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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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May 5, 2011

Translation Needed

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Posted by Derek

The "Opinionator" blog at the New York Times is trying here, but there's something not quite right. David Bornstein, in fact, gets off on the wrong foot entirely with this opening:

Consider two numbers: 800,000 and 21.

The first is the number of medical research papers that were published in 2008. The second is the number of new drugs that were approved by the Food and Drug Administration last year.

That’s an ocean of research producing treatments by the drop. Indeed, in recent decades, one of the most sobering realities in the field of biomedical research has been the fact that, despite significant increases in funding — as well as extraordinary advances in things like genomics, computerized molecular modeling, and drug screening and synthesization — the number of new treatments for illnesses that make it to market each year has flatlined at historically low levels.

Now, "synthesization" appears to be a new word, and it's not one that we've been waiting for, either. "Synthesis" is what we call it in the labs; I've never heard of synthesization in my life, and hope never to again. That's a minor point, perhaps, but it's an immediate giveaway that this piece is being written by someone who knows nothing about their chosen topic. How far would you keep reading an article that talked about mental health and psychosization? A sermon on the Book of Genesization? Right.

The point about drug approvals being flat is correct, of course, although not exactly news by now, But comparing it to the total number of medical papers published that same year is bizarre. Many of these papers have no bearing on the discovery of drugs, not even potentially. Even if you wanted to make such a comparison, you'd want to run the clock back at least twelve years to find the papers that might have influenced the current crop of drug approvals. All in all, it's a lurching start.

Things pick up a bit when Bornstein starts focusing on the Myelin Repair Foundation as an example of current ways to change drug discovery. (Perhaps it's just because he starts relaying information directly that he's been given?) The MRF is an interesting organization that's obviously working on a very tough problem - having tried to make neurons grow and repair themselves more than once in my career, I can testify that it's most definitely nontrivial. And the article tries to make a big distinction between they way that they're funding research as opposed to the "traditional NIH way".

The primary mechanism for getting funding for biomedical research is to write a grant proposal and submit it to the N.I.H. or a large foundation. Proposals are reviewed by scientists, who decide which ones are most likely to produce novel discoveries. Only a fraction get funded and there is little encouragement for investigators to coordinate research with other laboratories. Discoveries are kept quiet until they are published in peer-reviewed journals, so other scientists learn about them only after a delay of years. In theory, once findings are published, they will be picked up by pharmaceutical companies. In practice, that doesn’t happen nearly as often as it should.

Now we're back to what I'm starting to think of as the "translational research fallacy". I wrote about that here; it's the belief that there are all kinds of great ideas and leads in drug discovery that are sitting on the shelf, because no one in the industry has bothered to take a look. And while it's true that some things do slip past, I'm really not sure that I can buy into this whole worldview. My belief is that many of these things are not as immediately actionable as their academic discoverers believe them to be, for one thing. (And as for the ones that clearly are, those are worth starting a company around, right?) There's also the problem that not all of these discoveries can even be reproduced.

Bornstein's article does get it right about this topic, though:

What’s missing? For a discovery to reach the threshold where a pharmaceutical company will move it forward what’s needed is called “translational” research — research that validates targets and reduces the risk. This involves things like replicating and standardizing studies, testing chemicals (potentially millions) against targets, and if something produces a desired reaction, modifying compounds or varying concentration levels to balance efficacy and safety (usually in rats). It is repetitive, time consuming work — often described as “grunt work.” It’s vital for developing cures, but it’s not the kind of research that will advance the career of a young scientist in a university setting.

“Pure science is what you’re rewarded for,” notes Dr. Barres. “That’s what you get promoted for. That’s what they give the Nobel Prizes for. And yet developing a drug is a hundred times harder than getting a Nobel Prize. . .

That kind of research is what a lot of us spend all our days doing, and there's plenty of work to fill them. As for developing a drug being harder than getting a Nobel Prize, well, apples and oranges, but there's something to it, still. The drug will cost you a lot more money along the way, but with the potential of making a lot more at the end. Bornstein's article goes off the rails again, though, when he says that companies are reluctant to go into this kind of work when someone else owns the IP rights. That's technically true, but overall, the Bayh-Dole Act on commercialization of academic research (despite complications) has brought many more discoveries to light than it's hindered, I'd say. And he's also off base about how this is the reason that drug companies make "me too" compounds. No, it's not because we don't have enough ideas to work on, unfortunately. It's because most of them (and more over the years) don't go anywhere.

