The Increasing High Cost of Generic Drugs

With all of the drama about high pharmaceutical drug prices, the marketing behavior of the Big Pharma biz, and the medicalization of American society - there has been very little said about the generic drug business.  I discussed it in this piece about the DSM-5 and an absurdly high anti-depressant profit attributed to the pharmaceutical industry.  One of the highlights was how inexpensive some of the most well researched and recommended  antidepressant drugs were.  Then just this weekend I got a call from a friend who was taking an antidepressant who told me that his cost went up by 25% on the medication he was taking on the same insurance plan.  As any psychiatrist knows it is practically impossible to advise a patient on what they will end up paying for an extended release version of venlafaxine, even though it has been generic for a while.  Any attempt to find out online results in a confusing blend of American and Canadian prices.  Some of the Canadian prices on the same list exceed what would be paid in the US.

I caught an article by Hirst, reproduced in my local paper this weekend.  She describes a patient who was taking generic carbamazepine.  Carbamazepine has been generic for years.  I can recall prescribing the generic 15 - 20 years ago for patients with bipolar disorder.  This patient had been taking the medication for epilepsy and getting the drug through Walgreen's Prescription Savings Club.  He was paying $20 for a three month supply, but recently the price increased to $100.  That forced him to buy it on a month to month basis.  My drug information suggests at least 5 generic manufacturers and the original name brand along with a sustained release patented version are all on the current market.  Senator Bernie Sanders (I-Vt) is quoted:  "....We wanted to know if there was a rational economic reason as to why patients saw these price increases or whether it was simply a question of greed?"  The federal government tightly regulates health care with special attention from the Department of Justice - how could dramatic price increases in the face of ample competition be a matter of greed?  Wouldn't there need to be a cooperative effort on the part of all competitors to drive up the prices that fast?  The article cites "raw material shortages, consolidation in the industry and medical advances that make replicating brand name drugs more expensive".  I don't accept that explanation any more than greed.  One of the most expensive medications to manufacture in recent times was atorvastatin.  When it first came out, I spoke to a scientists involved in the production and he told me what it cost per pill to manufacture.  That cost was a small fraction of the overall prescription price.  That leads me to believe that even a $4/month prescription for ranitidine can lead to profits for a generic manufacturer.

The Hirst article quotes a pharmacy benefit manager as saying that average cost of a generic drug prescription has increased from $14.21 in 2005 to $41.88 in 2009 and that 1/3 of available generics cost more than $100 per prescription.  Another consultant suggested that acquisition costs of pharmacies have increased 17,700% in the past year.

A more academic article is available from the New England Journal of Medicine by Alpern, et al.  Those authors look at the specific example of albendazole, a broad spectrum anti-parasitic with a long expired patent.  In 2010, the average wholesale price (AWP) for a single day dose was $5.92.  By 2013 it was $119.58.  The authors look at the National Drug Acquisition Costs file and cite a number of significant price increases in widely known generic drugs including captopril, clomipramine, digoxin, and doxycyline.  They have produced an excellent graphic that looks at the number of prescriptions and global Medicaid budget for mobendazole and albendazole and the factors that led to the significant price increases for the latter.  In this case it seems like a lack of competition as being the limiting factor and the authors cite that "drug shortages, supply disruptions, and consolidations within the generic drug industry" are all factors that decrease competition and therefore may increase prices.  They also described the generic drug approval process as slowing down competition especially in a market where a delay in implementation of the generic can cost additional tens to hundreds of millions of dollars.

Both the NEJM article and the Chicago tribune article have a supply side emphasis.  Adequate competition and innovation in a free market increasing supply and driving prices lower while maintaining high value to the consumers.  But there is another story.  Demand for pharmaceuticals is relatively inelastic.  That means that if there are price increases buyers cannot postpone their purchases for a better day without the risk of significant and in some cases life-threatening consequences.  That inelasticity is compounded by several recent factors that lead the further complications.   The first is the advent of high deductible health insurance plans.  The majority of employers use these plans largely because managed care has failed to contain costs and costs to their employees are generally shifted to that risk pool in the subsequent year.  This puts anyone with high deductibles at significant risk for out-of-pocket costs until that deductible is satisfied.  Any drug manufacturer can expect to receive significant out-of-pocket payments while the deductible applies.  The second is the advent of "tiered' coverage based on the insurance plan.  This usually involves a steeper copay for an insurance plan that covers less.  The real risk is that the patient may decide to simply forgo the prescription, but until that point is reached there is a good chance that they will pay significantly more than the lowest generic price in the drug class.  The current system of government sanctioned managed care and inelastic pharmaceutical demand places all Americans at financial risk since it is essentially a tax and in many ways an entitlement to health care companies including generic drug manufacturers.

