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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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September 2, 2009

Lexapro, Forest Labs, and the Hard Sell

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Posted by Derek

Forest Labs has done very, very well with Lexapro (escitalopram) over the years. They're a comparatively small company, and their collaboration with Lundbeck (also a comparatively small company) in the antidepressant field has been the biggest event in their history.

Lexapro is the pure enantiomer of the earlier Lundbeck drug Celexa (citalopram), and it's been a very successful follow-on. (For a nasty spat over generic production of citalopram, see here). I'm generally not too keen on the follow-up-with-the-single-enantiomer strategy, I have to say. In general, I think it's slowly disappearing from the world as regulatory agencies look down on racemic mixtures. (I've never worked on a program myself where we seriously considered taking a racemate to the clinic - we always assumed that we'd end up developing a single enantiomer).

The New York Times has an article out detailing some of Forest's marketing plans, as revealed in documents before a Senate committee. Some of what the article has to say I agree with, and some of it I have to raise an eyebrow at, and we'll get to both of those. First off, in an area as large and competitive as antidepressants, I don't think that anyone should be surprised at what was in Forest's plan: lots and lots of lunches for physicians' offices, plenty of continuing medical education lectures (with plenty of food), and so on. One line shows that the company budgeted $34.7 million dollars to pay 2,000 physicians to deliver about 15,000 talks on the drug to their colleagues.

The Senate seems to be shocked at all this - well, pretending to be shocked, because no national politician can ever really be surprised at any way that money is used to influence anyone's decisions. But I'm not shocked, either. Leaving aside (just for a moment) the question of whether drugs should be promoted this way, the fact is that they are promoted this way, and have been for a very long time. And breaking down that lecture figure, that means a bit over $2,000 per lecture, and we don't know if that figure is supposed to cover just the honoraria for the speakers, or the whole cost of the lectures. Even if we assume the former, that comes to nearly eight lectures per physician per year, giving each of them about $17,000, pre-tax. Compared to the cost of advertising in the medical journals, general-interest magazines, or especially on television, that probably represents an excellent return for the money.

And Forest has been spending plenty of it. The article mentions that Vermont, for example, found that Forest (despite their size) was outspent in that state only by Lilly, Pfizer, Novartis, and Merck. Considering that those companies have many more drugs to sell than Forest does, that's an impressive figure. Of course, the only reason you spend money on marketing is to make even more of it back in sales, and they've certainly been doing that, too.

There are several questions here, and perhaps it's best to take them one by one. First off, is Lexapro worth what people (and insurance companies) are paying for it? The snappy economic answer is that of course it is, since that's the price that's willingly being paid, but let's talk utility instead. It does seem to be a good drug, arguably better than many of the others. It's been run head-to-head with Cymbalta (duloxetine), which is no poor performer itself, and shown to be superior And earlier this year, a Lancet article analyzed 117 controlled trials and found that there were clear clinical differences between the various antidepressants, and that Lexapro and Zoloft (sertraline) stood out as better than the rest.

The article recommended starting with the latter in new patients, I should note, and sertraline's now generic. I think that Forest's battle in the market is both against their similarly expensive competitors (where I think that they can claim to have an edge) and against cheap sertraline, where they may well not. (Update: and against their own (now generic) racemate - I'm digging into that comparison, and it'll be the subject of a follow-up post.) That said, depression is a famously heterogeneous field, and patients often have to try several drugs before somethings works, for reasons that are unclear. So yes, overall, I think that Lexapro is a useful drug, and that patients are getting benefit for their money.

The New York Times article is rather disingenuous on this point, by the way - you'd never know from it that there were differences between antidepressants, since they treat Lexapro and Prozac as interchangable, and you'd never know that there was evidence that Forest's drug might well be near the top of the list.

Next question: is Lexapro worth what Forest is spending to promote it? That question also splits into two, economically, depending on what we mean by "worth". As in the price question, from a strictly accounting perspective, we have to presume that Forest is seeing a financial benefit from their marketing activities; marketing does not run at a loss, not for long, it doesn't. And from a utility/societal benefit perspective, if Lexapro really is superior to most of their competitors, then I think the company is justified in making that case as loudly as they can.