Bornstein's going to do a follow-up piece focusing more on the Myelin Repair people, so I'll revisit the topic then. What I'm seeing so far is an earnest, well-meaning attempt to figure out what's going on with drug discovery - but it's not a topic that admits of many easy answers. That's a problem for journalists, and a problem for those of us who do it, too.

Comments (26) + TrackBacks (0) | Category: "Me Too" Drugs | Academia (vs. Industry) | Drug Development | Who Discovers and Why


COMMENTS

1. ks on May 5, 2011 7:42 AM writes...

It's called secularism. And it is always wrong-motivated.

Permalink to Comment

2. Rick on May 5, 2011 8:08 AM writes...

Derek,
Thanks for bringing the Bornstein article to our attention. There is one comment of yours I'd like to explore further: "overall, the Bayh-Dole Act on commercialization of academic research (despite complications) has brought many more discoveries to light than it's hindered." What is your basis for making this statement?

My experience has been that Bayh-Dole has hindered far more research than it's helped, from both the industry and academic perspectives. For example, I can't count the number of times I have been in research meetings or discussions where someone brought up a fabulous new technique or tool that could be interesting to try, only to contact the PI and be redirected to his/her tech transfer office, which then proceeded to lay out such unacceptable terms to just give something a try (we're NOT talking commercialization here, just trying something out) that we gave up and used something with less potential simply because it was cheaper/easier to access. Some institutions were so over the top that we decided to pre-emptively gave up approaching them because their terms were so onerous. Taken together, these amount to opportunity costs (e.g. opportunities never pusrued because the institution's tech transfer office was so unreasonable, time wasted pursuing promising technical leads that were logistical dead ends, time and money spent getting a hold of something that failed on the first shot, etc.) that I believe hurt innovation. Every colleague I've spoken with has had the same experience, usually more than once. Mind you, this is a greater problem at smaller companies (supposedly the corporate hotbed of inovation), which have fewer resources to spend on something that the inventor's institution think REALLY IS HONEST TO GOD THE NEXT BIG THING, but I know it affects larger companies as well, insofar as they either cough up the money or reverse engineer the too-expensive technology and dare the institution to come after them.

On top of that, I've found that most academic researchers view their tech transfer offices as speed bumps on the road to finding out if their hard-won discoveries might actually be medically useful. Contrary to the premise of Bayh-Dole, individual researchers are less motivated by the revenue (which they often never see anyway) than they are by beter understanding the implications and potential of their discoveries. Beyond a certain point, which is far lower than Bayh-Dole might contemplates, researchers are less motivated by revenue than they are by the unquenchable need to innovate, at which point Bayh-Dole-created structures become roadblocks instead of enablers.

Surely, you have heard this argument, too. Do you really believe the costs resulting from Bayh-Dole are more than offset by the hypothetical motivation afforded by monetary revenue?

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3. g on May 5, 2011 8:46 AM writes...

With healthcare, it is so easy for people to get their hopes up. There will be some protein whose activity is found to be involved in a particular disease process in an organ system. In the closing paragraph of the discussion section, the authors will say something about how this finding will lead to new cures for disease X.

In reality, this will likely not lead to a cure. Just because some protein/gene/pathway/etc is involved in something, does not mean that it is druggable. For one, the finding may be an artifact of their experimental conditions, and independent labs may not be able to reproduce the finding. Secondly, that protein may be involved in myriad different processes-inhibiting or activating it may cause numerous on- and off-target side effects that would stop any drug development right in its tracks. Thirdly, it may be involved, but not that important in the whole pathogenesis of the disease or symptomatology of it.

All these dashed hopes lead people to believe in some sort of conspiracy by the drug industry, like the drug industry created AIDS or could cure depression/cancer/etc if they really wanted.

Permalink to Comment

4. Bucky on May 5, 2011 8:48 AM writes...

800,000 is the number of papers in pubmed for the year 2008, which is not the number of papers that were trying to develop an FDA approved drug. Bornstein also limits "treatments" only to FDA approved drugs. I'm sure many of those papers developed great new treatments that were not drug related or were follow up studies on existing drugs or combinations of drugs. What about publications on diagnostic criteria? It is hard to treat someone if you don't know they have the disease. I think that 800,000 is off by an order of magnitude (or two).