The other obvious factor that none of the authors comment on is that some pharmaceuticals remain top selling drugs despite the fact that they are now generics.  In some cases like Advair Diskus, the drug is in a unique delivery system that is also patented.  Anyone using Advair is very likely to want to continue to use this delivery system whether or not it is a generic drug or not and the price remains high.  In another example from asthma care, numerous metered dose inhalers underwent a regulatory change in propellants from chlorofluorcarbons (CFCs) to hydrofluoralkanes (HFAs).  That was accompanies by a patent and an immediate and significant price hike to anyone using these inhalers.

I think that this trend is instructive for a number of reasons.  First, it illustrates that when it come to pricing of any pharmaceutical product it is more complex than just monopoly power.   There are clearly market forces in play that will escalate the prices of drugs that have been around well past the patent expiration date.  Conversely, there are many medications that have no pricing power and to the concern of patients and physicians they are just no longer manufactured.  It is easy to understand why generic drug manufacturers are unwilling to maintain a large inventory just so Wal-Mart and Walgreens can have a $4 per month formulary.  Second, it shows that there is a potential for significant distortion of markets being introduced by managed care  companies and their government counterparts.  Rather than the idealized "cost effectiveness" some of the arrangements out there are anything but cost effective and my example of how saving pharmacy costs can explode the cost of care in another direction is a case in point.

Most significantly, we have gone through a period of blaming the name brand pharmaceutical industry (otherwise known as Big Pharma) for a number of problems.  They have been blamed inadequate disclosure of clinical trials data, distortion of clinical trials data, ghost writing articles for physicians, and misleading marketing practices.  Critics also have the usual complaints about efficacy and side effects but seem to miss the regulatory goal of getting a relatively safe and effective (but not perfect) drug into the market for use.  They seem to get a pass  on their influence at the FDA and in fact, some critics seem to think that they can create an idealized regulatory agency that is free from political influence.  These critics seem to suspend the reality that pharmaceutical companies are businesses and that the people on the science end of those businesses in all likelihood have no idea about what is going on at the business end.  The explicit motivation according to the critics is money - the fuel of all businesses.  The generic drug industry (Little Pharma?) has a much smaller marketing infrastructure.  Research and development costs are much less.   They aren't detailing physicians. Until recently they were viewed as the saviors of the patient with little resources and a definite positive for every managed care company looking to enhance their bottom line by lower pharmacy costs.  They were the antidote to Big Pharma.  Despite all of the positive spin there has been a 300% price increase in 5 years for generic drugs.  I don't think I am going too far out on a limb here to say that generic albendazole may be one of the most profitable medications ever made.  Politicians are starting to make noise.  Can physicians be implicated like they were in the Big Pharma scandals? I don't see how, but nothing coming out of Washington would surprise me.

But the real silence here seems to be all of the Big Pharma critics.  We have a generic drug industry with no real explanation for huge price increases at least nothing we can easily attribute it to.  Instead of saying that Big Pharma unconsciously influences physicians into prescribing their expensive drugs, we have hundreds of thousands of physicians consciously trying to prescribe the least expensive drugs for their patients and they are now failing to do that on a regular basis.  Maybe the appearance of conflict of interest isn't quite the theory it was cracked up to be?

Where are the Pharmascolds with their theories?    


George Dawson, MD, DFAPA

Refs:

1.  Ellen Jean Hirst.  Generic drug prices skyrocket in past year:  They were supposed top be cheaper but market forces have intervened.  Chicago Tribune  11, 30, 2014.

2.  Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs--implicationsfor patients and policymakers. N Engl J Med. 2014 Nov 13;371(20):1859-62. doi: 10.1056/NEJMp1408376. PubMed PMID: 25390739.

3.  National Drug Acquisition Costs.  Page with multiple files.  This is a large document with over 600 pages and 20,000 medications listed by NDC number.  For a sample click on the graphic below and discover why aripiprazole (Abilify) is such an expensive medication.

Life Is Not A Randomized Double Blind Controlled Clinical Trial

Or  what is wrong with placebo controlled clinical trials and transparency?

