars saved for health care expenses during retirement beyond the cost of Medicare.  The health care system in this country can be viewed as a second tax on the American people.

How do Americans end up with two additional taxes being levied on them in addition to the usual income, Medicare, Social Security, sales, and property taxes?  How does it happen when we have a supposed radical element of one of the major parties working on fiscal responsibility?  I think it comes down to one American institution and that is the US Senate.  The Senate is full of aging, wealthy politicians who have worked for years to develop a power base in Washington and keep it.  They are completely out of touch with what the American people need and pass laws that will largely benefit the businesses that they are heavily lobbied by.  In some cases, they wrote the laws to invent the industry.  The disconnect of this group from the public was evident during the recent stand off to shut down the government and nearly default on our creditors.  In other words they risked the world economy to make a point instead of fairly representing what the average American wanted at that time.

How does all of this apply to the politics of psychiatry?  I can illustrate by looking at a few seminal events that apply to all front line psychiatrists and how their professional organization - the American Psychiatric Association (APA) responded:

1.  Managed care and the disproportionate rationing of psychiatric services:  Apart from Harold Eist, MD and a recent lawsuit against a managed care company there has generally been silence on this issue.  Some literature was generated regarding how to work with meager rationed resources but nothing about how to fight back as managed care became a government institution.  The APA's support of collaborative care means we have come full circle and the APA is explicitly backing a managed care model that involves treating patients without actually seeing them.

2.  The response to accusations of conflicts of interest related to the pharmaceutical industry:  There was a well known initiative against some prominent psychiatrists, the motivations for that initiative are still unknown.  It is well known that many academics in many university departments have contracting arrangements with industries in order to supplement their salaries.  It is well know that some professions charged with determining industry standards insist on industry representation in meetings where those standards are written.  It is known that many professional organizations got more support from the pharmaceutical industry than the APA.  The response to the attack from a Senator was to basically acknowledge that his attack was accurate and proceed with an appeasement approach that allowed critics of psychiatry to use this as additional rhetoric against the profession and any psychiatrist with a contracting arrangement.

3.  The Maintenance of Certification (MOC) issue:  This issue was forced by the American Board of Medical Specialties (ABMS) based on limited research.  The APA immediately aligned themselves with the ABMS despite considerable complaints and a petition by the membership.

The three examples given about are some of the main political issues for psychiatry, particularly the average working psychiatrist and the APA.  To say that the interests of most psychiatrists are not represented by the APA is a massive understatement.   Like the U.S. Senate, the APA seems almost totally disconnected from the people it is there to represent.  I have heard many reasons over the years about how the actual structure of the APA is the problem.  But nobody seems to want to remedy that problem.  I attended a seminar at one point where an APA official explained the MOC issue and how it would actually create a financial burden for the American Board of Psychiatry and Neurology (ABNP), despite the obvious fee generation to take a commercially monitored and administered test.  If it really is that burdensome -  why do it in the first place?  The initial rationale was that the public demanded it.  It seems that there is now solicitation for public support.  Who would not support an initiative to improve the competency of doctors - even if there is absolutely no evidence that a multiple choice exam with a high pass rate does that?

I think it is highly likely that the political structure of the APA is very similar to the political structure of the Senate.  While there is no lobbying there are ideas and affiliations based on those ideas.  Any political structure that is so far removed from what its constituents want it driven by cluelessness, conflicts of interest, or a divine mandate.  It is only logical to conclude that like the Senate, the issue is conflicts of interest.  In the 21st century, patriotism is no longer the last refuge of a scoundrel - accountability is.  The APA would do well not to follow the Senate on that course.

George Dawson, MD, DFAPA

Joseph Stiglitz.  5 Years In Limbo.  Project Syndicate, October 27, 2013.

Psychiatrists work for patients - not for pharmaceutical companies

That should be obvious by anybody reading this post but it clearly is not. I have already established that there is a disproportionate amount of criticism of psychiatry in the popular media compared with any other medical specialty. The most common assumption of most of those critics is that psychiatrists are easily influenced by pharmaceutical companies or thought leaders who are working for pharmaceutical companies. There are many reasons why that assumption is incorrect but today I want to deal with a more implicit assumption that is that there is a drug that is indicated and effective for every medical condition.

In the field of psychiatry this marketing strategy for pharmaceuticals became prominent with the biological psychiatry movement in the 1980s. Biological psychiatrists studied neuropsychopharmacology and it followed that they wanted to apply their pharmaceuticals to treat human conditions. At the popular level initiatives like National Depression Screening Day were heavily underwritten by pharmaceutical companies and the implicit connection was that you could be screened and be treated with a medication that would take care of your depression.

From the perspective of a pharmaceutical company this is marketing genius. You are essentially packaging a disease cure in a pill and suggesting that anyone with a diagnosis who takes it will be cured. The other aspects of marketing genius include the idea that you can be "screened" or minimally assessed and take the cure. We now have the diagnosis, treatment, and cure neatly packaged in a patent protected pill that the patient must take.  The role of the physician is completely minimized because the pharmaceutical company is essentially saying we have all the expertise that you need. The physician's role is further compromised by the pharmaceutical benefit manager saying that they know more about which pill to prescribe for particular condition than the physician does. That is an incredible amount of leverage in the health care system and like most political dimensions in healthcare it is completely inaccurate.

