FDA approves drug for bipolar disorder

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.

Worried Pain Doctors Decry Prosecutions

Ascroft’s hounds of hell are demonstrating that they are unable to tell the difference between a racketeering conspiracy and legitimate medical practice, in the cases of several high-profile prosecutions of pain specialists for their volume of narcotics prescribing. The established medical use of opiates is, some doctors say, becoming criminalized, while Ashcroft crows about “our commitment to bring to justice all those who traffic in this very dangerous drug” (OxyContin). Obviously, Ashcroft has never suffered from one of the debilitating chronic pain conditions for which OxyContin and similar medication advances have been the only solution, and has no compunctions about throwing babies out with bathwater.

While there are certainly mendacious physicians who run “prescription mills” for quick profit, writing painkiller ‘scripts for all comers regardless of medical need, it seems these prosecutions are capturing mainly those unfortunate doctors whose only crime may have been choosing to specialize in a field of medicine, pain management, that makes them conspicuous to our ever-vigilant law enforcement bulldogs. Their names will appear on the radar screens simply due to the volume of ‘scripts they issue and the almost inevitable likelihood that, somewhere along the line, someone will divert some of their OxyContin to the extremely lucrative street trade. There are no certainties in managing pain, and doctors are at different points along the continuum of attention to (or paranoia about?) issues of diversion and addiction. While I am not a pain specialist and shy away from prescribing narcotics de novo, I certainly often maintain a narcotics-dependent patient on their preexisting prescriptions when they come into the hospital with psychiatric problems (which, as you realize, I’m sure, may be difficult to disentangle from substance-abuse difficulties). I do interpret my mandate to first do no harm to include not facilitating narcotics abuse and addiction, but I remind myself that I am not omniscient and, despite my skills, will be deceived from time to time as to the legitimacy of the pain complaints of a patient. I console myself with the reminder that these patients are primarily fooling themselves. I don’t take it personally, but then again I do not have Ashcroft’s thugs breathing down my neck either.

[It bears pointing out, in my continuing tirade about the irresponsibility of the pharmaceutical industry, that OxyContin could have been formulated in a manner that would prevent the pils from being processed for street users to shoot up, as is the case with other sustained-release narcotics preparations which are not diverted in a similar manner.]

Have an Inoffensive Holiday Season

A reader posted this to Dave Farber’s IP mailing list:

I wanted to send out some sort of holiday greeting to my friends, but it is

so difficult in today’s world to know exactly what to say without offending

someone. So I met with my attorney today, and on his advice (and after $299

in attorneys fees) I wish to say the following:


Please accept with no obligation, implied or implicit, my best wishes for an

environmentally conscious, socially responsible, low stress, nonaddictive

gender neutral, celebration of the winter solstice holiday, practiced within

the most enjoyable traditions of the religious persuasion of your choice, or

secular practices of your choice, with respect for the religious/secular

persuasions and/or traditions of others, or their choice not to practice

religious or secular traditions at all.


I also wish you a fiscally successful, personally fulfilling, and medically

uncomplicated recognition of the onset of the generally accepted calendar

year 2004, but not without due respect for the calendars of choice of other

cultures whose contributions to society have helped make America great (not

to imply that America is necessarily greater than any other country or is

the only “AMERICA” in the western hemisphere), and without regard to the

race, creed, color, age, physical ability, religious faith, or sexual

preference of the wishes.


By accepting this greeting, you are accepting these terms: This greeting is

subject to clarification or withdrawal. It is freely transferable with no

alteration to the original greeting. It implies no promise by the wisher to

actually implement any of the wishes for her/himself or others, and is void

where prohibited by law, and is revocable at the sole discretion of the

wisher. This wish is warranted to perform as expected within the usual

application of good tidings for a period of one year, or until the issuance

of a subsequent holiday greeting, whichever comes first, and warranty is

limited to replacement of this wish or issuance of a new wish at the sole

discretion of the wisher…


Disclaimer:


No trees were harmed in the sending of this message, however, a significant

number of electrons were inconvenienced.

Annus horribilis

Here is how the Guardian sums up 2003 (this is a review of its year-end summary book):

“Of course Iraq is central, sickeningly portrayed by Suzanne Goldenberg’s ‘Picture of Killing’ and Audrey Gillan’s ‘Death by Friendly Fire’ – though there’s too little about the aftermath or about Hutton’s inquiry into how we were duped.

But other themes flood in – Hamas’s ‘total war’ (omitting that it is because the Middle East peace map has been distorted by Sharon into a road to nowhere), and Sarah Boseley’s heart-rending picture of a soon-to-die mother in Malawi, illustrating the fate of 29 million people with Aids in sub-Saharan Africa.

Martin Kettle assesses the neocon hard-right assault on US affirmative action and pro-diversity laws. Raekha Prasad denounces the UN ‘protection areas’ for refugees that enable Britain to deport more asylum-seekers. Polly Toynbee dissects the growing trade of female trafficking, a modern variant of the slave transportation of past centuries, with 2 million women trafficked each year – a less remarked-on aspect of globalisation. Martin Jacques chronicles the jeering and booing at the Williams sisters and their father in middle-class, lily-white tennis. Racism is never far beneath the surface, and the accentuation of inequality in 2003 has served only to make it more pronounced.