I was in an imaginary meeting with a bunch of Internists and Psychiatrists.  We were debating the available and meager literature on the use of trazodone for sleep.  We got into one of my favorite topics - the double blind placebo controlled trial and that catch all "Evidence based medicine."  The dialogue went something like this:

Internist:  "The evidence from double blind placebo controlled trials is weak for trazodone....."

Me:  "Do I need a double blind placebo controlled trial to tell me to prescribe trazodone for sleep?"

Internist: "Are you saying you don't need evidence.  Oh wait, I was at a conference where the head of the society stood up and and gave evidence that clinical trials have their limitations.  Like they are subsequently proven to not be true...."

Me:  "That is not what I am talking about.  I am talking about all of the hype out there that only 40% of people recover from antidepressants or that they are no better than placebo........"

Internist: "But you do have the algorithmic approaches that show...."

Me:  "Yada, yada, yada - for every algorithm, there is somebody with a meta-analysis to show it is wrong.  No I am talking about the ridiculous notion that psychiatrists could stay in business or want to stay in business if only 40% of the people they treat got better.  If that was true I would have become a recluse 20 years ago and just walked away."

General laughter

Internist: "I would kill for a 40% response rate for some of the problems that I treat."

And so on........

This informal conversation among colleagues is illustrative of the recent arguments that focus on physicians and generally psychiatrists more than other physicians that treatments are ineffective.  They are based on an oversimplified view of placebo controlled clinical trials and conflict of interest.  Many times there are no clear points of demarcation between what is a scientific issue (the technical aspects of the clinical trial) and the ethical issue (conflict of interest issues that may compromise the scientific results).   You can read all about current technical problems with clinical trials, like the common observation that there is a lack of generalizability to clinical populations compared with the highly selected and trial sample that in the case of psychiatry generally has much milder forms of the illness being studied.  Here are a few of the concerns that I don't see being discussed anywhere, especially when it comes to clinical trials of psychiatric interventions:

1.  The crude state of clinical trials:  Clinical trials in psychiatry are tremendously unsophisticated. The trial result generally depends on rating scale or clinician global rating scale results that grossly oversimplify the condition and measure parameters that are irrelevant in clinical settings.  The best example I can think of is depression rating scales that list DSM criteria for depression and then apply a Likert dimension to those symptoms.  In clinical practice it is common to see hundreds of patients with the same score on this scale who have a full spectrum of disability from absolutely none to totally disabled.  Which population might be more likely to exhibit an antidepressant effect?  It is also common to see medically ill patients with insomnia who may score as mildly to moderately depressed who are physically ill and not depressed at all.   The same problems exist with clinical trials of schizophrenia, anxiety and Alzheimer's disease.   When this weak technology is combined with a selection process that eliminates clinical populations with the most severe illness, it should not be surprising that any treatment being studied has a weak effect.

2.  A weak clinical trials data base:  One of the clarion calls of so-called evidence based medicine is the Cochrane Collaboration.  I have looked up hundreds of their reviews and the majority of those reviews of both medical and psychiatric studies is: "insufficient results and methodologically unsound".  I suppose it is good to have somebody make that statement, but if you have proclaimed that you are an evidence based physician - you have nothing to go on.  In fact, at some point you stop going to Cochrane because the results are fairly predictable.   Even in the case where you have a result does it apply to the patient you are seeing?  I don't see many Cochrane studies depressed patients that have right bundle branch block, ventricular premature contractions, or complex atrial fibrillation - all common patients seen in clinical practice.  How many more research papers do I have to read that conclude that "more research is needed" while continued inadequate trials are being published and analyzed by Cochrane?  From the current trends and political correctness of evidence based medicine this will go on forever.  The practical aspects are the very large costs of trials.  That is the real reason that pharmaceutical companies (Big Pharma) sponsor these trials.  The political system in the US has decided to farm out clinical trials to private for-profit companies in the exact manner that the US government has farmed out management of the entire health care system.  In these systems Big Pharma absorbs a disproportionate amount of criticism relative to managed care companies.  Managed care has equated "medically necessary" care with care that can be provided in the form of a pill.

