Mommy, Where Do Drugs Come From?

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pillsDepending on Mom’s point of view, those big breakthroughs can be traced to either the NIH or the pharmaceutical industry. As you can imagine, a great many people would like to set Mom straight. And so a trio of think tank researchers has released a study they argue shows the ‘private sector’ was responsible for crucial discovery or development of three dozen widely used drugs or drug classes.

Which drugs? Among those cited are the Gleevec cancer med, the Epogen anemia treatment and the Taxol cancer drug, as well as various advances and specific meds among such classes of drugs for treating cholesterol, blood pressure, pain, heart irregularities and HIV/AIDS.

“Such scientific advances can be classified as the basic science of biology and disease processes relevant for given medical conditions; the applied science of discovering compounds that treat particular conditions; and the development of compounds with improved clinical (medical) effects, of large-scale manufacturing processes, and the like,” write Joe DiMasi and Christopher-Paul Milne of the Tufts Center for the Study of Drug Development, and Ben Zycher of the Manhattan Institute.

“Why is the record of private-sector scientific contributions to the development of new medicines important? If the centrality of pharmaceutical research funded by the NIH is the reality -if private-sector research and development investments do not yield important scientific advances - then policy questions surrounding drug prices (federal negotiation of prices for Medicare Part D; importation of price-controlled medicines from abroad; FDA regulation of the industry) might be easier to resolve,” they argue.

In staking out their position, they hammer, in particular, Marcia Angell, a former editor-in-chief of The New England Journal of Medicine, who has taken an opposing view of the subject. The Tufts Center, by the way, is partially funded by the pharmaceutical industry and the Manhattan Institute is known for its conservative views. (UPDATE: See the discussion in the comments about MI’s leanings and funding).

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  1. “The Tufts Center, by the way, is partially funded by the pharmaceutical industry and the Manhattan Institute is known for its conservative views.”

    I think the last part especially, re: the Manhattan Institute, can be rightfully (leftfully?) be characterized as quite an understatement.

    One of M.I.’s fellows coined the phrase “axis of evil” for our current Prez. Receiving significant funding from big tobacco, they lobbied hard against the “dangers of second hand smoke.” Its leaders are consider the gurus of “tort reform,” and the Institutue sponsors both Overlawyered (a blog) and Trial Lawyers, Inc - a kind of lurid report about all the “judicial hellholes” out there. Guess where they stand on preemption.

    This is a far right outfit.

  2. I haven’t read the report and wonder if I’m on shaky ground here (a caveat): NIH’s mission is not to develop drugs and it only retains a patent if a private partner chooses not to pursue development. Given that universities are not in the drug development business, other than for spinning off start-up firms with seed money to start development, I wonder if the deck is stacked for any analysis. My assumption is, of course, assuming that the Tufts people are looking at the owner of the patent that is associated with a NME. (or multiple patents). I freely admit this is an ignorant post.

    I seem to recall that taxol came out of the NIH library and was out-licensed to BMS, as one example.

  3. I only skimmed the beginning of the report/study…

    I don’t really see how you can hope to dissect the two. Look at epogen (since it’s the easiest one to make my point with).

    Sure a company synthesized it in bulk, tested to make sure it worked, and proved it worked. But an enormous amount of NIH supported work helped develop the tools to sequence proteins in general, sequence this protein, and develop the recombinant technology to synthesize proteins in general. Both the company and NIH supported research contributed to an understanding of erythropoetin’s function.

    I suppose a company came up with the “idea” of which patients could benefit from epogen - but frankly, IMO, unlike everything else in life, the “idea” is the easiest part of drug development.

  4. How come reporters bend over backwards to point out when an organization has conservative ties but don’t do the same for liberal ones? Marcia Angell and Harvard are not unbiased entities. They tilt extremely leftward. If it is worth pointing out conservative ties to an organization the same should be done for the other side.

