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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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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

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August 17, 2012

Good Forum for a Response on Drug Innovation?

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Posted by Derek

I wanted to mention that a version of my first post on the Light/Lexchin article is now up over at the Discover magazine site. And if you've been following the comments to that one and to Light's response here, you'll note that readers here have found a number of problems with the original paper's analysis. I've found a few of my own, and I expect there are more.

The British Medical Journal has advised me that they consider a letter to the editor to be the appropriate forum for a response to one of their published articles. I don't think publishing this one did them much credit, but what's done is done. I'm still shopping for a venue for a detailed response on my part - I've had a couple of much-appreciated offers, but I'd like to continue to see what options are out there to get this out to the widest possible audience.

Comments (23) + TrackBacks (0) | Category: Drug Development | Drug Prices


COMMENTS

1. Dylan on August 17, 2012 7:39 AM writes...

Derek,

I know that you've been a guest blogger at The Atlantic a few times, and that seems like a pretty good place to get a more generalized audience of the type that could benefit from a well thought response. Slate is of course another option, since they were one of the ones that picked up on the earlier Light piece.

Seems a more mainstream audience for this kind of thing would benefit a lot more than a response in BMJ or comparable publication, where you would more likely be preaching to the converted.

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2. davesnyd on August 17, 2012 7:58 AM writes...

I'm not sure that you and Light are talking *to* each other; I think you're talking *at* each other.

Correct me if I'm wrong, but the crux of the question is his claim that R&D costs for a drug are $43M on median to the company while the industry quoted number is typically something like $1B or $2B.

I don't think they're measuring the same thing. I think that's implicit in his comment here:

"Our estimate is for net, median corporate cost of D(evelopment) for that same of drugs from the 1990s that the health economists supported by the industry used to ramp up the high estimate. Net, because taxpayer subsidies which the industry has fought hard to expand pay for about 44% of gross R&D costs. Median, because a few costly cases which are always featured raise the average artificially. Corporate, because a lot of R(eseach) and some D is paid for by others "“ governments, foundations, institutes. We don't include an estimate for R(eseach) because no one knows what it is and it varies so much from a chance discovery that costs almost nothing to years and decades of research, failures, dead ends, new angles, before finally an effective drug is discovered."

Specifically, I think he's excluding the clinical trial costs in that. That's the only way his $43M can ever make sense. As long as you and he are comparing apples and oranges, there will be no resolution.

Look, this debate is interesting to those of us who read this blog because it affects the economics of this industry and also how it is perceived.

But it doesn't get to the heart of what I (and I suspect many of your other readers) feel is critical to our own microeconomic well being: whether the cost of creating a new entity is in the sub-$100M or over-$1B range, the cost of the discovery medicinal chemistry research is well under $1B. So, I think, many of us wonder why is *that* number the one that is used for justifying slashing and burning in discovery chemistry?

Permalink to Comment

3. MTK on August 17, 2012 8:28 AM writes...

@2,

How exactly do you get that Light doesn't include clinical costs from that quote? What am I missing?

Even if that is so, how can you exclude clinical costs from development costs? That would be like excluding the engine in the cost of a new car.

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4. davesnyd on August 17, 2012 8:53 AM writes...

So I'll grant that I'm not seeing him explicitly exclude clinical costs. But otherwise, I don't see how the $43M pricetag he cites makes any sense-- given the high cost of clinical trials.

My comment is not addressing development costs. It's trying to point out that the total cost of drug development is widely used as justification for reducing expenditures at one of the least costly (but intrinsically critical) steps in the process: basic discovery (and, for that matter, "development" in the pharmaceutical sense of process chemistry and formulations and so on).

Minimizing chemistry costs by firing researchers and closing down sites in the US does little to address the real cost problem in bringing a new entity to market-- which is largely clinical.

The standard Libertarian approach is to eliminate the regulations that require clinical testing (or, at least, water them down). There's something to be said for trying to reduce their costs by streamlining them and looking for "bang for the buck" least costly regulations that provide sufficient protection.

It's worth considering: if we, as a society, wish to subsidize new pharmaceuticals, perhaps we do that by either paying for the clinical trials-- or paying for the clinical trials or a significant fraction of them in areas that we feel are underserved. For instance, orphan drugs or the neurological area (Derek has often written of how difficult that space is to work in and, as a result, how few therapies there are).

It's also worth asking whether industry has done what it can to minimize clinical costs by making rational decisions about which compounds to promote to the clinic and, most importantly, to phase III. See: http://pipeline.corante.com/archives/2012/07/24/bapineuzumab_does_not_work_against_alzheimers.php, specifically:

"That's because the Phase II data weren't too encouraging, press releases aside."

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5. Anonymous on August 17, 2012 9:02 AM writes...

@2,

Seems like the only thing Light is admitting in that quote is that their calculation does not include a cost estimate for the "research" part of R&D.

Even if they are not measuring the same thing, the perception to 95% of the people who see the $43M number is that they are measuring the total cost of R&D for one drug.

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6. Hibob on August 17, 2012 9:10 AM writes...