3.  The politicalization of clinical trials:  No clinical trials of psychiatric medications can be done these days without an eye to the politically relevant dimensions.  A new antidepressant needs to get as many FDA approved indications as possible in order to beat the political restrictions of utilization review by managed care companies.   That would include indications not only for depression, anxiety, panic, and social anxiety but also chronic pain and possibly attention deficit-hyperactivity disorder (ADHD).  The best way to beat utilization review is to have the only FDA approved indication in the class.  That is also applied to atypical antipsychotics and that fact seems to escape the critics who focus on the number of prescriptions and what that implies.  Physicians are pawns in a game when there are no suitable tolerated medications for bipolar disorder depression and there are atypical antipsychotics for that indication.  These current political factors in clinical trials preclude a focus on cognition, functional capacity, and endophenotypes - all potentially much more valuable than a focus on diagnostic criteria or rating scales based on those criteria.

4.  A characterization that the average physician is ignorant - at best:  Any political movement is associated with ugly rhetoric.   There has clearly been an effort to stampede any physicians with reservations about evidence based medicine into a Neanderthal category.  The irony is that the criticism often comes from sources like managed care companies, medical certification authorities and the press (bloggers) - all entities with their own high levels of conflict of interest.  Common rhetoric used against psychiatrists has been: "You just don't want to be measured".  If the criticism originates from a government, managed care company or administrative authority there is often the attached explicit threat: "Those  days are over!".  The obvious implicit observation is that medicine and psychiatry is now being run by people who don't know anything at all about medicine and there is plenty of evidence on this blog to back that up.

Many critics seem to get a lot of mileage out of the position that they seem to be particularly anointed to criticize the field.   That seems especially true if they happen to be a physician as in: "My colleagues certainly seem to be a bunch of chumps and therfore can be rejected on a wholesale basis or of course listen to me for enlightenment".  I have never witnessed that level of incompetence in any group of physicians where I have practiced across multiple settings.

5.  The use of statistics for rhetorical purposes:  At this stage after reading research for that past 35 years, I am convinced that you can come up with a meta-analysis that will show whatever you want it to show.  Several years ago in the New England Journal of Medicine there was a study that looked at how well meta-analyses predict the results of available large scale clinical trials.  That study showed 2/3 times.  It is common to see a result and then see a meta-analysis that "disproves" the clinical trials result.  Nobody seems very interested in looking in detail at how sound that meta-analysis was.

Today we have a large number of questionably valuable clinical indicators or quality care markers that are often based on the political rhetoric of the government and managed care organizations.   They may be invalid on the face of it, but there is a second equally important aspect.   These same organizations have no valid approach to looking at the statistics of longitudinal data.  They will look at clinic results or even results from the same physician and convert them all to a numerator and a denominator.  Whether that fraction means anything or not is anybody's guess, but there is an administrator somewhere who will be happy to tell you all about it.

6.  False assumptions about the expertise of physicians:  Much of the rhetoric above is focused on physicians.   Psychiatrists as the most politically disenfranchised group are a frequent target.  In the past years we have endured the ideas that medical treatments being prescribed are ineffective and overprescribed.  That brings us full circle to the opening imaginary conversation.  Physicians are trained to focus on several goals including acute treatment, treatment of chronic problems, and providing care for the dying.  The psychiatrists and physicians that I have had the pleasure of working with have been highly effective is achieving those goals.  When I look at the modest results of poorly designed clinical trials all I can do is shake my head.  I would have quit a long time ago if my diagnostic or treatment capabilities were accurately described in clinical trials and most physicians would have.  Informed clinical treatment is a series of often rapid changes in course, rejecting poorly tolerated treatments and looking for things that work better along the way.  I can change the course of treatment depicted in a clinical trial in one day.  In the trial that result is carried to the end as a failure.  How is it that a clinical trial or this evidence would predict my treatment results by mean?  If a treatment is ineffective or not tolerated in my practice, I don't stop treatment and call that person an unsuccessful intent-to-treat subject.  I work with them to establish effective treatment - often in the same time frame as a clinical trial.  Is it quite literally absurd to suggest that clinical trials accurately describe what will happen in clinical practice and yet that is the state of discourse.