  5. Definitely is not black & white as I agree with Bob and Jack2 as NIHs mission is not necessarily to directly discover or more so develop drugs however the fundamental work done there regularly is part of pharma projects. I see no problem with this as they are a publicly funding agency (world class) devoted to enhancement of knowledge and as such most the efforts are freely available to academia and industry(s) (again globally) benefit/enablement of further work to applications. The NIH also provides a resource of solidly trained people in R&D programs making it harder to draw lines of distinction. It benefits both sides to have strong relationships in seeking solutions to treatments and cures and that should be goal of both more than who gets credit.

    Bob my recollection is paclitaxol discovery came from the NCI/RTI efforts (and may be one of few possible successes of the “war on cancer”). BMS still contributed much to making it available (I have not read full report either to see what focus emphasized).

  6. Bob, Jack2, and CMC make excellent points, in my view. It is very hard to tease apart the contributions of NIM, academia, and industry, and the criteria for counting would be important to look at.

    Re: Mick’s point, I don’t think Harvard (Marcia Angell’s organization) goes out of its way to spread an ideology (beyond institutional self-promotion). The Manhattan Institute does. It would be proud to be called a conservative think tank, and - for those who agree with that view of the world - there is no reason it should not be.

    As for reporting, I’m pretty sure if Ed posted a report from the Center for Progressive Reform, Union of Concerned Scientists, or Public Citizen, their overall political views would either be obvious or would be noted. A name like “Manhattan Institute” could mean anything, and so the leanings are not obvious in the title.

    In the meantime, if anyone is interested in major funders of the M.I. google around with the Olin Foundation, Scaife Foundations, and Smith Richardson Foundation. You’ll learn some interesting things. If you include the searchwords, “tobacco” and/or “pharma” and/or “thalidomide” it is also an education.

  7. Hi Justice,

    Yes, the Manhattan Institute is known to receive funding from pharma, although that isn’t readily clear from its website. MI, in fact, does a poor job of specifying the sources of its outside corporate funding. Nor is the info specified on its 990 tax form. If I’m wrong, I’m happy to be corrected, by the way.

    That said, perhaps neo-conservative is a better label. As an example of its leanings, the MI helped jumpstart the high profile now enjoyed by Bob Goldberg, who left the think tank to co-found the Center for Medicine in the Public Interest and DrugWonks.

    Regards,
    ed

  8. Hi Mick,

    I do try to point out connections whenever possible. If Marcia Angell, for instance, is backed somehow by individuals or groups who oppose a pharma issue, I would be happy to note that. Similarly, if Tufts is backed by pharma and espouses a view endorsed by - or sympathetic to - pharma, that gets noted. There is no double standard. It’s a question of having the info to work with, which I try to obtain whenever I can.

    Hope this helps,
    ed

  9. Agree, Ed. It’s pretty easy to get reasonably good background on the _whole range_ of think tanks and similar via cites like Center for Media in the Public Interest and just plain googling.

    As I understand it, pharma is somewhat less directly involved in funding MI than Big Tobacco and the best known conservative (neo and not so neo) foundations I mentioned - Scaife, Olin, et. al. But they have been very active in pharma-related issues, particulary re: fighting any limits on DTC and preemption. Lots of overlaps with groups like the Washington Legal Foundation, Federalist Society, and American Enterprise Institute, though somewhat right of the AEI.

    Also strong links with the New York Sun which is unabashedly, and proudly, neo-con as we’ve come to know them over the past decade or so.

  10. JIM you state “I don’t think Harvard (Marcia Angell’s organization) goes out of its way to spread an ideology (beyond institutional self-promotion).” You’re right they may not “go out of the way” but certainly do advance a mainly an elitist/liberal ideology (in addition to the self-promotion). As the post suggest Marcia Angell is a strong advocate of “NIH, not industry, has invented all important drugs” with anti-pharma ideology (see her book) which I believe the report is written to address.