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5. Virgil on May 5, 2011 8:58 AM writes...

Where to even begin with the misconceptions? This bit, for example, is wrong on so many levels: "... what’s needed is called “translational” research [...blah... blah...] it’s not the kind of research that will advance the career of a young scientist in a university setting".

Oh yeah? Try telling that to the thousands of junior faculty who are having their NIH grants rejected because they're not translational enough! If anything, engaging in translational research is the ONE thing that can advance your career right now!

I'd be interested to see who he interviewed for this piece. Certainly not anyone in academia, and likely no-one currently involved in the pharma industry either.

He also glosses over the HUGE role of the FDA in the current debacle... can you say "bottleneck"? Fix the FDA, and their hang-ups about manageable side effects, and a lot more drugs will flow out of the spigot.

Permalink to Comment

6. Cellbio on May 5, 2011 10:05 AM writes...

"My belief is that many of these things are not as immediately actionable as their academic discoverers believe them to be, for one thing."

That might be the understatement of the year. Having spent the last 3.5 years of my life evaluating and trying to advance start-up opportunities, I would say this is almost universal.

"That kind of research is what a lot of us spend all our days doing...."

And the kind of research that is not understood or valued by most academics. Let me give you an average (OK, maybe lower end of the spectrum) academic's approach to a value proposition: Disease X is really bad (fill in the X with the deadly large market disease that is closest to your area of basic research), we have knowledge about some process of disease X derived from Y (pick one of either mouse genetics, animal models or cell biology). Therefore, we should get money to learn more because it would be great to cure disease X. In cases where they actually have a molecule, it is really fun to ask questions about IP, PK etc. The answers often reveal a total ignorance of the craft of drug discovery and development, and show the academic mindset of the value being the first to show a principle rather than reduce it to practice. Yah, yah, yah (wave hands in dismissive way) ....we can formulate or something to improve PK.....sure, it is a known kinase inhibitor marketed by pharma, but we think they will probably license to us....there was no tox, why?, well, because at the efficacious dose all the rats had their feet on the ground...How do we know the efficacy is mediated by a specific impact when we dosed at 100 mg/kg?, because it is known to have 5 fold selectivity, 10 nM to 50, in cells..... on and on.

In the end, now coming out of a failed academic "translation", I conclude these folks are well trained by their experience, and so, are grant junkies. If their work can be spun to get money, new translational grants, new industry-academia partnering, they will pursue it, but in large part, this will only contribute to the 800,000 number, and we should never expect it to be different. To be sure, there are exceptions, but the vast majority will be following the messianic lead of Dr Collins and the Church of Billion Dollar Big Biology and be pursuing large piles of money, and will continue to mistake cutting edge research for innovative value. Few have a real thing that is useful for a relevant need, but rather the ever present potential that someday some undefined thing might be useful.

However, there is a need, or potential value, to mine this space for the good opportunities that do exist, if only we could figure out the details. VCs have largely left the space (maybe Atlas and a few others remain?). Good work is being done in elucidating biology and target function. In my opinion, the problem is the work stops there, and IP starts, which creates a value gap. The answer is also clear to me. Universities need to hire drug discovery and development folks to participate in this Translational effort. However, they also are hurting big for money, so can this happen? Well, it might, if the Translational field develops and someone sees a competitive advantage to adding former pharma/biotech folks to their staff. Perhaps UCSF is leading in this regard and others will follow.

Permalink to Comment

7. Josh on May 5, 2011 10:14 AM writes...

@Virgil- You beat me to it. Not only does Bornstein seem to have forgotten to talk to anyone from Pharma, I suspect he doesn't even *know* anyone. What a dumb commentary.

Permalink to Comment

8. CR on May 5, 2011 10:31 AM writes...

@Virgil (and @Josh):

You forgot the most important part of his quote (the part that you replaced with [...blah...blah]). Selective quoting doesn't help your argument, by the way.


