A History of Lean and Mean Regulatory Medical Writing




Danny Benau, Director, Biomedical Writing Program, University of the Sciences in Philadelphia, joins Andrea Charles from Pharma IQ, to discuss the evolution in the pharmaceutical job landscape. 

Pharma IQ: So, Dan, we've seen great innovation in the pharmaceutical industry.  How do you think that's impacted on the career ladder for pharma professionals?

Danny Benau: I started... actually I'll give you the actual date. December 16th 1990 was my first day in pharma.  Before that I'd had an 18-year education and career in bench biochemistry.  I came in as a medical writer, to Wyeth.  At the time, computers were primitive things. The use of mice was unheard of.  Graphical user interfaces were on Macintosh's, which if you wanted to use them you had to smuggle in because IT hated them, still does.  Well, they're stuck with them now with iPads and iPhones. 

Things were transitioning from handwriting your documents and giving them to the word processing staff to type up, to typing your own stuff on a computer and then having some reviewers or other take it from there and edit it.  The technology has changed.  It's faster to do it.  The writing task is certainly simplified by the use of technology, but still, certainly in the regulatory writing field, there's still the idea of lean and mean writing, combining with data and making sure that the data are clear and that the pointers to data area clear. 

Regulatory reviewers really fall into two classes, those who actually read things like clinical study reports and those who just... at least in the FDA, and those who just want the data.  And Europe's a little different.  Europe has always been a little bit more academic in their approach and so they tend to read more of what you write. 

Pharma IQ: Why do you think that is, that Europe has a slightly different approach?

Danny Benau: That's culture, very much so.  The scholastic approach really changed I think after the FDA... after the act-up riots in Washington in the late 80s.  It used to take two to sometimes four years after submission of an NDA to get approval.  And of course at the time, with AIDS raging, the act-up demonstrations were about while you sit on your butts you're killing people. 

So there were two things, one well known, one less well known.  The well known, of course, was to do with the Prescription Drug Users Fee Act.  This was one of the major milestones of the change in pharmaceutical application view in its attacks.  I mean, it's funny.  I've seen some people talk about it as bribery of the FDA, but it's only bribery if anybody personally benefits, and nobody does. Money is used to hire reviewers, to improve technology and to speed up review. 

One of the less-celebrated things that happened around the same time was the formation of the no-longer-existing Pilot Drug Group.  Actually they came out of I think the analgesics and anaesthetics group in the FDA.  And they basically explored a project management rather than a scholastic approach.  The head of that group was John Harder, the late John Harder.  It was actually, looking back, a brilliant idea.  At the time, having had to work with them, since the field I was working in was anti-inflammatories, you could find yourself feeling like you were chewing glass because they were doing things very differently than the FDA had done before.

There is a write-up on the Pilot Drug years on the internet, coming out of the John F Kennedy School of Governance, from Harvard, although the guy who wrote that was really interested. One of the things Pilot Drug was tasked with was doing the final analysis on LSD, pot and some of the other so-called recreational drugs.  There were INDs out on them.  But the main contribution - and, as I say, it's actually worthwhile looking it up if it's still online, it has been a number of years, because really what Harder did was he explored two things, project management and applying project management rules to the evaluation of pharmaceuticals and to get rid of what was essentially a two, two and a half-year backlog - was the increasing use of refusals to file. 

The first thing they did was they went through and they looked through a bunch of submissions and said, this is a dead duck, this is never going anywhere, why should we waste our time, you know, when there are other more promising submissions that we can view?  And while there was, sort of, a bad end to it because it went about a step too far - they started inventing their own statistics and doing a few other things, and I don't really want to get into that - it still had a major contribution to the way people thought and the way things were done and it, kind of, marked the transition from consumer safety really to project management. 

So as a project model I think it's an important milestone, and I don't think you'll find it written up in many places.  I think you'll find it under appreciated, but it was a critical event.

I once spent a summer with a statistician just doing format samples for submission, over and over and over again - I think we submitted about 15 of them - because they had felt that the study was overpowered.  Power is a very important concept in submissions.  You know, how many patients do you analyse per group?  The idea being that if you're overpowered, the smallest maybe not clinically relevant change will still show statistically significant change.  So they were exploring ways to find out if there are ways to control an overpowered studyand still come up with a valid conclusion.  It was a very interesting approach.  I don't know if they do it anymore. 

But we actually... my statistician colleague and I ended up inventing ways to get these things done, some of which is routine now, which was the inclusion of creating automatically downloadable table formats.  In the old days, they used to wheel a hand truck of green bar paper write off, print off, every time you were doing a clinical study report, an NDA, anything like that.  We really explored just pulling it off online and getting it into a form that you could plonk it right into a Word document and have it show up as a table.  These days, everybody does it.  Those days, it was like, huh?

Pharma IQ: So you were one of the first then?

Danny Benau: We were early adopters, shall we say.  The guy I worked with is now, I believe, Head of Programming at Amgen.