    I have scanned the report and in general appears to be factual (based on details I know directly) they seem to weight heavy the development costs and later activities aspects (which are typically major expense/time portion) to support the position (not surprising approach). Again I think too complicated to give a precise answer on who/what is (most) responsible for a drug. Every case is different and takes info and work from so many sources which rarely can define the true and complete path.

    It did confirm my understanding of paclitaxel history that I learned in grad school.

  11. CMC Guy, I agree with your earlier post that BMS did an exceptional job in developing paclitaxel. While I forget the actual price at launch, I recall it started a firestorm of criticism. NIH was pressured to increase its licensing fees/royalties and resisted on the basis they did not have the expertise in-house to negotiate market-driven royalty rates. (was this around ‘93?)

    I don’t recall a more recent example of a drug developed from a CRADA that got as much attention.

  12. I spent a little time with the MI report. It appears to me to be collection of PR positioning statements which attempt to “prove” their point through rhetoric. Some of the industry contributions are dubious, and certainly were not pursued for altruistic motives.

    I’m not clear on where is the problem. NIH/NIM/NCI and all the rest of the public alphabet soup exist for a reason. PhRMA companies also exist for a reason. Both have different roles/ missions. Labelling one or the other as more important/better seems to me to be neither a conservative nor liberal concept. Instead, I suggest that it is reductionism.

    Of course, there is a large market for that sort of thinking, and it sure is nice to come to simple, tidy conclusions.

    I would think a reasonable person could understand the mutually beneficial interrelationship of the public and private entities in all scientific advancements. It’s not perfect, because there are still good prospects for commercialization which aren’t pursued because industry can’t figure a way to protect their investment in commercial development. At the same time there are disease states for which there is so little basic knowledge, treatment innovations are not very likely any time soon.

    The system isn’t perfect, but I’m not hearing either side proposing a reasonable solution to improve on the situation at hand.

  13. Matt,

    I believe that reason that this report exists is to counteract a vocal group who regularly state that academia and the NIH “invent” all drug and that the pharma industry just feeds off of their work. In reality, as you point out, each plays a vitally important role and together are the reason the US continues to produce more pharmaceutical innovations than the rest of the world (although the gap is ever narrowing). While we know the partnership is critical, there are other forces that seem intent on breaking it apart.

    Atlex

  14. Atlex,

    I think you’ve nailed the likely intent, else why would they spend so much time “refuting” Dr. Angell’s interpretations of the specific drug development events.

    However, by attempting to refute the argument, and going nowhere on addressing the merits and demerits of the existing (de facto) system, the report doesn’t move the debate forward. The important question would seem to be: “How do we ensure continued progress in medical innovation to improve the lives and health of those who come after us?”

    Instead (to my reading), this debate is framed as: “Who gets credit for all the good that has been done?” Personally, I don’t care about credit - that would seem to be the responsibility of the Nobel Prize committees.

    When NIH and other publicly funded science is under constraint because of the need to spend more on military actions, PhRMA should support the need for more public science, not participate in an arguement over who does the greater share of the work.

    There is no acknowledgement of several issues which I think are key in the debate (that should be taking place). My list of issues includes:

    1) Publicly funded science is often directed disporportionately to “popular” causes which are not necessarily areas most in need of additional (especially basic) research.

    2) Considerable amounts of publicly funded science (not the basic science/benchwork stuff which is often not health related) goes toward areas which will never have practical applications - these are the studies which Jon Stewart, Jay Leno, et al. make fun of. I would argue that virtually all money spent on space exploration or astronomy - anything where the orientation is AWAY from our planet - is a waste.

    3) Commercialization is not pursued on some very good ideas because noone can make the return on investment work out, or because the perceived risks seem prohibitive. Consequently we still have nothing for pre-eclampsia, work to decrease disability among preterm babies is glacially slow, etc. I could go on right up to end-of-life issues. I still know good ideas from the early 90s which will never see the light because there is no way to recoup/protect the investment in development. Truly, public money could be used to insure a certain return on some of those ideas, but this would mean creating a new model of public/private partnership in health innovation.