Now we get to the tough one: are Forest's marketing activities appropriate or ethical? The arguing can now commence, because this is where we try to figure out what "as loudly as they can" actually means. I think the industry would be better off if there were less of an arms race in the marketing area. (Update: just to pick one benefit, it would make us look, in general, less sleazy, which is not to be underestimated). Even though marketing doesn't run at a loss, the return from it could be still higher if it were less expensive to do. Huge sales forces are expensive, and one of the reasons the sales forces are so big is that the competition's sales forces are so big, and so on. It's hard for any one company to climb down from its position, just from a game-theory point of view, so the most likely way for this to happen is through across-the-board restrictions on marketing, as enforced by the FDA, the FTC, or by physicians themselves. (I should mention, though, that there has been a voluntary retreat in the area of brand-covered swag). We're already seeing this pendulum swing back in the last few years, and it's fine with me if the process continues for a while longer. Doctors are perfectly free to close their doors in the faces of drug reps, and if I were in their position, I'd be tempted to do just that in many cases.

So if we come back around to that Times headine, it reads "Document Details Plan to Promote Costly Drug". And to that, I can say yes, it's a costly drug, set as high as the company thinks that people will pay for it, and to a level that they think they can make the most money with before its patent expires. And yes, Forest has a plan to maximize those profits, and if I were a shareholder (I'm not), I'd be righteously steamed if they didn't. And they did indeed write that plan down, so there are plenty of documents. I'd rather, myself, that the plan looked different than it does, and that's the way the world seems to be heading. But no matter what regulations come into force, there will always be plans to promote things that cost money.

Comments (38) + TrackBacks (0) | Category: Business and Markets | Drug Prices | Press Coverage | The Central Nervous System | Why Everyone Loves Us


COMMENTS

1. Barbara W. on September 2, 2009 10:14 AM writes...

You did not address the issues of paying physicians to promote the drug for use with children, or the generic drug which is so much cheaper. Those are both incredibly important.

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2. barry on September 2, 2009 10:36 AM writes...

much as we like to think of Pharma companies as research organizations, the numbers tell a different story. A majority the the budget at any big pharma company is spent jockeying for market. Except for Lilly, most are currently run by marketers. From the Executive suite, research is an expensive side-venture, and Marketing is the company's mission.

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3. Kismet on September 2, 2009 11:10 AM writes...

That's disgusting. If physicians read those f*cking review articles, they'd know which drug to prescribe and companies wouldn't waste millions of dollars on such disingenious crap.

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4. Cloud on September 2, 2009 11:12 AM writes...

@Barbara W- Derek DID address two generic-related issues. What generic issue did you want him to address?

Derek, I agree with you on the advertising thing- I think we'd be better off as an industry with less of it. It would certainly take away one of the sticks we frequently get beat with. I don't know why people seem think that the pharma companies should just get together and decide to stop advertising in certain ways. In what other industry has that ever happened? I'm not even sure it would be legal- I wonder if they'd run afoul of antitrust laws? PhRMA isn't doing itself any favors if it is lobbying hard against new rules regulating advertising, though.

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5. Don Monroe on September 2, 2009 11:17 AM writes...

Is there evidence from trials that different antidepressants work for different patients, or is all anecdotal?

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6. Palo on September 2, 2009 11:32 AM writes...

Derek, you deliberately avoided the main point of the NYT article, which was the marketing plan to make patients switch from Celexa to Lexapro, when both Forest and the FDA see them as the same drug. This is to me the key paragraph:

"Forest’s executives and paid consultants have long implied that Lexapro is superior to Celexa and other antidepressants. But the Food and Drug Administration did not require Forest to test this theory in any statistically valid way. The F.D.A. views the two medicines as so interchangeable that the agency recently approved Lexapro’s use in depressed adolescents based in part on the results of a study Forest conducted using Celexa."