Pharma IQ: And what would be your, sort of, top-three tips for successfully building a medical writing and editing career?

Danny Benau:  They won't train you anymore.  That's one of the big changes in the other direction.  Back in the early 90s you fell into clinical research. There were no classes really in the early 90s.  Even the programme that I'm director of now - I'm the fourth director of that programme - we seem to last every four years or so.  But it didn't start 'til the late 90s.  Its first class was in 1998.  And the various clinical research programmes, degree-granting and certificate-granting programmes, really took off around the turn of the 21st Century. 

Before that, the pharmaceutical companies trained their own.  Wyeth was a great place to do that because they didn't pay very well but they were, kind of, easy to get into and a lot of people clambered to Wyeth-trained personnel.  As time has gone on, they discovered that, A, it's expensive to continue to train people, B, it's both cheaper and competitionally better to steal the other guy's experienced people, but there's a limited pool of that.  I mean, people retire, people die, people change industries. 

So ultimately, clinical research is now going more toward... I got an education and a degree in it and I'm willing to start... and that's essentially the equivalent of, say, the Master's level, we feel, of about two years of experience under the old system, because you're taught about stuff that you only learned as you went; the difference between a serious and a severe adverse event, one having a legal definition, the other being merely a clinical opinion; the difference between the various flavours in medical writing. 

When I first started I was doing clinical study reports, I was doing publications.  I never did continuing Med Ed, but a few of my colleagues did slide packs and stuff.  As the 90s wore on, those became specialities and the pub houses really branched off into one or the other.  I had one other full-time colleague in my programme, and she's a non-regulatory writer, says, it's the perfect split.  I'm regulatory; she's everything else.  But one thing is that if you're a real medical writer you're not a marketing writer.  Copywriters are a whole different breed under a whole different set of rules.

Pharma IQ: Do you find any of the students on your programme are worried about job security in pharma?


Danny Benau: Of course. They all are.

Pharma IQ: And what advice do you give to them as a result of that?

Danny Benau: I've actually put up a sort of a chart. I mean, the biggest worry, of course, is always off-shoring, okay.  For instance, clinical data management, in other words database management, is almost pretty much all moved to India.  There's no language barrier to that.  There's no culture barrier to that.  The safest jobs are the ones that involve the most culture and the closest language to the regulatory or other audience that you're dealing with. 

So in cases of writing, regulatory writing still is handled most successfully in the US.  Even though you may no longer find that work in a large company, in a large sponsor, like Pfizer or Glaxo or whoever, you will find contract research organisations that have strong writing groups or groups that tend to hire freelancers and are strong coordinated writing groups.  And that's true for a lot of the other functions as well, okay.  It's very hard to do project management at long range.  It's just the nature of the beast.

On the other side of the coin, programming, database management, numerical stuff is culture independent and pretty much language independent, up to a point ,of course.  If you're going to validate programmes you're still, kind of, stuck with, the English type of programming statements as opposed to other languages just because it's, again, a matter of origin and the culture of programming, but that's easily picked up overseas. So those are the least certain career paths.

Pharma IQ: And what advice would you give to an inspiring young person wishing to embark on a career in pharma?

Danny Benau: Network like hell, okay.  Monster and all the electronic stuff, black hole.  Your stuff goes in and if you don't match what they want it just gets spit out.  In the old days, HR was your friend.  We have so and so many people to recruit.  These days, HR is your enemy.  We have so and so many people to eliminate.  SHRM will not like me saying that, SHRM being the Society of Human Resources Management, but it's true.  That 80, I think that's a conservative figure  80% of the good jobs come from networking, and that's one of the things that makes DIA valuable.  This is a strong networking centre.  For writers, there's also the American Medical Writers Association.  For a medical editor there's International Editors.  There's also EMWA, the European Medical Writers Association. 

So if you're not joining these networking groups and going to the functions, if you're just trying to sit and read stuff online, you're going to run into trouble.  You're not going to get very far and be real luck... You're always better off using your own communication.  Doors can shut very easily, but there are more windows than doors.

Pharma IQ: More windows than doors. I like that.  So you've basically got through the window.  What would be your, sort of, top tip for preparing for that all-important interview?

Danny Benau: Top tip?  Be professional, okay.  Relax your way into it.  Realise that the pharma industry is... well, they're not bankers and lawyers and three-piece suits may not get you very far, depending on what job you are going for..if you're going into sales you'd better be wearing a suit or finance. 

But it's still very important not to be too casual and to make sure that you do your homework, absolutely know what that company does, absolutely know what that company's culture is based on.  Company cultures are a critical thing, and that's one of the things you want to keep your eyes open, because the fact of it is the worst thing in the world is going in with a cultural mismatch.  If your mindset and the hiring company's mindset differ dramatically you're in for a very miserable year before you're spit out.  I've seen that happen time and again.

