Beware a new/old pharmaceutical trend of which this is an egregious example! “Eli Lilly and Co. on Monday said it has won regulatory approval to sell its new drug Symbyax to treat the depressive phase of bipolar disorder.
The U.S. Food and Drug Administration approved the drug, which is a combination of the active ingredients in two other drugs _ the anti-depressant Prozac and the anti-psychotic Zyprexa, which is used for treating manic stages of bipolar disorder.” —Dallas-Ft Worth Star-Telegram
I have difficulty with referring to this as a ‘drug’, or referring to ‘the anti-depressant Prozac and the anti-psychotic Zyprexa’ as ‘drugs’. These are products; the ‘drugs’ or ‘medications’ are the ‘active ingredients’. I refuse to prescribe products, writing all my prescriptions by the generic names, i.e. the ‘active ingredients’, instead, and challenging all the nurses who take off my orders in the hospital to learn the generic names. (It is sort of like refusing to wear teeshirts that make me a walking billboard for a product name…) It may seem a foolish conceit or a merely semantic difference but it is a polemical point upon which I insist. In a case such as this, it clarifies the thinking and helps one see readily that there is no ‘new drug for bipolar disorder’ here, really just a new product which combines several existing drugs.
A generation ago in psychopharmacology, we got rid of such ‘fixed-dose combinations’, which have several problems. The obvious one is that I can already prescribe the two pertinent medications independently and in combination for the patient, and have much greater control over the two dosages independently. The only downside of the latter approach is that the patient will have to swallow twice the number of pills, or thereabouts, as in the new product. But I have rarely seen a patient in whom the advantages of that outweigh the disadvantages of the fixed-dose combination, although the drug company will try to sell the product to doctors by appealing to its convenience to their patients. If you grant me that there is no medical advantage to the fixed-dose combination, then it becomes clear that it is for drug company profit alone. For one thing, if they succeed in pushing this product, they retain the right to sell the ‘new drug’ at a high price even as generic versions of its constituent medications become available. Generic fluoxetine for far less than Prozac brand is already here, and in several years olanzapine will be off-patent and available for far less than Zyprexa brand as well. Furthermore, if I am a devotee of this product, whenever my patient on Lilly’s antipsychotic Zyprexa requires an antidepressant, I would be sure to be giving Lilly’s antidepressant, Prozac, rather than a competing and possibly superior one. Finally, the drug company hopes that some doctors will, carelessly, give in to the temptation to give the two-component medication to patients for whom one of the two alone would suffice, i.e. patients will receive an antipsychotic medication and an antidepressant together even if they are nonpsychotically depressed, or nondepressively psychotic. This will double the drug company’s profit on such patients in one fell swoop.
There is already a problem of ‘polypharmacy’ in modern psychopharmacology; I see patients, especially the chronically mentally ill whom I specialize in treating, arrive at the hospital with appallingly long lists of medications they are prescribed. Drugs are added readily for new twists or turns in their disease presentation, but rarely are others reduced or eliminated. Little thought is given to what might or might not be working. It is no wonder these patients cannot or will not comply with their medication regimens, given the bewildering complexity of their daily dosing schedules and the unmanageable side effects their medication combinations may be causing. Imagine how much more problematic this will become when, at every swipe of the pen, their doctors can add two new medications to their list!
If you are interested in the psychopharmacological treatment of bipolar disorder, there are several further problems with this product in particular, over and above my generic objections to ‘fixed-dose combinations’. The fluoxetine (antidepressant) component to this product may be largely unnecessary to begin with. Many psychiatrists feel that one of the advantages of the newer, so-called ‘atypical’, antipsychotic medications such as olanzapine (Zyprexa) is concomitant mood-stabilizing and antidepressant activity as well as the antipsychotic efficacy. If you read the article, you will see claims that this product may begin to work more rapidly than less novel approaches. Although I have heard this claim accompanying the introduction of every new psychopharmaceutical during my twenty-year career (and it never turns out to be borne out in practice; the drug companies’ marketing departments just know how to play on the heartstrings of those of us who have to wait for the onset of action of the medications we give to people while they are in agonizing distress), if it has any merit in this case it may be because most patients for whom it has been prescribed will heretofore have been on Zyprexa or another atypical antipsychotic and, as I stated above, therefore may have gotten a headstart on antidepressatn effects as well.
Furthermore, a bipolar or manic depressive patient can only benefit from an antidepressant during their (time-limited) depressive episodes. It is actually dangerous to keep them on an antidepressant when they are nondepressed, because the antidepressant can drive them to the other extreme, a manic ‘high’ (with eiher euphoria and self-destructive boundless energy and drive, or dramatic hyperirritability and ultimately psychosis). A physician who follows path-of-least-resistance prescribing may also be one who does not get around to changing the patient back from Symbyax to plain vanilla Zyprexa rapidly enough when they come out of their depressive phase. Bye bye mood stability…
So: if you or your loved one are prescribed a new medication (oops! product), be sure to ask the prescriber (a) if it is a ‘fixed-dose combination’; (b) if it is, whether both the medications are really necessary, or if one might suffice; and (c) why the two cannot be prescribed as separate pills rather than together.
By the way, I have previously noted the loony appeal of all the ‘q’s, ‘x’s, ‘y’s, and ‘z’s in the names of the newest psychopharmaceuticals. There is scarcely one without, especially among the most-recently developed antidepressant products: Prozac, Desyrel, Zoloft, Paxil, Luvox, Serzone, Celexa, Lexapro, Effexor and Zyban; now Symbyax. In the last fifteen years or so, only Remeron fails to meet the bill. Three of the six most-recently introduced antipsychotic products are: Clozaril, Zyprexa, and Seroquel. The product-naming consultants the industry uses show this brain-dead lack of creativity in their long-hackneyed approach, but they still, as far as I have heard, make enormous consulting fees for each of these crazy names. This xenophilic trend tends to strengthen the esoteric and occult flavor of the physician’s role and the inaccessibility of her knowledge to the layperson, I imagine.