"This involves things like replicating and standardizing studies, testing chemicals (potentially millions) against targets, and if something produces a desired reaction, modifying compounds or varying concentration levels to balance efficacy and safety (usually in rats). It is repetitive, time consuming work often described as “grunt work."

I can speak with experience that this work is NOT rewarded in a university setting. This is the type of work that industry medicinal chemists do day in and day out and going to a university and trying to get a faculty job will get you nowhere. Most major universities do not see this as something productive - one major university in Boston even states that producing compounds and publishing in journals such as JMC will not get you tenure. Regardless of where those molecules may go (licensing, etc.) it's not "academic" enough to be useful.

Translational research will get you funding, but the "grunt work" will not get you anywhere in the university setting.

Permalink to Comment

9. RM on May 5, 2011 11:08 AM writes...

Derek, "synthesis" is last year's approach. In today's competitive marketplace, stakeholders demand that you have incentivize monetizing synergies - synthesization is not just about making molecules, it's about being proactive in leveraging your paradigm.

Bucky@4 - If 800,000 is for the total number of papers in PubMed for the year, it's even worse than you imply. PubMed indexes *all* the papers in the journals that sometimes carry medically relevant context. That includes the big name journals as well. All the papers from Science, Nature, PNAS, and JACS are indexed. That includes all the articles on high energy physics, plate tectonics, etc. Call me cynical, but I don't think the authors of "Optical absorption and radiative thermal conductivity of silicate perovskite to 125 gigapascals" are even considering medical applications. Even those in biology-specific journals aren't necessarily aiming for a medical treatment anytime soon. "Polymerization of alpha-hydroxy acids by ribosomes" might find a clinical use someday, but I wouldn't hold your breath.

Permalink to Comment

10. Tim on May 5, 2011 11:40 AM writes...

I'm going to add "professional synthesizator" to my resume right now!

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11. Andy on May 5, 2011 11:56 AM writes...

Try telling that to the thousands of junior faculty who are having their NIH grants rejected because they're not translational enough! If anything, engaging in translational research is the ONE thing that can advance your career right now!

This is wrong. True translational (applying basic research to humans) studies at the NIH are scored more harshly and funded less often are "basic science" studies. The NIH claims to want translational science, but the study sections control the priority scores, and they disagree. My guess is that this phenomenon is part of the driving force behind Collins' creation of a new Translational Sciences Institute at NIH. Junior faculty that want to get their grants funded by the NIH should not propose translational research.

Permalink to Comment

12. anonymous academic on May 5, 2011 12:00 PM writes...

I can't count the number of times I have been in research meetings or discussions where someone brought up a fabulous new technique or tool that could be interesting to try, only to contact the PI and be redirected to his/her tech transfer office, which then proceeded to lay out such unacceptable terms to just give something a try (we're NOT talking commercialization here, just trying something out) that we gave up and used something with less potential simply because it was cheaper/easier to access.

I'm assuming you're working in industry, but this turns out to be a problem for academic labs too, especially in the computational sciences. In many (probably most) cases, even when code can be obtained without too many hurdles, I have to go back to the original papers and try to re-implement their methods from scratch if I even want to try it out, lest I be accused of cribbing off the original. (The fact that much of our group's work is also restrictively licensed definitely doesn't set a good example, either.)

That said, Derek recently quoted the statistic that approximately 25% of new therapies/drugs came from publicly-funded research. It's probably safe to assume that most of these wouldn't have made it past the basic research stage without exclusive commercial rights for the companies that developed the actual products. But product development is rarely the actual goal of many tech transfer properties; it's usually just a way to wring money out of any commercial users.

Permalink to Comment

13. MoMo on May 5, 2011 12:18 PM writes...

Why is it everybody believes everything that is written?

By "synthesization" he probably meant Combinatorial chemistry-Pharma's attempt at ruling the molecuale world with its McDonald's-like molecules and assembly lines.

Permalink to Comment

14. partial agonist on May 5, 2011 1:02 PM writes...

Even if 800,000 is right (and it isn't)

If as the author says it is 100 times harder to discover a drug than it is to win a Nobel Prize (perhaps a dubious claim), and if it is also 1000X harder to win a Nobel Prize than it is to publish a paper (I would argue that is, on the other hand, a very conservative estimate)

then 21 new drugs discovered should be equivalent to publishing 2,100,000 papers.