    4) Much of the “innovation” coming from PhRMA these days has more to do with continuing a revenue stream than with delivering additional value to patients and physicians. In the 80s and 90s there were “me-too” drugs - some of which actually had enough differences to be useful in specific situations. These days it seem that we are getting a large number of new delivery systems (sustained release, transdermal, oral dissolving tablets, etc), and metabolites or single entity isomers. Sometimes a controlled release mechanism can be a significant improvement (ER calcium channel blockers or ADHD stimulants, among others as example), but by and large these opportunities have been exploited. The isomer/metabolite modifications may show some theoretical differences, but for the most part these are clinically irrelevant/indistinguishable from the parent. They do help prop up next quarter’s earnings estimates, but these are what I call non-novations.

    I’m sure others could add to the list. This is just what springs to mind on a Wednesday morning when I’m taking a day off. I’m not a Key Opinion Leader on this issue, and the folks conducting this debate are supposed to be the smart ones. I don’t work for Harvard, or a think-tank (conservative, liberal or otherwise). I know they are more accomplished, and likely they are in fact smarter than me. However, I’m not impressed. I don’t see this debate (like so many others) leading us forward.

  15. From my perspective, this is a good discussion, if nothing else than for underlying and perhaps clarifying more specifically the ways public and private research initiatives interact, the range of consequences, the various ways that can be analyzed in order to create debating points on all sides, etc..

    Small point re: Harvard - Having known the institution for several years both inside and outside, I’d be hard-pressed to describe their overall take as “liberal.” I think their overall take is “what is good for Harvard.”

    Biederman (who has received much comment here lately) is as much a part of the franchise as Angell. And you have a very wide cast of characters beyond.

    Dr. H. - I always appreciate your thoughtful and informed comments. I thank you once again.

  16. M. Helm,

    I thnk you are correct in your view; unfortunately, the attacks by Angell at al have gotten traction politically. As a result, PHRMA sponsors or encourages reports of this type to support its position. In the end, academia, NIH, and PHRMA all recognize that they need each other to fully drive innovation. Unfortunately, politics may get in the way of productive collaborations.

    Atlex

  17. Agree with Atlex that the battle is political. I’m not sure how much it impacts actual collaborations (he or others may well know). But it certainly impacts public perceptions.

    The “critics” major points and their rebuttals - pricing, me-toos, costs of devel/marketing - need not be reiterated. Personally, I have not “profited” (so to speak) from Angell’s work in terms of even framing the debate. Her writing reminds of Joan Baez - it all kinda sounds the same (sorry Baez fans).

    On the other hand, Goozner takes up some of the same issues for a “general audience,” and I believe more usefully, if not without his own “slants.”

  18. Dr. Helm I appreciate (support) your well expressed list and wish indeed that such will be the focus moving forward rather than distraction of telling our children who is most important. However Angell’s view, based on what I have seen and heard, is largely accepted by public and media without analysis or understanding.

    I work in R&D side so know neither side is giving the true picture of how science/drug development works (and where improvements required, cf your list) and do take it personally insulting that what I do is not understood and tossed out because it does not fit with predetermined conclusion. As suggested the current system is dominated by politics (and more so money) so we tend to stumble around without real solution offered/implemented.

  19. Thank you M. Helm (and others) for a very insightful post. Years ago a “chicken and egg” question was posed: does policy drive research or does research drive policy? I’m afraid a new variable has been added that alters the equation–does spin drive research and policy or vice verse? I’m afraid we know.

    This is not to challenge the integrity of the Tufts group–they work is highly credible and has been validated, but, as typical, the outside spinmeisters have run with it.

  20. CMC Guy - Without asking you for a treatise, I’d be really inerested in your take on what in Angell’s et. al. pop analyses seem most off course. Your R&D experience is obviously to the issue, and I would like to learn from that. Thanks if you have time/inclination.