7.  The false promise of transparency:  Anyone who followed politics knows that disclosing potential conflicts of interest  is meaningless in the case of politicians.  The general idea is that politicians would refrain from either accepting money from sources where they are involved politically or just not be involved in that area of legislation.  In reality that does not happen.  Sometimes the politicians involved will speak out against any suggestion that there is a connection between the money they receive and their legislative record even when their activities are consistent with a financial conflict of interest.  The sunlight of transparency that many of the critics talk about simply legitimizes ongoing involvement in areas of potential conflict of interest.   Disclosure is a stamp of approval for involvement.  All of that can be researched on Congressional watchdog sites.   The new CMS web site that posts payments to doctors is hyped as a way to appease all of the critics who seem clueless about transparency.  For an eye opener take a look at their decision point on conflict of interest.  CMS seems much more charitable than the typical blogger, politician or journalist with this disclaimer:

"Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper.  Just because there are financial ties doesn’t mean that anyone is doing anything wrong.  Transparency will shed light on the nature and extent of these financial relationships and will hopefully discourage the development of inappropriate relationships.  Given the complexity of disclosure and the importance of discouraging inappropriate relationships without harming beneficial ones, CMS has worked closely with stakeholders to better understand the current scope of the interactions between physicians, teaching hospitals, and industry manufacturers."

8.  A lack of appreciation of the regulatory environment:  In the rush to condemn Big Pharma and anyone associated with them, critics often have an idealized version of regulation in their minds.  If only they had access to all of the clinical trials data to analyze for themselves.  They would personally be able to hold Big Pharma's feet to the fire and only allow drugs to be approved that they deemed to be safe and effective.   They are smarter and more ethical than anyone doing the actual trials and certainly smarter than the regulators.  This is at the minimum a failure to recognize that pharmaceutical regulation is after all a political process.  Like all politically directed regulation there are broad goals of safety and efficacy but they are relative and the regulatory mandate takes that into account.  On this blog I have pointed out several cases of medications that not only I,  but the Scientific Committee employed by the FDA recommended against based on safety considerations, but that were approved by the FDA.   Many drugs that I approved as a member of a Pharmacy and Therapeutics Committee (P&T) were expensive but had minimal efficacy.  We approved it based on political considerations (small but vocal advocacy group and untreatable illness) rather than pure efficacy or safety considerations.  The regulatory environment is currently designed to get promising agents into the hands of clinicians for clinical use.  The limited exposure of patients in clinical trials means that rare but serious side effects will not be recognized until post marketing surveillance occurs.  Every person taking an FDA approved medication should realize that.  The regulatory process is not designed to provide perfect medications because there are none.

There is a lot more to say about this subject like a detailed analysis of how the politicalized version about how physicians work and think has nothing to do with the way physicians actually work and think.  But for today I am stopping here.

Life is not a randomized double blind controlled clinical trial and that is generally a good thing.

George Dawson, MD, DFAPA

Alkermes And The Pharmaceutical Company Dynamic

I was reading this month's Journal of Clinical Psychiatry and came across a dimension of the psychiatrist - pharmaceutical company  dynamic that is rarely the object of analysis.  I can't put the ad here because it appears to be copyrighted so I will have to describe it and you can see the graphic here.  There is a picture of a man in a brown pullover sweater in the middle.  His hands are pressed together and he has a concerned look as he looks toward a younger man who is slightly unkempt to his right.  The younger man is staring away and making no eye contact.  To the far left behind a counter is a woman wearing a white coat and protective gloves as she swirls an Erlenmeyer flask containing bluish liquid.  My theory of the mind says the man in the middle is a psychiatrist, the man to his right is the patient and the woman is some kind of biomedical researcher.  The copy reads:

"Your challenges are our challenges.  At Alkermes, we're inspired by the challenges that psychiatrists face every day.  We share your dedication to patients living with schizophrenia, depression or addiction.  So when we develop new treatments, we begin with a compassionate understanding of your real world needs.  We stand ready to improve the health of your patients."

I am sure that most psychiatrists can see this for what it is - advertising and would have suggested that Alkermes take a less melodramatic approach.  Alkermes is relatively new to CNS pharmaceuticals but it has drugs in the pipeline for both schizophrenia and depression.  Many addiction psychiatrists are used to seeing their version of long acting naltrexone called Vivitrol.  I have never seen a sales representative from the company.  Pharmaceutical company reps have taken a hit with the new anti-Pharma religion and they are banned from most clinics, hospitals, and academic settings in my area.  The rap against them has been that they were essentially influencing physicians to prescribe their products by financial incentives in the form of gifts or in many cases personal relationships, or a combination of both.  A secondary issue was that some of the Pharma associated educational activities were more or less well disguised advertising in a number of forms.

