The Op-Ed: More Trouble In 2012 Or A Renaissance?

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dan-hoffman-twoA new year often brings new contemplations about what the future holds. And the pharmaceutical industry is no different, especially during this ongoing period of transition and tumult. Over the past couple of years, though, many pharma execs have gazed into their crystal balls and claimed to have discovered a new paradigm that can soon be expected to change the way things are done. Daniel Hoffman, who is president of the Pharmaceutical Business Research Associates consulting firm and a weekly pharma blogger at The Philadelphia Inquirer, tells us what he thinks of the prognostications…

Pharma does not appear content to let the various soothsayers, savants or its legions of critics project the industry’s course for the New Year. Their public relations specialists have instead crafted a message claiming that Big Pharma has uncovered a research paradigm that will bring a raft of breakthrough compounds to regulatory submission. The only fly in this golden ointment, according to the PR yarn, consists of “the way its development process is regulated by the Food and Drug Administration” (see here).

The story is familiar and contains just a scent of plausibility but, so far, its results have remained entirely in the realm of fantasy. According to its foot lickers, Big Pharma has learned several important lessons over the past decade. These include the knowledge that drug discovery is not “scalable,” so a larger research enterprise doesn’t create more or better results. At the same time, the over-merged behemoths also learned to put the pursuit of primary care blockbusters in their rearview mirrors.

Armed with this awareness, pharma now maintains the blissful attitude Herbert Hoover projected at the depth of the Great Depression when he said, “prosperity is just around the corner.” The story claims that the “targeted” approach to “rational drug design” is poised to produce “‘game changing’ innovation” in under-served therapeutic areas such as Alzheimer’s, stroke and cancer. It appears that only big, bad government can impede this boon for mankind.

Pharma’s PR campaign is faulty in both its premises and its conclusions. First, the malefactors who manage the Big Pharmas didn’t really “learn” anything new because they knew at the time that their metastasized research groups were unproductive. Eight years ago, for example, The New York Times published the results of interviews conducted with several top researchers who had recently left GlaxoSmithKline (read here). They roundly complained about disorganization, red tape and top scientists obliged to waste their time flying back and forth between the US and the UK. More extensive analyses at the time (see this) described an industry that was “out of control.”

Similarly, stories appeared 10 years ago that told of pharma having already picked the “low-hanging fruit” as far as developing primary care blockbusters (look here). So pharma managements knew what they were doing all along when they concocted unproductive mergers to save their own jobs by pumping earnings growth from layoffs and cash flow.

But what of predictions for a golden age of new drugs just around the corner? Western cosmology ever since Isaac Newton and Francis Bacon rarely makes it easy to disprove predictions about the future, hence the ability of first-class loons to command attention when they regularly announce the world’s imminent end. In the present case, a majority of equity analysts do tout pharma’s growth prospects to their clients. But one of the more thoughtful people in that field, John Boris at Citigroup, does not necessarily share their across-the-board exuberance. His caution suggests that many equity analysts who cover pharma actually seek to protect their own jobs by hyping “the best house in a lousy neighborhood,” rather than describe things realistically.

While Boris believes a select number of specific companies are coaxing along a few auspicious compounds in their pipelines, he does not believe that most Big Cap Pharmas appear uniformly poised for growth. After attending a session where one of Wall Street’s most favored pharmas touted its pipeline, Boris wrote about his “concerns over its next wave of innovation.” In his assessment, “The next set of assets that they have are [sic] not enough to fill the gap.” The company’s “long-term sales and earnings growth is unsustainable,” while its biologic drugs unit, proclaimed with much fanfare by others, in Boris’ opinion will not meet a development target by next year. Overall, he characterizes the company as being “in an innovation hole right now.”

So while 2012 may hold some bright spots for pharma, it will also contain its share of setbacks and people who continue to act as if it was still 1994 or even 1984.

And what about the PR campaign that “gummint,” as George W. Bush used to call it, is pharma’s biggest obstacle? That is part of the same right-wing chant that maintains fear of future government regulation, not any lack of demand, deters companies from hiring workers. Last fall, the Economic Policy Institute published research that effectively debunked regulation anxiety as “a phony explanation for our jobs problem” (read this).