  21. JIM inclination yes, but time to devote may be unavailable till weekend so please don’t feel slighted if do not get back for a while. I can suggest that you look at Derek Lowe’s In the Pipeline blog to likely find others who agree (& disagree). One post is partcular dealt with issue at hand.

    http://pipeline.corante.com/archives/2007/09/12/drugs_from_where.php

  22. Many thanks for the link, CMC Guy. I look forward to spendng some time with the content.

    although JIM didn’t ask me the question, that’s never stopping me from weighing in. Angell is aligned with those who believe profit has no basis in health care delivery–perhaps that’s an oversimplification, but convenient for a blog. I have no quarrel with her postion because she’s consistent in her values and perspectives.

    A harsh interpretation of her position is that she lacks a fundamental understanding of economics, markets and intellectual property and won’t give an inch in recognizing their validity.

    Still, she’s relevant. So are her opponents.

    Never the twain shall meet

  23. I think the fundamental reasoning behind the conclusion is flawed:
    —–
    Without the scientific advances yielded by private-sector research, most drugs would not be developed, and thus the economic returns to publicly funded research would be sharply reduced. These figures strongly suggest that policies yielding a reduction in private pharmaceutical research and development would reduce sharply the economic benefits of NIH research efforts, as well as the immense medical benefits derived from the continuous development of new and improved medicines.
    ——

    First of all, it’s obvious that if drug companies produce the drugs, they need to do applied research and development as part of the commercialization process. So, “proving” that private firm R&D was necessary to get these drugs to market isn’t a huge accomplishment.

    Second, I don’t know of anyone who is recommending policies to reduce private sector R&D. It is possible that an adverse effect of some policies, like drug price controls, COULD lead to less R&D spending by big pharma, but it’s not a certainty. Big pharma has been cutting its R&D spending in general (as a % of sales) in any case, because they get higher return on investment from spending on marketing.

    Third, just because drugs developed in the past were made possible by big pharma R&D doesn’t mean that there is no alternative model. The basic problem is that as long as the entire cost of drug development is so high, big pharma is going to be driven to develop “blockbuster” drugs rather than pursue alternative products that could have equal or greater social value. So the most pressing issue is how to increase the efficiency of the drug development process (get more and better drugs into the market at lower cost), not how to maintain or increase R&D spending by drug manufacturers.

    It still astounds me that money is spent on a report that (a) states the obvious, and (b) presents a conclusion that does not reflect thea actual findings of the research.

  24. For Bob and all - If I pose a question to whomever, all are always welcome to weigh in. I’m sure we all feel similarly. And, from her too, thanks for the link!

    Marcia, Marcia, Marcia. She was certainly one of the first to bring these quesitons into the current public debate. However simplified or distorted some may view her perspectives, she has stimulated further discussion that (pollyannish moment) will help clarify the issue Bob raises - pharma as a business, pharma as a profession, pharma as a third thing which does not easily fit into any of our usual ways of thinking about the roles of regulation, profits, serving the people, etc. in this context.

  25. In fairness to her, and she needs no defense from me, she raises the issue of marketing expenses vs. R & D. very effectively. Industry tries to explain it away by pointing out that Phase IIIB and Phase IV research is included but when you figure it costs about $200K annually per sales rep, the marketing costs add up pretty quickly. (The $200K is salary plus fringe, bonus, car, etc.) And, when one recognizes that Phase IIIB and IV research is for marketing purposes (and sometimes for new indications) it doesn’t strenghten their argument.

    (Sorry I don’t have a link/reference for the cost/rep.)