The article was not about comparing Lexapro to Prozac.

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7. David Quigley on September 2, 2009 11:38 AM writes...

Derek, your writing is great, but "the price that's willingly being paid" is not a thoughtful thing to write. Prescribing doctors don't pay out of pocket for the drugs they give patients. Consumers do not choose to pay for prescription antidepressants the way they pick brands of dishwasher detergent, and the market for drugs is highly distorted by the payment system. The fact that "Forest has recently been raising the price of Lexapro to make up for a decline in its use" tells you how far from an efficient market this is.

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8. barry on September 2, 2009 11:40 AM writes...

For decades, a gentlemen's agreement among drug companies blocked advertising prescription drugs directly to patients. That ended with Minoxidil, and I don't know how to stuff the genie back into the bottle. All the companies know that for many diseases it's a zero-sum game in which they compete to grab patients from each other. The exceptions--hairloss, Erectile dysfunction...--in which the market actually is elastic have come to define the marketing strategy for all drugs.

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9. partial agonist on September 2, 2009 11:44 AM writes...

the old "beat them over the head about marketing when they should be spending it on research" cry.

Rank these businesses by percentage expenditures on R&D, less to greatest, and advertising expenses, most to least:

consumer supplies (eg Proctor and Gamble)
electronics companies (eg Sony)
telecommunications leaders (eg Nokia)
software companies (eg Microsoft)
Pharmaceutical companies (eg Pfizer)

Hint: they are alreay in order, least R&D money spent by percenatge to most, and most advertising & marketing dollars spent to least. And there is a big gap between software & pharma (10.5% vs. 17.5% spent on R&D)

I'd recommend anyone read an excellent little book "Drug Truths" by John LaMattina.

Pharma is a whipping boy, sometimes deserving, but mostly not

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10. Derek Lowe on September 2, 2009 11:46 AM writes...

Palo, I actually got so tangled up with the later points that I didn't get back to that one. But I'm going to make it the subject of a whole separate post, which I hope you'll find satisfying. Once it's up, you can tell me what my motives were then, too. . .

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11. SRC on September 2, 2009 11:58 AM writes...

Abstract of the NYT article: Forest, like every other business, does what it thinks will promote its interest. Just as the NYT does, although sometimes I'm not so sure.

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12. J on September 2, 2009 12:44 PM writes...

Note that citalopram was one of the 12 drugs in the Lancet meta-analysis, yet it was not one of the two recommended drugs (escitalopram and sertraline).

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13. J on September 2, 2009 1:04 PM writes...

Don,

The trial was STAR*D, supported by NIMH.

"The STAR*D trial provides robust, real-world data that can be applied broadly to both primary and specialty care settings. The study confirms that different people respond to different treatment strategies, but it does not pinpoint what treatments work best for whom. The STAR*D team concluded that future research should be targeted to identify the best multi-step treatment options for individuals, especially those with treatment-resistant depression."


http://www.nimh.nih.gov/health/trials/practical/stard/index.shtml

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14. CMCguy on September 2, 2009 1:44 PM writes...

#9 post does show reality vs. perception that is the mantra of many. Although IMO Pharma probably spends "too much" on marketing, particularly certain types it is curious to see how much of NCI spending (tax dollars) has growth and is now large percentage for "non-research activities" as illustrated in the NYT graph tracking 40 years "war on cancer" http://www.nytimes.com/imagepages/2009/06/28/health/28cancer.grafic.ready.html

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15. Muscle on September 2, 2009 2:38 PM writes...

I suppose tomorrow Derek will comment on Pfizer being hit with the largest fine in US history over deceptive advertising.

http://money.aol.com/article/pfizer-to-pay-record-23b-penalty-over/652045


Pfizer is such an EVVVVIL company.

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16. Kismet on September 2, 2009 3:17 PM writes...

partial agonist, that's a surprsingly bad defense. The little difference is that pharma is not Procter, Sony, Nokia or Microsoft. Pharma companies *are* different. They *should* have the least expenses (in a perfect world: none) for marketing - so in how far is your list surprising?