@Derek: Slate or Wall Street Journal.

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7. mass_speccer on August 17, 2012 9:20 AM writes...

Derek,

Not sure exactly what sort of response you're writing, but it would be nice to get it somewhere peer-reviewed. That might be rather a lot of work of course. You could then easily cite it in a letter to the editor of BMJ. It always seems nice to have something on the record in the journal the original article was published in.

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8. Lyle Langley on August 17, 2012 9:51 AM writes...

As an editor of a journal, I find it interesting that this is being done outside the confines of the journal that published the original article. I understand the "need" on Dr. Lowe's part to use his forum; but, if there is an issue with an article that is published, a letter to the editor should be the first course of action. They will (or should), in turn allow Dr. Light a rebuttal. Then if Dr. Lowe is unsatisfied, alternative methods can be employed. But not allowing the journal and the author a chance for rebuttal all you have is, well, an internet comments page - regardless of where your exception is taken (here, The Atlantic, WSJ, etc.).

Write your piece, allow the journal to have it reviewed appropriately and then allow Dr. Light a chance in the appropriate forum. If you don't follow this avenue, it's clear all you want to do is complain and claim "victory".

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9. MoMo on August 17, 2012 10:10 AM writes...

"The British Medical journal has advised me..blah blah blah....letter to the editor." Must have you shaking in your boots! No more Andrew Lloyd Weber tunes for you!

Go public with this battle and go large, Derek. Mainstream America would be appalled at the British mocking the Drug Industry in here.

How many drugs come from the UK I wonder? Study that Light!

The Phantom of the Opera is here! To give you a drug for 43M! (Plate on Face)

Permalink to Comment

10. Hap on August 17, 2012 10:15 AM writes...

1) It seems to have been an article with what should have been recognized as serious flaws from the outset - given that they were unable to recognize those flaws (and the authors still seem to be willfully blind to the flaws in their argument), I'm not sure why arguing in the pages of their journal (or having them review the discussion) is likely to be useful or effective.

2) Paying twice for discussion of a bad article seems unjust, similar to paying for a retraction of an article that shouldn't have been published.

3) The article is a political piece - the use of bad logic and data to justify the authors' political ends. Given that, it would be better to aim at the real target audience - the public - than placing a response (perhaps) in the same journal which is unlikely to be seen by the people targeted by the original article (or, rather, by the people who are likely to use the original article to justify their actions).

Review of Dr. Lowe's logic would be helpful, but that is what's going on here, and what BMJ could do if they wished. Any journal with reviewers competent to give good arguments is probably preaching to a choir who already knows the music and words very well, and who will be the only ones to hear their music. Better to refine arguments in public where everyone can see them and evaluate their logic and publish them in a place that will make the original article ineffective as the political tool it is intended as.

WSJ might be best, but it may make it easier for those who don't like your logic to ignore it based on the politics of the source publication. The Economist doesn't have the same problem, but it doesn't have enough readership, either.

Permalink to Comment

11. sigma147 on August 17, 2012 10:44 AM writes...

@8 - Unfortunately, despite a journal editor's best (or worst) intentions, debate of a politically and socially charged article such as this one will not and cannot be limited to a polite give-and-take on the pages the publishing journal. The reasons for this fact should be quite clear: such an article, through the simple act of publication in a prestigious, peer-reviewed journal, has a wieght of veractiy behind it that will influence public debate of the subject matter. Moreover, given that the subject matter is of a highly public nature, and has a direct impact on policy discussions, keeping the discussion behind a pay wall and within the confines of the editor's purvue simply isn't feasible. That horse has left the barn.

Surely Dr. Light is quite aware of the controversy his paper would touch off, given past experience with similar, highly charged paper publications. To insist that the appropriate forum to debate these points is found within the confines of the publishing journal is the height of hubris, unless the journal editor is arguing that the subject is of no interest beyond the scope of academic debate.

Permalink to Comment

12. BCP on August 17, 2012 10:51 AM writes...

This is a very interesting topic. Not the Light article but the "how best to respond," one.

I agree that, a traditional letter to the editor is an appropriate way to respond - frankly, I was/am expecting that to happen in some way. The problem with that approach is how long does it take to get your response published? The sensationalist headlines have come and gone, and the audience that is really being addressed here *ISN'T* the readership of the BMJ. I'd argue that this is about public opinion and all those who sieze on this second hand. With that in mind, finding a way to address this in a more timely manner, in a public venue which can be easily referenced/linked is an acceptable first response. Do we think that the contributors and readers of Slate will be eagerly pawing through BMJ over the coming weeks in hope of finding a balanced counterpoint to the original article? Of course not.

Permalink to Comment

13. WCA on August 17, 2012 11:11 AM writes...

Derek,

What is your company's take on all of this? I'm assuming that you'll need corporate sign-off on something that's going to be formally published somewhere. Do they want one of their own squaring off in a public forum about the pharmaceutical industry?

For that matter, do they have to sign off on what you write here or your guest op-eds as well?