On the other hand, if you do your homework, you, with luck, know maybe one or two people who are already in there.  When you interview, be sure to ask questions as well as answer them and include things like what are the life balances?  What is expected in terms of fitting into the company, not just the subject matter competencies, but also the soft skills?  Soft skills are so critical that's the one thing that's terribly ignored in graduate in scholastic programmes, the ability to relax, don't to be hanging at the edge of your seat in an interview, the ability to answer questions, even the off-the-walls ones, and there are some real off-the-wall questions. 

My favourite one has always been, you know, like, if you were a tree, what kind of a tree would you be?  And I think that happened to me once and I've known other people that happened to.  And it was at the end of an interview with me and I just said I would be poetry.  That way everything would be poetic justice.  But they're not looking, for that kind of thing, for real answers, they're looking if you can think on your feet.  Okay.  So be relaxed, be prepared and don't be rigid. 

But generally, if you found the interviewing opportunity through networking you've already got a leg up.  If you're networking right and you've done your homework about the company, critical.  Don't walk in there not knowing your company, the company you're interviewing at.  These days, online, with what they have to post online, you'd be a fool not to.  But also, read their quarterly post... financial postings, read their annual report, and you'll get a feel for what this company does and what this company considers important.

It's amazing when you're not a finance person how easy it is to ignore that and yet if you go in there as a non-finance person and you know what are the company's strengths and weaknesses, what its pipeline is, are there any consent decrees that they're dealing off of, anything like that... Don't bring that up, per se, because, you know, right away you'll come off as hostile, but if you know that it's a concern, be prepared, they may ask you something about what would you do to avoid having this happen.  If you know that that's going on you know where it's coming from. So preparation is a big key.

Pharma IQ: Just to move to a slightly off track, what three or even two regulations do you think will have the most impact in the pharmaceutical industry in late 2011, early 2012?

Danny Benau: Obviously in the United States it's going to be the healthcare reform.  Do they call it healthcare reform?  I'm not sure if that's a misnomer or not, but whatever it is, that's going to be it because that's going to affect a lot of the coverage, how pharmaceutical peers work.  And that's going to take an awful lot. 

The other thing, oddly enough, is going to be watch out for the DDMAC stuff - that's the Division of Drug Marketing Advertising and Communication - because they're the ones that determine what you can and cannot say as an industry.  And, for instance, just to show you how it may be subtle but powerful, you won't go into a doctor's office and find a pen with a drug name or a drug company name on it anymore.  That's just FDA and the Pharmaceutical Research and Manufacturers Association have both banned it. 

If you go to, say, a professional society meeting, not Drug Information Association, but let's say... I'm reporting from my colleague.  She went last year - it was the first year this was in force - to the Sleep meeting that was held in Seattle.  That's her therapeutic area, central nervous system and sleep.  Since they could no longer hand out what they call catchgers, you know, pens and cups and other stuff with drug names on it, she said every single exhibitor on the exhibitor's floor had a little oven and was baking cookies.  She said the place smelled like a bakery.

So this kind of stuff, which, frankly, personally, I feel is based on some fairly rotten research.  Sorry, I'm a lifelong researcher.  I mean, 18 years at the bench and now doing, you know, other types of research and qualitative research and stuff.  I was not impressed with the research that that particular ban was based on.  But that kind of stuff, which is actually politically based or a politically correctness based thing is going to certainly have an effect on pharma down the line. 

You have to realise that for the moment. I would say pharma has never been popular, but these days it has a kind of a hyena reputation, and it's going to take a while and a few good therapy-changing drugs to change that reputation again.  It was back to smelling like roses during the... when the Statins came out and suddenly you can control cholesterol, life spans were lengthened, but even though there's little direct evidence, a lot of it stems from that time and those drugs.  Then we got all look at the marketing, you know, look at the sales.  You know, well, great, you can say that.  The fact of it is it's an awful lot cheaper to take pills than to have somebody slice you up.

Pharma IQ:  And, Dan, finally, if you could have had any other career, what would it have been?

Danny Benau: Good question.  Don't forget I came out of scholarly research, and my doctorate's in biology and my specialty was biochemistry of reproduction.  So I suppose if I hadn't answered an electronic ad. This was new at the time.  There was no Monster, there was no internet. I answered an electronic ad in Prodigy], which was a big thing at the time.  It was the predecessor to America Online, which of course is dead in its own right now. 

But they were trying something brand new, an electronics job board.  And I was just finishing up my post doctoral work in carbohydrate chemistry actually and I didn't want to move to California, which is where all my offers were coming from.  No insult meant to California, just that I didn't want to change coasts, not at that time.  And Prodigy had an advertisement for Wyeth that said, do you have a PhD in life sciences, published a couple papers?  Come see us.  Maybe you want to be a medical writer.  So I stopped being a bench scientist and I came to see them, and it certainly didn't hurt that they were in Radnor and so was I.  I stayed there ten years.  You'll do an awful lot for a ten-minute commute.

IQPC

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