This new approach by Alkermes taps into an area with psychiatrists that I have not previously seen as an area of focus.  It is basically saying to the most beleaguered physicians: "We understand what you are up against and we are on your side."  Although it seems like a clumsy first attempt, the message is powerful.  If you are a senior psychiatrist and have practiced as long as I have - you realize that apart from any good colleagues that you might have from time to time - there is nobody on your side.  Many psychiatrists are professionally isolated and may see their colleagues at an annual meeting.  Others in larger organizations are mismanaged to the point where their colleagues are seen as competition rather than resources.  There is nobody on your side professionally or in your attempts to treat your patients.  In fact as I have illustrated here, there are many people in your way when you try to provide care to patients.  They are incentivized to get you to ration care and in many cases that comes down to providing no care.

The Alkermes approach captures at least a part of the unconscious reason for affiliating oneself with a friendly entity.  My guess is whoever is behind it does have an understanding of what is going on with physicians and psychiatrists in particular.  A pharmaceutical company ad will never make it explicit,  but there is also an asymmetry in the relationship they are  discussing.  Bundling the cost into a pharmaceutical product is a much more effective way to get reimbursed than bundling cost in the form of a psychiatrist.

Even though they appear to feel our pain - they don't really have to.

George Dawson, MD, DFAPA



Supplementary 1:  Breaking news from the U.S. Patent office:

Aripiprazole lauroxil: patent app 13/607,066 covers methods of treating schizophrenia, mania, bipolar disorder, anxiety or depression by administering a broad class of compounds including aripiprazole lauroxil.

ALKS 5461: patent app 13/715,198 covers composition of matter.

ALKS 3831: patent app 13/215,718 covers the attenuation of weight gain associated with olanzapine in patients with schizophrenia by administering the combination of samidorphan (formerly ALKS 33) and olanzapine.

ALKS 7106: patent app 14/169,305 covers composition of matter.

For full details read the press release from the Alkermes web site.

Era of Blockbusters Is Over? I Hope So.

1BOM posted a link to a Forbes article on the issue of blockbuster drugs.  Journalists are typically slow to pick up on this because it takes the element of scandal out of any relationship between physicians and the pharmaceutical industry.  After all, aren't physicians clueless about pharmaceutical advertising and mindless cogs in Big Pharma's attempts at hegemony?  The tone of the article is that Big Pharma is now increasing the drug prices for therapies targeting fewer conditions.  No thanks to Big Pharma for all of the innovation currently used by the generic pharmaceutical companies.  As an example, I bought a bottle of montelukast (90 tablets) a month ago for $9.  It is the Singulair product list as Merck's 2010 blockbuster drug in the Forbes article.  As far as I can tell, it is the only effective treatment for an asthma attack that has caused me to take oral prednisone, inhaled glucocorticoids of various types, nebulizer treatments, inhaled ipratropium, and various inhaled beta agonists for the past four months.  I didn't see the US government or the academic community inventing montelukast.  In fact, I don't see the US government or the academic community doing much about the fact that the average asthmatic is still wheezing and there is no effective approach to preventing the spread of respiratory viruses that are a major cause of this problem.  I guess their solution is to partner with managed care and suggest that pay-for-performance is going to save us all.  Maximum treatment with everything except montelukast has done nothing for me.  What would pay-for-performance do?

Maybe that is why doctors who I have seen always ask:  "Are you sure you NEVER have smoked?" That seems to happen after the usual: "I like to treat asthmatics because I can do so much for them!"  If that is true why are most asthmatics still wheezing?  I think it is fair to say that the only reason I am wheezing less at this point is due to Merck.  The necessary CME disclosure at this point is that I do not own any pharmaceutical company stock, but I am quite willing to admit it when I see a good product defined as one that works for me.  Since the focus of this blog is on psychiatry - I also get direct feedback from patients that the medication I prescribe has had some of the same effects.  That is even in the case of medications that I never prescribe - paroxetine and fluoxetine, in people I see for consultation.  And for all of the clinical trials obsessed out there - I suppose I could just say or think: "I guess this person is unfamiliar with the meta-analyses critical of antidepressant efficacy." or at least: "I guess this person has never been on the Internet and read about the horrendous side effects of these medications."  But being the foolish psychiatrist I am, I am likely to think that a person with severe depression requiring hospitalization, severe postpartum depressions with psychosis and suicide attempts, or severe disabling depression may have actually found an effective medication that works for them.  I am much less impressed by the work of statisticians than the experience of my patients, especially when their lives are back on track.

