Psychiatry, Drug Costs, and Generics

Psychiatry, Drug Costs, and Generics

Several days ago, I asked several questions about the subject of the title above. I was hoping for more response than I received. One note I received from someone who works for one of the generic pharmaceutical makers in the patent area seems to mostly fit with what makes logical sense and what I can find with some searching, and somewhat fits with the complaints that I am hearing from people working in the mental health field. Since she works for a generic drug maker, she doesn't have any financial interest in making the non-generic drug companies look good.

Concerning the first question: are there financial arrangements that would encourage psychiatrists to prescribe the newest and most expensive drugs instead of the generics? Her answers (slightly edited here and there):

On question 1, if there are monetary payments, the doc and drug company can get into serious legal trouble, big time, not only ethically but with FDA and Medicaid/Medicare fraud claims.

Okay, this is about what I would expect. I did find this 2004 USA Today article indicating that such kickbacks are indeed, unlawful. The federal government prosecuted a number of employees of TAP Pharmaceuticals who it claimed (and a former VP of the company claimed) "offered kickbacks to doctors in the form of consulting fees, dinners, golf trips and other favors to get them to prescribe certain drugs." The defendants were found innocent, but it seems utterly clear that such kickbacks are unlawful.

That doesn't mean that it can't happen, of course. But it does mean that if it is happening, it either has to involve a lot of cash payments to doctors, and a lot of income tax evasion, or more likely, it isn't the norm.

That said, drug companies obviously spend a large amount of money on sales forces because there are a lot of drugs that are responsive to marketing. In other words, if a doctor's office has had 3 visits a month from a sales rep discussing X drug, that drug is simply going to have more visibility/recall to that doctor compared to a doctor who only got 1 visit a year, and subtle shifts in prescribing will in fact occur as a result.

This, sad to say, may well explain the complaints that I am hearing. Marketing works. It works for consumer products (unless really poorly done). It works with product placement in movies. I find it easy to believe that effective marketing is causing psychiatrists to prescribe the most recent and most expensive medications, unless someone actively reminds them, "This patient has no insurance."

Brand companies also usually try to find some particular niche where they can distinguish their product from an existing one on the market, i.e., superior effect in Z patient population, reduced side effects, etc. Brand companies also look early on for doctors considered to be "key opinion leaders" who can speak at conferences and write papers and discuss the drug in a positive way.

This is a potentially worrisome problem. This article from the April 29, 2009 Milwaukee Journal-Sentinel describes how Dr. James Stein, "an up-and-coming heart doctor, was ripe to be hooked as a drug company speaker." The danger isn't that large numbers of rank and file doctors are going to be corrupted by this, but that prominent doctors may, by arguing for the advantages of a new proprietary drug, persuade other doctors that they should prescribe this, rather than the cheaper generics.

A practice with an in-house pharmacy may be getting significant discounts/engaging in markups on various drugs that they stock, or get "bonus" points if they have a large volume of Brand Q drugs getting sold, and in that way might be able to get some marginal income benefit. Are there doctors who are more likely to prescribe a drug if a cute sales rep is giving him the hard sell? Sure. Does advertising work? Unquestionably, even if the doc swears that he is not influenced by it. And brands are also going to be more willing to give out free samples if a doc is prescribing their drug often; this can actually work to the benefit of indigent patients who might not be able to afford the drug otherwise. But most doctors I've encountered would always put their patient's needs first, and won't prescribe something sub-standard to get a few extra bucks from the pharma company.

I think this is probably the case--not that psychiatrists are intentionally prescribing only the newest and most expensive drugs, but that they aren't thinking about the costs. I suspect that a lot of doctors don't think about the fact that the generic medication X may cost $4 at Wal-Mart--while the newer and perhaps better proprietary medication Y is going to cost $190. Y may be more effective, or have less side effects than X--but if the patient can't afford Y and luxuries like food and shelter, it might be better to prescribe X.

On the question of whether the newer medications are really more effective or less prone to side effects than the older, now generic medications for mental illness:

On question 2, safety and efficacy are always the things doctors care about most; they are what FDA cares about most; and thus brand pharma cares about it most, because if it isn't in a published peer-reviewed journal or in their FDA-approved labeling, they (in theory) can't market it for that purpose, and if they can't market and differentiate it from a competitor, no market share.

With the antidepressant drugs, at least, because there are so many different approaches to tackle the problem, and because so much more is being learned about the nuances of who responds to what, what receptor effects what, and even then a lot of individual therapy remains trial-and-error (someone may see no benefit to paroxetine or fluoxetine, and do great on Wellbutrin or an MAO inhibitor; someone may have nasty side effects on depakote but few on lithium), there is a lot of commercial value in being able to say your drug is more targeted, fewer side effects. The other big thing is dosing regimen (i.e., a patch, once-daily dosing). Also, for people who may have many pills to swallow in a given day, combo products, or enhancing bioavailability so that you are taking smaller amount of drug (in a smaller pill or capsule) to get the same therapeutic effect can have some benefit as well.

It is not unreasonable to expect that 3rd generation drugs will, on aggregate, be better than 1st generation drugs, on aggregate. FDA will usually want you to do your clinicals against one of the better standard-of-care drugs, not one of the older drugs, so if you can make a claim of superiority compared to a newer drug, you are likely even better than the older drug. That said, it doesn't necessarily follow that in a particular individual case, a newer drug will work better than an older drug. (Also, on antidepressant drugs in particular, one should always be cautious about switching from ANY brand or generic to another brand or generic. Even if you have three different generic companies and 2 brand companies with tablets that contain identical drug doses, there is always going to be a very tiny portion of the population (emphasis - we're talking about in the statistical noise, usually) that will be somewhat effected by the particular formulation at issue and thus may effectively get a different response on different formulations than the average Joe would.)

This book Out Of Its Mind that I am reading (as well as a number of others that I have for my research on my next book) seem to accept that the newest antipsychotic drugs are markedly better than the older generics. Of course, this still comes back to the horrifying problem: if Y works better than X--but your patient can't afford Y--maybe you should be prescribing X.

My third question was about the peculiar situation of psychiatrists prescribing the same medicine for many diffferent mental problems:

On 3, I suppose it depends on where the psychiatrist is drawing his patient population from. But if one doc is using the same drug over and over again, since doctors are very much creatures of habit and litigation-averse, if they have had a good experience with a drug before, it wouldn't surprise me that they are more likely to use it again and again before trying something else unless the data for the other drug is really compelling in a given situation.

Also, never fail to ignore the possibility that patients themselves are asking for it. Anytime a drug company gets a new FDA indication, for example, they do a big marketing blitz, and there will be a spike in the number of patients telling their doc that they want X drug for their problems. If you are a doctor and know that all of the drugs work about the same, and your patient demands brand X, you're going to prescribe brand X. (This is happening a lot with the bisphosphonate drugs, for example. Women see Sally Field on TV saying Boniva stopped her osteoporosis, and see the corresponding print ads in the women's mags, and when their doc tells them that their bone density is decreasing they ask for Boniva because that is what they know, even though risedronate, alendronate, zoldronate, etc. each work as well, and each drug has similar side effect profiles, and some are generic and others are not.)

I confess that the circumstances that I am hearing complaints about don't seem to fit this very well. Hobson and Leonard's Out Of Its Mind paints a portrait of psychiatry as a profession that went from wasting huge amounts of time and money on useless psychoanalysis, to a profession that is largely prescribing pills. One might get the impression from their portrayal that the profession has lost heart, and has becomes something of a machine, grinding through patients.