People really and needlessly die if you screw up. Period.

It doesn't matter how pharma screws up, but we must do something about it, if possible. In this case it seems more like a lack of regulation anyway, although, barry suggests that there used to be some sort of "agreement" between companies. Why not have it back w/ some regulation?

What else of relevance to clinicians and patients alike is there to a drug than the god damn evidence from clinical trials and meta-analyses? (+pricing)
Every penny that goes to marketing is a waste and harms real people. Sure, the system is FUBAR'd and marketing will always be needed, but we should try to make it better wherever possible: direct to consumer and direct to doctor marketing must go.

If doctors (or their 'superiors') were educated one could expect them to review the friggin' evidence and make the best choice without any outside interference - I assumed that's what they have been trained for. Why am I wrong?

...and I am equally disguested by the money that Intel et al. waste on marketing. It just has less direct consequences.

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17. metaphysician on September 2, 2009 4:13 PM writes...

Am I the only one confused by the level of venom to the very concept of 'marketing'? There is not, and never has been, a product or service that could sell with zero marketing.

Like it or not, pharma companies are in the business of *selling* drugs. It really should not come as a shock that they are going to, gasp, sell them.

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18. Hap on September 2, 2009 4:26 PM writes...

Well, because marketing (or rather overmarketing) has led to many of the debacles that have eroded people's trust in and support of the pharmaceutical industry and cost it lots of money in legal fees and PR? Because the hard sell is a short-term profit tactic that damns you (and your employees and stockholders) in the long term (perhaps why one uses it only where one doesn't intend to be around afterward)? Those seem like good reasons why pharma marketing (and the management that enables, and the stockholders who empower them) has earned the venom it receives.

If your product works well and does something useful, how much advertising do you need? When many (if not most) of the people you're advertising to are unlikely to be able to assess the risks and benefits of what you're selling, which is what we ask of people, might direct advertising seem like a problem? Pharma is a life-giving business, and it seems both incongruous and eventually problematic that its products be sold like timeshares in the middle of nowhere, or used cars, or snake oil.

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19. Cloud on September 2, 2009 5:55 PM writes...

@metaphysician- I actually think Pharma should be allowed to market their products, but that there should be extra rules governing how they do so, because the consequences of false or unfair marketing practices are more severe for a drug than for, say, a blender.

I'd get rid of direct to consumer marketing about specific drugs, although I'd probably be OK with some educational campaigns about diseases and disorders.

I'd restrict how pharma can market to doctors, too, perhaps limiting them to handing out reprints of peer-reviewed write ups of clinical trials. Of course, as we've seen with the recent ghost-writing debacle, this approach can be gamed, too.

I mainly think that people more knowledgeable about pharma marketing and its good and bad effects than I am should sit in a room and come up with some potential rules, which my elected officials can vote into effect (probably after mangling them with changes).

The idea that some people seem to have that pharma should just stop using certain marketing methods on their own is what strikes me as naive. Pharma companies are businesses. If we want them to behave differently than other businesses we have to make rules that will change their behavior.

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20. Kismet on September 2, 2009 6:24 PM writes...

metaphysician, I really hope you are. How can you not be appalled at the billions that companies like intel waste on marketing? Why not make it hundreds of millions for marketing and instead develop better products?
Marketing should always be as low as possible, but it's a vicious circle. Unfortunately marketing works and pays for itself while R&D (at least for Intel) will hit diminishing returns. (Overblown) Marketing *is* poison, but the system is FUBAR'd and we need to live with it and change it for the better whenever possible.

But as pointed out the consequences are much more severe for pharma companies. We need regulation, don't we?
I believe that educating doctors would help, teach them how, encourage and possibly pay them for the effort to review the literature *neutrally* -- (almost) no direct marketing needed anymore.

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21. The Pharmacoepidemiologist on September 2, 2009 7:25 PM writes...