  26. JIM Hit & Run without any time to go into whys but at least two Angell portions that I find Incredulous (Extracted Source Wikipedia, believe represents what I have read elsewhere)

    1) The few drugs that are truly innovative have usually been based on taxpayer-supported research done in nonprofit academic medical centers or at the National Institutes of Health.
    2)The pharmaceutical industry estimates that each new drug costs them $800 million to develop and bring to market, but Angell and Relman estimate the cost to them is actually closer to $100 million

    If Bob is correct about “profit has no basis in health care delivery” faction I would also say is off course there(Don’t MD get paid rather well in most cases?)

    Bob $200K seems low for Sales type but assumes does not cover Med. and other Benefits.

  27. I really wish I could find a reliable source for the $200K but I haven’t. It’s also now a dated estimate, at least a couple of years old.

    Agree with your hit and run. I’m in the same category today.

  28. Thanks for the H&R, guys. I think the $800 M figure is now officially upped to one billion according to PhRMA. It is richly debated by many. Goozner and Public Citizen also take issue with the industry claim, but with different esitmates, based on somewhat different grounds, than MA.

    As you know, the opportunity cost half is one place where opinions sharply diverge.

  29. JIM I don’t know if this comes off as a “treatise” and sorry if not on point to what you are seeking but reflects how my opinions regarding things said by (or attributed to) Angell.

    1; Drug Innovation. As noted earlier public/private contribution issue not B&W since tends to be intertwined thus not easy to separate out what is “more” important (see below). It is like describing a trip and depends on what is part talked about. One can focus on the preparation and packing then the start of journey. Otherwise may talk about excitement of reaching the destination, review of stops/sights along the way or the price of gas/flat tires/wrong turn/getting lost. Same trip may be spin into mini-tales that have different significance to listeners even though is a single event.
    In terms of predicament defining innovation I offer a comparison example: was Henry Ford an innovator in automotive industry (homage to MI?)? He neither invented cars nor the assembly line concept, it has been argued most of what he did do was based on others ideas. Does that deflect from the accomplishments and industry that resulted? He accumulated a fortune, does that make him evil?
    Here’s the puzzle. I apply a reaction learned in grad school (funded largely by NIH grants) to develop a novel and scalable route (patented) to make a drug. The drug being developed came from a small biotech through collaboration with a university lab (not sure which was source of idea) but required a fair bit of optimization before candidate selection. Previous syntheses were technically problematic, barely supplied clinical demand and not commercially viable (bench level). The new chemistry allowed multi-kilo production thus progress into multiple clinical studies which ultimately lead to approval. Fellow lab mates, other support groups, pilot plant and manufacturing personnel all involved in the implementation. The project along the way faced formulation issues, analytical challenges, supply chain issues, chemical hazards, regulatory hurdles and marketing questions (plus possible list of other details). Do I credit NIH for financing my education which lead to the connection and application I was able to make? I am thankful but I would look more to my Prof, who obtained the grant, assigned me the project and guided me for several years. The reaction came from literature out of Japanese university which I found searching myself after chemistry recommended by Prof was unsuccessful.
    The attitude expounded by Angell and others appears to only focus on the “collaboration with a university lab, NIH funding, Japanese university” as the keys. I don’t ignore that such was present but without all the stuff done by industry people the drug never would have made it in to patients.

    I won’t have time to go over costs of drug development issue(s). You are correct that newer number is >$1B (I just pulled line as is) and I understand controversial nature of calculations. I can say have seen Phase 3 studies costs projected at $30-60M (not accounting for earlier R&D) so it doesn’t take much to blow past the $100M mark.

    Sorry if seem trapped in refuitiation mode as I do agree heartly with Dr. Helm’s list and need to move forward. It hard to sit still when such BS (not the degree kind) comes out of “educated” people and then public/media take as “truth”.

    We can argue about Harvard’s leaning and lawyer another time.

  30. CMC - Thank you for taking the time to explain the situation you did. I think it is exactly such particular cases that we need to get beyond the “who gets credit” debate which, as we all seem to agree, is mostly a political club used by each side to bash the other. Just as you suggest, when you get down to particulars, the generalizations of talking points don’t last very long. This is very valuable stuff, and - yes - not what makes easy headlines.