Permalink to Comment

14. Bruce Hamilton on August 17, 2012 1:30 PM writes...

If your article is a summary of why their number is outside other peer-reviewed articles ( eg journal of health economics ), then the formal letter to the editor could be an option. It won't change any stances.

If you want to refute in detail, then an article in another journal may be best ( NEJM, J.Health Economics etc. ).

If you want to respond to the wider audience then perhaps a general article in an online publication or NYT with pointers to a post here with all the details for the interested.

None of which will correct the misperceptions arising from the original article errors that have been picked up by the media wanting a good story.

Permalink to Comment

15. MIMD on August 17, 2012 6:43 PM writes...

#8 Lyle Langley

We live in an Internet age. The influence of the mainstream journals is waning.

re: if there is an issue with an article that is published, a letter to the editor should be the first course of action.

I think it appropriate to utilize all mechanisms of information dissemination. The advantage of blogs: they are not subject to potentially biased editing or biased peer review, nor subject to the time delays that letter submission entails. The advantage of journals: they reach a wider domain-specific audience.

The mantra of "responding to an article in the journal in which it's published" (with the implication that response anywhere else is in any way improper) is quite pre-Web.

I write for a multi-author blog ("Healthcare Renewal") and my topic is healthcare informatics. My posts are often 'iconoclastic' (e.g., strongly defensive of patient's rights with respect to experimental IT) and probably would not have made it into the mainstream journals in my field, but have reached people who count. For example, I note that the blog has "hits" daily from sites such as senate.gov, house.gov, cdc.gov, fda.gov etc.

The posts also rank highly on Google searches on topics written about.

I think both venues, blogs/websites and journals, are appropriate and warranted in 2012 regarding interesting and/or controversial matters.

Permalink to Comment

16. MTK on August 17, 2012 7:40 PM writes...

@8,

I actually found your response quite humorous.

Clearly your dry wit was lost on the comments which followed. The quaint concept of responding with a letter to the editor of the journal was bit of wonderful whimsy harkening back to the prior millenium.

Let me add that Drs. Lowe and Light could then travel the lyceum circuit debating their respective positions to rapt audiences in river towns all along the Mississppi.

Permalink to Comment

17. Lyle Langley on August 20, 2012 8:06 AM writes...

#15, MIMD:
"The advantage of blogs: they are not subject to potentially biased editing or biased peer review, nor subject to the time delays that letter submission entails."

The other advantage of blogs...any quack can say what they want without having any review of any sort. Sorry, blogs are blogs, you want a true response, put it through some form of review. This response would be in contrast to what was written, so if there are sources to cite, make sure it gets reviewed appropriately. Otherwise, it's simply internet chatter.

Permalink to Comment

18. Homer on August 20, 2012 6:17 PM writes...

Season 4 of The Simpsons:

Even the supporting actors and guest stars shine in season four. Phil Hartman gets his best role in the series as smary huckster Lyle Langley, who attempts to convince Springfield it needs a monorail ("Marge vs. the monorail") and The Red Hot Chili Peppers will make you shit your pants laughing in "Krusty Gets Kancelled".

Permalink to Comment

19. ba on August 21, 2012 8:00 AM writes...

@17 Lyle Langley-
You can find utter crap in the blogosphere, and you can find utter crap in the peer-reviewed, published lit. I expect you won't try to argue with that. Crap is crap and unfortunately no forum is immune.

Permalink to Comment

20. LatetoTheParty on August 21, 2012 4:34 PM writes...

I guess the debate has passed on now, but I would add this: Derek should post his responses according to which audience he wishes to reach. The original response was published in a clinical research journal which presumably is read and reviewed primarily by medics with their own biases as to how drug development works. If Derek wishes to reach medics and clinicians and respond to the warped picture that Light has painted, it seems he should publish in Br Med J or another journal. If he wants to publish in a journal respected by drug industry researchers then there is Nature Reviews Drug Discovery or any ACS journal or any other numerous titles. If he wishes to reach the public then open access journals and blogs seem to be the way to go.

Permalink to Comment

21. MIMD on August 21, 2012 4:44 PM writes...

@17. Lyle Langley

You commit the logical fallacy of composition.

Since you seem mired in the past, try searching the Forbes and NY Times-recommended healthcare blog I co-write for, Healthcare Renewal, on the term "ghostwriting."

Also see my post "Dr. Silverstein and Dr. Poses in WSJ: The Literature Is Hardly Pristine" at http://hcrenewal.blogspot.com/2011/04/medinformaticsmd-and-dr-roy-poses-in.html

Make sure to check out the link to my post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" in there as well.

And search Little Green Footballs on "Rathergate."

Permalink to Comment

22. MIMD on August 21, 2012 4:58 PM writes...

@17

Also want to add: with apparently rigid view such as yours on the disruptive innovation in information diffusion made possible by the Internet and blogs, I'm not sanguine about how you would react in objectively reviewing a scientific article that also challenges the dominant memes, whether well referenced or not.

Permalink to Comment

23. M on March 25, 2014 12:05 PM writes...

Does somebody know where this response was ultimately published?

Permalink to Comment

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