Nevertheless, the top 1 percent and their political henchmen, together with right-wing ideologues, keep blathering that the recession persists because employers maintain a free-floating anxiety about regulation. Purported fears of the FDA represent a similarly convenient bogeyman that pharma managements can blame when failures from their own, short-term thinking and exclusive self-regard become obvious.

So while pharma can’t acquire new knowledge of what it has already known for several years, some people adamantly refuse to learn important lessons, regardless of whether the facts are old or new. The hope for 2012 is that pharma will learn quickly and the lessons won’t be too costly.

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  1. Ed, this is the second blog you’ve published extensively quoting Dr Hoffman’s raging against the Big Pharma machine. You know us pharma guys well, and you know as well that we are big boys and can take a punch with the best of them. However, where I draw the line, and where I respectfully suggest you do likewise is Hoffman’s accusations comparing pharma’s misdeeds with the child rape scandal at Penn State University. Here is the link from Hoffman’s blog at the Philadelphis Inquirer.

    It’s your call as to whether you wish to continue furnishing Hoffman with the generous column width in the future.

    http://www.philly.com/philly/blogs/healthcare/What-Pharma-Can-Learn-From-Penn-State.html

  2. Hi OII,

    Thanks for the note and I appreciate your point. Over the past year, I have experimented with what I have called ‘op-ed’ contributions from guest writers. I’ve run several of these, including a few by Dan Hoffman. The topics have varied. But opinion pieces, of course, are designed to express specific views and generate some thought or discussion. It is in that spirit that I have run these.

    As to writings that appear elsewhere by contributors, well, I will attempt to take that into account in the future.

    Regards
    Ed

  3. Thanks, Ed. I do find it somewhat curious that Dr Hoffman, at least by his website runs a fairly conventional healthcare consulting practice, including pharma consulting, while at the same time blogging against some of the same categories of healthcare providers. Everyone is free to run their shop the way they see fit. Personally I would find it somewhat difficult to attract business from the very same clients who I am castigating in my columns. If Hoffman can pull it off more power to him.

  4. Hey there, OII, happy new year!

    Not sure if there is a feature on this site where you can track comments by the name of the person…? It would make it easier to get a *feel* for the overall consistency and viewpoint of the writer when it comes to certain discreet topics.

    So maybe you can help, OII - remember that exchange you and I had where you informed me that medical research was *dead*?

    Maybe you can review your posts on this blog and put together your own presentation about the same issue - *dead* medical research - as Mr. Hoffman writes about - that being what went wrong with medical research…

  5. dz, Happy New Year as well. You and I have a much harder job than Dr Hoffman. We have no crystal balls to predict whether our R&D designs (alive, dead or otherwise) will predict sucess. Dr Hoffman has the greatest instrument ever invented for critics of pharma R&D. It’s called the retrospectoscope. Like its first cousin the simoidoscope it can be inserted as far into any orifice as a critic, such as Dr Hoffman wishes to insert it. To use a stock market analagy, we in the R&D world live 24/7 in a “risk on” universe. Hoffman and his congeners live in a perpetual “risk off” universe, using the benefit of “hind” sight to insert their retroscope to the desired extent.

  6. Hi OII,

    A very belated reply to your earlier remark. I understand the issue you raised and while I can’t speak for Dan, I do know his Inky item, which you cited, tried to make the point that covering up mistakes is a dead end, as opposed to equating pharma with child molesters. Those are two very different things, of course, and I don’t believe his piece made that comparison.

    Beyond that, yes, he was in industry for many years and, as you noted, more recently in academia and consulting. I came to him, in fact, through my industry contacts and I know his opinions - however pointed - are valued and are actually meant to be constructive. We all know that being critical is not incompatible with offering useful advice and that’s what I’ve always taken away when speaking with Dan.

    Anyway, I hope this helps. At the end of the day, the op-ed is just that - an op-ed. I’m actually interested in trying more of these. The follow-up discussions can be interesting as well.

    Regards
    ed

    At the end of the day, the op-ed format

  7. What happened to medical research will not be a topic to go away:

    http://www.msnbc.msn.com/id/37560195/#45875919

  8. dz, you found a rare video of DR in a fairly stable, sober and serene moment. This is the other side of Ratigan that many of us in the business world know. CNBC dumped him for these kinds of immature ragings, and now he’s gone over to the Lefties at MSLSD, as my buddy Mark Levin calls them.

    http://www.youtube.com/watch?v=gIcqb9hHQ3E

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