The pharmaceutical company perspective is also entirely alien to the way that psychiatrists are trained about how to evaluate and treat depression.  Physicians in general are taught a lot about human interaction as early as the first year in medical school and that training intensifies during psychiatric residency. The competencies required to assess and treat depression are well described in the APA guidelines that are available online.  A review of the table of contents of this document illustrates the general competencies required to treat depression. Reading through the text of the psychopharmacology section is a good indication of the complexity of treating depression with medications especially attending to side effects and complications of treatment and decisions on when to start, stop, and modify treatment. Those sections also show that psychopharmacology is not the simple act that is portrayed in the media. It actually takes a lot of technical skill and experience.  There really is no simple screening procedure leading to a medication that is uniformly curative and safe for a specific person.

The marketing aspects of these medications often create the illusion that self-diagnosis or diagnosis by nonexperts is sufficient and possible. Some people end up going to the website of a pharmaceutical company and taking a very crude screening evaluation and concluding that they have bipolar disorder. In the past year, I was contacted by an employer who was concerned about the fact that her employee had seen a nonpsychiatrist and within 20 minutes was diagnosed with bipolar disorder and treated with a mood stabilizer, an antidepressant, and an antipsychotic medication. Her concern was that the employee in question could no longer function at work and there was no follow-up scheduled with the non-psychiatrist who had prescribed medication.  Managed care approaches screening patients in primary care settings increase the likelihood that these situations will occur.

The current anti-psychiatry industry prefers to have the public believe that psychiatrists and their professional organization are in active collusion with the pharmaceutical industry to prescribe the most expensive medications.  In the case of the approximately 30 antidepressants out there, most are generic and can be easily purchased out-of-pocket.  Only the myth that medications treat depression rather than psychiatrists keeps that line of rhetoric going.

George Dawson, MD

American Psychiatric Association.  Practice Guideline for the Treatment ofPatients With Major Depressive Disorder, Third Edition. 2010

Antidepressants - the limited analysis of a polarized argument

The current President John Oldham and President-elect Jeffrey Lieberman of the American Psychiatric Association came out with this press release today on a 60 Minutes episode characterizing antidepressants as no better than placebo.  They describe this characterization as “irresponsible and dangerous reporting” and “a message that could potentially cause suffering and harm to patients with mood disorders.”

It is good to see the APA finally taking a stand on this issue.  Antidepressants and the psychiatrists who prescribe them have been taking a pounding in the popular press for years.  The main proponent here was also featured in a Newsweek headline story two years ago.  This is a prototypical example of how the media and special interest groups can distort science and facts and politicize the discussion that must be nuanced.  The problem is that you have to know something and be fairly free of bias to participate in a nuanced discussion.  Like most issues pertaining to psychiatry, the issue is always polarized and poorly discussed in the media.

I got involved in this issue as a managing editor of an Internet journal and I solicited a paper from a world renowned epidemiologist to get his current view on antidepressant meta-analyses. In order to present the entire argument I also solicited response from a world renowned psychopharmacologist with broad expertise in this field. Both articles are available online for free and I think if they are both read in total they represent the most accurate picture of antidepressant response.  Both references are listed at the bottom of this page.

Rather than get into the specific details at this point I will say that it was extremely difficult to find a anyone willing to provide a rebuttal to the to the original article by Ioannidis, but anyone who reads that paper by Davis, et al and who follows the antidepressant literature will have a greater appreciation of the effectiveness of these medications.  I hope to post some information on the statistical analysis as well.  At some level people tend to view statistics as a hard mathematical science and there is plenty of room for interpretation.  The use of meta-analysis is a common approach to these problems and a detailed look at the shortcomings of meta-analysis are seldom discussed.  That might explain why one meta-analysis shows minimal effects and another shows that there might be some antidepressants with unique effectiveness (see Cipriani, et al)

A final dimension that is critical in the analysis of any source is potential conflicts of interest.  The only conflict of interest that is typically discussed is the financial interests of authors and pharmaceutical companies in producing positive trials.  That ignores the fact that many of these trials have been very public failures and that post trial surveillance limits the use of some of these compounds.  There are other conflicts of interest to consider when an author is selling a viewpoint and can potentially profit from it – either financially or politically.

The APA could provide a valuable service here in making the documents from the FDA and the EMA widely available for public discussion and analysis.

George Dawson, MD

 “60 Minutes” Segment on Antidepressants "Irresponsible and Dangerous" – APA New release Febrary 22, 2012.

Ioannidis JP. Effectiveness of antidepressants: an evidence myth constructed

from a thousand randomized trials? Philos Ethics Humanit Med. 2008 May 27;3:14.

Davis JM, Giakas WJ, Qu J, Prasad P, Leucht S. Should we treat depression with drugs or psychological interventions? A reply to Ioannidis. Philos Ethics Humanit Med. 2011 May 10;6:8.

Cipriani A, Furukawa TA, Salanti G, Geddes JR, et al.  Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis.  The Lancet - 28 February 2009 ( Vol. 373, Issue 9665, Pages 746-758 )