There's a very easy way of dealing with such situations--just stop allowing marketing expenses to be deductible for health care items. At that point, a lot of this wasted money won't be spent on such hare-brained schemes.

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22. Jose on September 2, 2009 8:07 PM writes...

Pharmaceutical products are NOT normal consumer products, and to treat them that way and allow DTC advertising is idiocy. A drug isn't a Toyota compact and comparisons to other industries is using just straw-man tactics.

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23. Chemjobber on September 2, 2009 8:30 PM writes...

I think that DTC needs to be dialed back, sure, but I'm not aware of the strictures on DTC pharma ads that other industries have.

Unless, of course, I've missed that part of the Chili's ad where it says "Eating this product will probably make you fat and gassy -- check with your dietitian before ingestion."

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24. Matt on September 2, 2009 10:42 PM writes...

Several other commenters have noted some of the issues I had with your commentary, but I'll put my spin in.

Derek, you keep mentioning that marketing costs are always, in the long term, justified by sales. Why do you think that? How do you know, for example, that a particular industry isn't especially profitable and can afford rather large amounts of not clearly justified marketing costs, if they are protected in some way from competition (eg large barriers to entry)? How do you calculate the ROI of a Formula One racing team sponsorship? In a competitive free market, a competitor selling an equivalent product would be able to underbid by spending less on marketing--but you've already given up equivalence (in the antidepressant market), as has the industry (in general) because no one here is suggesting we end patent protection. Why do you think free market economics must apply to sharply curtailed and limited markets, such as the patent-driven, doctor-directed, 3rd party paid, pharmaceutical industry? There's very little resemblance to a free market. This mirrors what David Quigley said, but less succinctly. :)

Unlike other posters, I don't have a problem with advertising, per se. However, bribery in ALL of its forms must be fought. It usually masquerades as gifts or presents or goodwill gestures. It is a VERY effective marketing technique. Just destructive and costly to society. Generating conflicts of interest as a marketing plan is suspicious at best, and bribery at worst. "It's harmless." If it were truly harmless, it would not produce any results.

The second negative aspect to pharmaceutical marketing is that it claims to provide critical information to doctors on the one hand, and take advantage of the flexibility (freedom from truth) we afford marketing claims on the other hand. If TAG body spray doesn't attract women to me irresistibly as it implies, I'm merely out a few dollars. Easily attainable experience can sort out the claims. And no one expects marketers to bring up the downsides to their products. Critical information, on the other hand, requires as complete a disclosure as possible, and as little bias as possible. It is easy to see there will be conflicts between the two at times.

The third negative aspect to pharmaceutical marketing are the examples of wrongdoing. Hap mentioned these in his post. We've seen ghostwritten articles, massive unmentioned conflicts of interest, fatal complications denied/covered/unmentioned for as long as possible, doctors paid to promote off-label use. (Were the claims valid? If you want to be able to make claims that aren't fact-checked, you'd be an idiot not to make your first few claims as credible as possible.) As many other posters have pointed out, this misconduct has cost lives and has contributed to the very high cost of health care.

This misconduct is almost invariably accompanied by claims that these are industry-standard practices, nothing unusual was done, as if widespread dishonesty leading to fatalities or mistreatment would be okay as long as it is the norm. Of course those claims are self-serving, but they need to be taken seriously, because they might also be true. It's unfortunate, but they have damaged the credibility of the industry.

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25. LFree on September 2, 2009 10:42 PM writes...

Of course #15, it's almost the end of summer, and DL hasn't thrown his chemist's flask of boiling water and solvents on the current #1 company. Why focus on this positive NY Times article (and admittingly partial spin) ( http://www.nytimes.com/2009/09/02/health/research/02cancerdrug.html?em ) for some forward thinking in contrast to other failing dinosaurs, when you can concentrate one's clever prose on old marketing malfeasance? Might as well slam the Wyeth thing while you're at it, indeed. So how about it, eh.

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26. LFree on September 2, 2009 10:44 PM writes...