In terms of the cost of psychiatric medications, this is really an old issue.  It was years ago when I noticed that people could pick up citalopram for $4 a month at Wal-Mart.  I had to point the wide availability of generic antidepressants in a response to a Washington Post article.  I guess the DSM-5/Big Pharma conspiracy is not looking too good now.   Sure there are new antidepressants, but there is no reason why they should be first line drugs.  Anyone with an first time PHQ-9 elevation is going to get an inexpensive SSRI.

All of the critics of Big Pharma were naturally slow to pick up on it, especially the antipsychiatry crowd because it means that the moral high ground is lost.  They can no longer devalue everything that psychiatrists do based on the alleged Big Pharma connection with a handful of psychiatrists.  Of course they can keep the conspiracy theories going about some missing clinical trial results of a now generic drug that is over thirty years old.  They can conflate that as having something to do with psychiatry despite the fact that the major regulators like the FDA have done nothing about the drug based on post marketing surveillance.  They  can blame psychiatry for the overprescribing of primary care physicians and the institutionalized overprescribing of managed care systems.  The antipsychiatrists will certainly continue to hate psychiatry and the critics will still have an axe to grind with particular psychiatrists. But at least I won't have to tolerate a smug blogger proclaiming that they were "Keeping psychiatry honest since 2007."  I have actually done very well maintaining my honesty without the help of a self promoting blog and the psychiatrists I know have done the same.

And wait a minute - what about the real epidemic that has been actually killing more than 10,000 people per year for over a decade?  Plenty of generics there and plenty of ways to take way too much acetaminophen.

The other problem with the Big Pharma conspiracy theories has been a general naivete about capitalism and marketing.  Advertising is good for the New York Times, but not a medical journal or meeting.  Physicians need to be cloistered from market influences.  They could be corrupted in a way that is inimical to the interests of patients.  Direct advertising of toxic medication to consumers is a much preferred route.  As far as the "me too drug" argument goes, let me illustrate the problem with that argument by my trip to the convenience store today.  I ran out of grape juice today.  I only drink Welch's 100% grape juice, diluted at a ratio of about 5:1 with carbonated water.  I drink about 576 fluid ounces of the stuff per month.  Rather than go to a supermarket, I went to a convenience store because it was closer.  On the shelf were a vast array of chemical drinks and sodas of no nutritional value, small bottles priced at what I could buy 64 ounces of pure unsweetened grape juice for.  The comparisons were overwhelming.  Self proclaimed nutritional drinks that had no calories, no protein, and plenty of artificial sweeteners.  Natural juice "beverages" or "cocktails" that had vanishingly low amounts of actual juice.  All of these products basically knock offs of fruit juice, but, heavily marketed, neatly packaged, much more expensive, and having the occasional nutrient value of added vitamins.   Does a "me too" pharmaceutical have less value than a "me too" soft drink?  There is no comparison.

I also had the association to my Peace Corps experience.  In the country where I served in Africa, there was a place called the Northern Frontier Zone.  There was a police outpost there and you had to sign a register acknowledging that the local government was not responsible for your safety once you crossed into that territory.  One of the best ways to get there was to hitchhike on large trucks carrying Coca-Cola.  You just had to get comfortable laying on cases of Coke.  Over the years,  I have drank as much Coke as anybody - but for the purposes of this post and the focus on advertising and marketing consider what I am saying here.  In 1975, Coke was widely available in remote African villages and the Northern Frontier zone.  For most people it was more widely available than clean water.  Since then. they have sold increasing amounts of the product.  The world is dominated by American cola manufacturers.  Are "me too" pharmaceutical products less valuable than Coca-Cola?  I would suggest that they are probably not and they are marketed a lot less vigorously.  Unless I have missed it there has been no complaint about Coke's world domination, although I sincerely hope that a psychiatrist is never photographed drinking a can.

I might be biased by a good four months of decreased wheezing, but I hope the general message on the Forbes article gets out and clears some of the air.  In psychiatry, there are many more important things to focus on than conspiracy theories that really don't apply to the vast majority of psychiatrists.  You can't take physicians out of their historical mandarin role and instead blame them for colluding with Big Pharma.  It may have been a political strategy to get them out of that role and suggest that politicians (of all people) should assume that role.

The work psychiatrists do is tough and demanding.  No psychiatrist who I have ever talked with expects a pat on the back.

Getting out of our face is a pretty modest wish.

George Dawson, MD, DFAPA

Supplementary 1:  I also have no financial interest in any of the other products mentioned here including Welch's grape juice or Coca-Cola.  I used the real names because they are historically accurate.