LOL at RM, as I leverage my core competencies to alter the prevailing synthesization paradigm, concurrently creating shareholder value while six sigma-ing everything in sight.

Permalink to Comment

15. Anonymous on May 5, 2011 1:12 PM writes...

Bornstein went to a smarter school than most people, therefore he can comment on any topic.

That's so like the New York Times, it's turned into a rag in the opinion section. The paper is a mouthpiece for the Democratic party, environmentalists and other left-wing pseudo-nihilists. I don't believe anything written in there unless it's corroborated by other sources. Most of the journalists just "make stuff up" and phone it in.

Permalink to Comment

16. johnnyboy on May 5, 2011 1:31 PM writes...

" I don't believe anything written in there unless it's corroborated by other sources."

Other sources like Fox News ?

Permalink to Comment

17. Rick on May 5, 2011 1:44 PM writes...

anon acad (#12),
You assume almost correctly. I am actually industrial waste. My many academic friends say just what you said, I just didn't want to presume. Thanks for chiming in.

As for your second paragraph, I would really like to challenge you and Derek to tell me why you believe "It's probably safe to assume that most of these wouldn't have made it past the basic research stage without exclusive commercial rights for the companies that developed the actual products." I've spent a lot of time studying the history and economics of drug discovery and development and I can find absolutely no basis for that belief in the historical record. Here are a few facts that seem to belie this popular belief:

1. If your statement were an accurate description of reality, the enactment of Bayh-Dole in the 1980s would have been accompanied by a dramatic increase in the flow of novel drugs thanks to lessening barriers for commercialization of academic research. In fact, exactly the opposite happened. Beginning almost exactly the year B-D was enacted there has been an exponential decline in new drug discovery and commercialization.

2. If that statement were true, then during the time when nearly 80% of new drugs originated from academic institutions or private research, the pace of commercialization should have been much slower. It wasn't. In fact, depending on the year, new drugs were discovered and commercialized at a pace that was up to 20-fold greater than occurred post-B-D.

3. In the 1950s and 60s, it was the norm for academic research to form non-exclusive research partnerships with corporations and receive no formally contracted downstream payments or royalties such as encouraged by B-D today. Moreover, as exemplified by Jonas Salk's famous line "Could you patent the sun?", such arrangements were viewed as ridiculous. Yet those academic-corporate partnerships somehow managed to crank out massive numbers of new drugs, like ALL of the classes of antibiotics we have today, and vaccines at a rate that hasn't been duplicated since.

There's a lot more data that is quite simply inconsistent with the common notion that potential drugs or drug discovery technologies need some kind of legally sanctioned, for-profit system such as that arising from Bayh-Dole to enable them to be commercialized. The most significant legacy of Bayh-Dole that I can see is that it has turned university tech transfer offices into de facto revenue generators, which may have helped money flow to university endowments, but it hasn't helped discoveries flow toward application any faster than if these constraining systems had not been created.

Based on the historical evidence, it is UNsafe to assume that most new therapies/drugs coming from publicly-funded research wouldn't have made it past the basic research stage without exclusive commercial rights for the companies that developed the actual products. No doubt Bayh-Dole was well-intentioned, but all the historically-consistent evidence I've seen says its unintended consequences that hindered inforamtion exchange far outweigh any benefit it might have done for advancement of academic biomedical discoveries toward commercialization.

Permalink to Comment

18. Todd on May 5, 2011 1:46 PM writes...

I have a modest proposal for improving the likelihood of academic research translating into industry and the clinic: mandate GLP for anyone getting NIH grants. I'd even offer one time grants to any facility receiving NIH grants to help get their acts together. A lot of this stuff that doesn't translate would disappear, because it would either be exposed as part of the secret sauce or, somewhat less likely, reveal something that can be replicated and transferred over to industry. Also, conduct random sweeps, with a failed GLP audit meaning refunding of grant money. If the only incentive academics respond to is grant money, use it.

Do that, and I think a lot of issues are solvable, if not necessarily solved. Also, I think there should be a limit to the phenomenon in Comment #3. Yes, something can lead to a cure or treatment for XYZ, but there needs to be an acknowledgement of the whole long process to developing those treatments.