Of course #15, it's almost the end of summer, and DL hasn't thrown his chemist's flask of boiling water and solvents on the current #1 company. Why focus on this positive NY Times article (and admittingly partial spin) ( http://www.nytimes.com/2009/09/02/health/research/02cancerdrug.html?em ) for some forward thinking in contrast to other failing dinosaurs, when you can concentrate one's clever prose on old marketing malfeasance? Might as well slam the Wyeth thing while you're at it, indeed. So how about it, eh.

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27. Matt on September 2, 2009 11:45 PM writes...

J,

If you were saying there are scientific (vs anecdotal) studies showing various antidepressants have different efficacies, I certainly agree. If you meant to imply these studies showed a clear difference between citalopram and escitalopram, I'm not convinced.

The STAR*D study did not study differences between citalopram and escitalopram (you probably know this), because it assumed the first drug to be assigned would be citalopram and looked for the best alternatives when that first treatment did not work.

The Lancet article I haven't jumped through the hoops to read, but I wonder if the cost-benefit analysis would be quite different under the NHS system. Are the prices different by a factor of 10 to 20 there? Were they (c. and esc.) distinguishable from each other in data (the FDA seems to think not, in efficacy) or simply by the coverage of the articles being reviewed?

LFree, are you saying all this talk about malfeasance is depressing you?

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28. LFree on September 3, 2009 12:49 AM writes...

No, why? The future is for the future thinkers and doers. What may depress others?

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29. milkshake on September 3, 2009 3:49 AM writes...

Citalopram (celexa) prescribed to undiagnosed bipolar patient is likely to have worse complication than for example mis-prescribed Prozac.

Citalopram wears off much faster (which is supposed to mitigate sleeping problems common with many SSRIs) but the wide serotonin fluctuations are more likely to cause mood swings in bipolar patients, up to the point of triggering a frank mania-episode. This is not a widely appreciated problem.

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30. anonymous on September 3, 2009 6:17 AM writes...

I assume that #3 does NOT refer to those review article written by a team hired by Wyeth and "authored" by academics.

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31. Don Monroe on September 3, 2009 7:51 AM writes...

Thanks for the link to the STAR*D study, J (#13).

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32. Hack on September 3, 2009 8:40 AM writes...

I think better real world collection of data and information would allow us to more efficiently change the way pharma markets its products. If doctors could (and IMO were mandated to) review real world post-approval data of drugs introduced to market and patients were allowed access to this info as well, we all could make more informed decisions without being at the mercy of the better marketer.

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33. jgault on September 3, 2009 3:49 PM writes...

"Doctors are perfectly free to close their doors in the faces of drug reps, and if I were in their position, I'd be tempted to do just that in many cases."

Man, you have not seen some the reps I've seen.
I would never close a door on those faces.

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34. TX Raven on September 4, 2009 9:25 PM writes...

Perhaps you are not aware that the case of escitalopram is not just a chiral switch?
I wonder if you are aware of the work reported in Psychopharmacology (Berl). 2004 Jul;174(2):163-76, "Escitalopram versus citalopram: the surprising role of the R-enantiomer." A Pubmed search will reveal additional work.
"CONCLUSION: The R-enantiomer present in citalopram counteracts the activity of the S-enantiomer, thereby providing a possible basis for the pharmacological and clinical differences observed between citalopram and escitalopram."

Cheers,
TX Raven

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35. James74 on February 6, 2010 6:52 PM writes...

Being a Pharmacist, I find physicians will use citalopram over iscitalopram 90% of the time. And why not? The end result coupled with no increase in toxicity is what matters to most physicians. Haven't found anyone willing to go to the mat with PBMs for iscitalopram yet. By the way, a lot of Forest Labs products are of the me too variety. Abbott/Synthroid Forest/Levothroid. Abbott still cranks out methamphetamine as far as I know. I love this business.

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36. Graciela on October 12, 2010 3:27 PM writes...

do you have program that paid for Lexapro
send me telephone number by e-mail

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38. Paris Mcdilda on March 29, 2014 1:14 PM writes...

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