The American imperium, with its unalloyed unilateralism, entered this year in full spate, and leaves it in deep disarray. But its workings are a great deal subtler and more pervasive than merely enforcing regime change. Ian Traynor recounts the brute diplomacy to secure war crimes immunity deals for Americans and the exercise of the aid card to bring vulnerable countries into compliance with US demands for exemption from the international criminal court. And George Monbiot admirably captures the new messianic order: America is not so much a project as a religion. It’s not just that Americans are God’s chosen people; America now perceives itself as on a divine mission for the liberation of mankind.”

The reviewer, a former MP, notes some omissions, however:

t would have been nice, but not essential, to have had an angle on the rise and rise of the corporate state, the first clear signs of the coming oil crunch, the collapse of party democracy, the plague of obesity, the neglect of global warming as the greatest threat to the planet, and the rebellion against spin … But you can’t have everything.

“…but not essential…”??

Mad Cow Disease

The killer illness for a new world order, a 2001 Slate piece by David Plotz, written in response to the European BSE scare and now resurrected in the face of the current spectre of American panic:

“Mad cow fits the classic profile of a disease likely to cause hysteria. Ebola, AIDS, and polio—three of the most flamboyant illnesses of the century—overshadowed deadlier but less flashy plagues, such as malaria, for several reasons. First, the hysteria-inducing illnesses usually affect young people and strike in particularly gruesome ways. Ebola causes massive bleeding from every orifice. AIDS is responsible for grotesque cancers and infections. Polio paralyzed young children.


Second, at the moment of the panic—before much is learned about the disease’s origin—everyone seems vulnerable, and it’s not clear that prevention is possible. Maybe an Ebola victim flew in from the Congo and breathed on you! Maybe your dentist is HIV-positive! And finally, the disease organism is new and weird and seems to have sprung from a dark, mysterious place. AIDS is a creepy mutating monkey virus. Ebola remains a riddle: The Hot Zone traces it to the bats in a spooky East African cave.


Mad cow is similarly vicious, unstoppable, and mysterious. It murders by driving its young victims insane, then melting their brains. It theoretically puts anyone who ever ate English beef at risk. It was spawned in the miasma of rendering plants and slaughterhouses, our own hell’s kitchens. And the disease organism is a mystery.”

Righting the Ship of Democracy

Presenting Deliberation Day: A radical proposal to help voters make better decisions, write Bruce Ackerman, Sterling Professor of Law and Political Science at Yale University, and James Fishkin, Janet M. Peck Chair in International Communication and Director of the Center for Deliberative Democracy at Stanford University.

“In our soon-to-be-released book, we offer a new way of thinking about democratic reform, proposing a new national holiday—Deliberation Day. It would replace Presidents’ Day, which does no service to the memories of Washington and Lincoln, and would be held two weeks before major national elections.

Registered voters would be called together in neighborhood meeting places, in small groups of 15 and larger groups of 500, to discuss the central issues raised by the campaign. Each deliberator would be paid $150 for the day’s work of citizenship. To allow the business of the world to carry on and as many as possible to participate, the holiday would be a two-day affair.”

They note that, while sustained public conversations about issues, particularly around political campaign seasons, do take place, the overall level of public ignorance is appalling. Here is an entertaining anecdote:

George Bishop and his colleagues at the University of Cincinnati dramatized this point in their study of attitudes toward the “Public Affairs Act of 1975.” Asked for their opinion of the act, large percentages of the public either supported or opposed it, even though no such act was ever passed. In 1995, The Washington Post celebrated the “twentieth unanniversary” of the nonexistent act by asking respondents about its “repeal.” Half the respondents were told that President Clinton wanted to repeal the act; the other half were informed that the “Republican Congress” favored its repeal. The respondents apparently used these cues to guide their answers, without recognizing the fictional character of the entire endeavor.

They suggest that it actually makes sense for the voters to remain ignorant; the acquisition and analysis of adequate information about public affairs is time-consuming and competes with other priorities, and if there is no payoff because your vote really doesn’t matter, why bother? This argument is based on the idea that, usually, one does not see a “direct cost for an ignorant decision” in the political sphere, in contrast to the personal penalties suffered if one does not make an informed decision when buying a car or a house, for example.

While I think that the idea of a Deliberation Day holiday is an absurd way to remedy the situation, I appreciate the analysis. It points to the simple fact that impressing the public with the direct costs to themselves of supporting the present dysadministration, for example, is the most efficient way to regime change in 2004. Of course, nothing in the authors’ examination of the value of deliberation in the political process appears to me to be relevant on a national scale, especially since their central premise that an informed electorate might have genuine, enfranchised power is a political fiction on that scale. I haven’t read their book, but it sounds like it will be a useful study on modern disenfranchisement even though not proposing a useful solution. This is not surprising, since no one really has any useful solutions to the powerlessness of the masses.