Permalink to Comment

19. Still Scared of Dinosaurs on May 5, 2011 2:46 PM writes...

Gee whiz, Todd, next thing you know you're gonna want gov't and academic clinical researchers to adhere to GCP. Which they probably think they do.

As far as Bayh-Dole goes, one thing it has done for sure is raise the cost of getting going by generating tons of crap patents. I'd like to see realistic estimates of how often promising tech sits on the sidelines because the patent situation is so murky.

And I'd feel a lot better about tech xfer turning into a cash cow if the overall costs of going to these institutions weren't going up so much. Remember, the harder the science the more its students are being subsidized by everybody else.

Permalink to Comment

20. DLIB on May 5, 2011 3:07 PM writes...

I have encountered a similar issue with the Tech transfer offices...they figure that since most companies that license their tech will fail, royalties will never be realized. Upfront cash is something they can touch. Universities thought the Bayh-Dole act would be a new way to bring in the dough. Has not happened. So what are the metrics the managers at those tech transfer offices are measured against??? It prompted me to read the rest of the Bayh-Dole Act. :-)

Permalink to Comment

21. Rick on May 5, 2011 4:59 PM writes...

DLIB (#20)
It's one of those things that, the more you start to think "something's wrong here".

The answer to your question, "So what are the metrics the managers at those tech transfer offices are measured against???", in cases I'm familiar with, is "net revenue", not "technologies transferred". In the cases I've examined, tech transfer offices have explicit performance goals to be revenue-generating and show positive year-upon-year net revenue growth. Not surprisingly, they're motivated to minimize overhead/internal costs and maximize out-charges as much as the market will bear. It also means institutions with higher cachet charge a premium based solely on their "brand". It's basic free market economics.

Permalink to Comment

22. Boo on May 5, 2011 8:30 PM writes...

Whenever someone says "translational research," I feel like I'm being conned.

Permalink to Comment

23. BlueBaron on May 5, 2011 10:44 PM writes...

It seems that a lot of the management types like university patents because they don't want to develop something that doesn't have any IP protection. This may translate into, "we don't want to develop anything that we can't fully monopolize." A sort of minimization of risk and maximization of potential market dominance.

I think Bayh-Dole has done universities and the US a great disservice because it has turned educational institutions into profit institutions, and they profit by restricting the use of research that was conducted in the public interest with mostly public money. In the country I currently inhabit, they highly encourage research that can be patented and spun-off into business. But like so many universities, their interest in business is solely for money. The universities are money mills, and they miss the point because by monetizing, and thus restricting the products of publicly funded research, they are cutting out the value of the research to the public. Their demands for upfront cash in exchange for speculative, undeveloped technologies stems from the same attitude where they don't give a crap about public interest, or for the players who want to reduce their half-assed "innovation" to practice.

At the least, there should be a reform to B-D so that "inventions" can be used for basic research and development, and must be licensed to players who are ready to commercialize through some sort of binding arbitration or a set royalty from derived products. Letting universities be the middleman between industry and the so-called public "investment" in academic research is akin to telling your VC investors to screw-off.

Permalink to Comment

24. Anthony on May 6, 2011 10:43 AM writes...

But comparing it to the total number of medical papers published that same year is bizarre.
It might make more sense if there was more than one year's data - the metric is very rough, but how many papers were published in 1978, and how many new drugs were approved that year? Is the ratio within an order of magnitude of 40,000:1?

Permalink to Comment

25. Biased agonist on May 6, 2011 12:28 PM writes...

Another misconception: It's incorrect to state that "Discoveries are kept quiet until they are published in peer-reviewed journals, so other scientists learn about them only after a delay of years."

Maybe someone should tell D Bornstein about scientific meetings, or what a congress or symposium is... This is where you get the heads up about what's going on, months - sometimes more than 12 months - before publication in a peer-reviewed journal. And if the discovery is really "hot and translatable", well, one can always look in the patents literature.

Permalink to Comment

26. Rick on May 6, 2011 3:04 PM writes...

Anthony (#24),
I think Derek's point (and I agree with him) is that you need to compare the number papers published in a given year with something much earlier in the drug development process than approval, especially if you're trying to make a point about drug discovery productivity. Otherwise you're comparing completely unrelated things (drugs approved in year X with discoveries about potential drugs that won't be drugs until year X+12).

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