    I carry no brief for Harvard, btw. Last time I was there (my 25th reunion) some guy from the contribution committee (I guess their equivalent of marketing) literally berated our class and said, almost in these words, that we “owed Harvard” several million bucks based on what other 25th anniversary classes had given. And we had better pay up. Pronto.

    So, to me, Harvard is mainly a brand name, and obviously a pretty successful one.

  31. JIM- you’re welcome. I trust you catch I am (mostly?) poking fun at Harvard (and Lawyers too) and I actually have had friends from both so am redirecting some of those interactions since you can sound like them at times. If I offend please ignore and accept unintentional nature.

  32. All is well; I’ve always appreciated your comments. As I think you know, I am not a lawyer, even though I’ve been active in the preemption issue and a few others that have legal aspects. Luckily, Harvard did provide me with some very smart roommmates who are high-falutin’ lawyers (corporate, government, labor, et. al.) so I ask them about the law, and they ask me about fly fishing.

  33. CMC, and others, thanks for the kind comments over the week.

    CMC, I particularly like your analogy and illustration of the drug development story as a journey. What seems to be topic of this particular debate is who gets most credit for the trip - the travel agent or the airline pilot?

    One of the stories about Mr Ford’s genius was that he intended to build a car every working man could afford. Problem was he couldn’t do it initially. His solution: pay his workers more money, so they could afford to buy the product they made. The story goes that this drove up wages among other employers around Detroit, expanding the base of potential customers even more. (At the time, auto manufacturing was a far more local phenomenon.) I believe this to be a true story, though I haven’t thoroughly researched it. I’m not creative enough to have invented it myself.

    I have a recollection of hearing Dr. Angell at a plenary session at some convention I attended in the past few years. I can’t recall which one, but I remember the arguments being made, with the clear presumption that PhRMA and BIO companies were profiteering usurpers. I recall finding a fair number of assumptions in the arguments unsound, and I’m pretty that after a few minutes, I just started reviewing my itenerary for the day. I was left with a profound unasked/unanswered question at the end: “So what?”

    I think we are all obligated to ask these authorities - regardless of the tilt of their argument: “Assuming you are correct, what difference does this make? How are you proposing to improve innovation, expidite new discover, development and commercialization of technologies proven to provide real value to people suffering from significant medical problems?” Maybe I should throw in a question about how to reduce the costs and improve the likelihood of success.

    If I ever have the opportunity again, I will do my best to ask. Keeping with the car theme, I recall one of the US companies briefly adopting a slogan of “lead, follow or get out of the way.”

    Bob Freeman is correct about critiques (Dr. Angell’s and others) regarding promotional spending vs. R&D. There are issues there, and they are not new. But that’s also a different discussion. If physicians really cared about the balance of R&D versus promotion, they could simply refuse to see reps and refuse to accept samples. (This was a different plenary speaker topic.)

  34. Ford’s very complexity may be relevant to the discussion. On the one hand, much of what Dr. Helm writes is, as far as I know, correct. Ford’s use of the assembly line in innovative ways was also, of course, key to the company’s success. Those were the days, in Motown.

    And, at the same moment, Ford was virulently anti-immigrant, isolationist, anti-union, and anti-Semitic. The relevant history and his relationship with Nazi Germany/Hitler up to the outbreak of WW2 need not be reiterated.

    What’s the relevance? Ford’s success and genuinely good intentions in many areas, I believe, is part of what blinded him to his weaknesses and limits of vision. I think there is a lesson there for all essentially “good institutions” and especially if they are successful and large - pharma, Harvard, and even lawyers! The “bigger” they are, the more careful they need to be.

    Ford was an essentially moral guy who became, at certain points in his career, a grandiose, even hateful, moralist. In his way, he, too, was involved in a narrowing either-or obsession over “who should get the credit” (and who is to blame).

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