Category: Pharmaceuticals

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Say hello to Hollywood

Derek Lowe writes about a great article in the February issue of The Scientist. The anonymous author discusses the flaws in the R&D model among major pharma companies and develops an interesting method of fixing them: Go Hollywood!

Big Pharma continues to follow the old studio model, though there are signs that this may be changing. A similar and necessary evolution to what Hollywood underwent in the 1950s may be beginning, with increasingly more drugs being discovered outside Big Pharma, presumably because the R&D process elsewhere is more conducive to creativity. Biotechs or small pharma settings tend to be flexible and nonhierarchical, with a tolerance for mistakes and constructive dissent — all characteristics of environments that nurture creativity and innovation. Consequently, the trend towards more drugs being discovered outside Big Pharma is likely to accelerate.

There is a precedent for pharma emulating Hollywood: Pharma’s main preoccupation, the creation of blockbusters, was directly copied from Hollywood. The blockbuster model is really defined by broad and aggressive marketing, though the term is less accurately, if more commonly, used to define revenue thresholds. Hollywood’s blockbuster model was created in 1951, when the term was first applied to the movie Quo Vadis because of its then-huge budget of $7 million and the unprecedented zeal of its promotion.

I know it sounds bizarre, and it may be dry subject matter, but this is a really compelling opinion piece, and I think laymen (like myself) can gain a lot of perspective from it on some of the problems with developing new drugs.

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Pfailed

What a difference two days make. On Nov. 30, Pfizer gave an “R&D open house” event where it discussed its drug pipeline. The biggest drug in that pipeline is torcetrapib, a compound that raises “good” cholesterol. For years, Pfizer’s been developing it as a combo-drug with Lipitor (atorvastatin), which reduces “bad” cholesterol.

Prior to the meeting, Pfizer issued a press statement that included this passage about torcetrapib:

Commenting on torcetrapib/atorvastatin (T/A), Dr. LaMattina said, “We are first-in-class and we intend to remain best-in-class in a category that has the potential to change the face of cardiovascular medicine. T/A raises HDL and lowers LDL. We believe that the net benefits of the drug — characterized by significant HDL elevation and LDL lowering vs. the small elevation in blood pressure — will greatly benefit patients with CV risk.

“The development of T/A has required tremendous innovation on our part from the earliest stages of discovery through one of the most cutting-edge development programs ever carried out anywhere. At the end of this comprehensive program, we expect to have a medicine with unparalleled efficacy in raising HDL, lowering LDL and with an anti-atherosclerosis indication.

“We will learn of the top-line results of the three pivotal imaging trials during the first quarter of 2007. During this same period, we will also receive the results of some additional Phase III lipid studies. To obtain a reliable picture of the overall safety and efficacy profile of T/A, the results of all these studies will need to be analyzed and reviewed together, and this will happen in the context of the American College of Cardiology Meeting in March, 2007.”

Yesterday, Pfizer announced that its independent Drug Safety Monitoring Board discovered a significantly higher mortality rate in the torcetrapib wing of late-stage clinical trials. The results must have been overwhelming, because Pfizer said that it’s stopping the trials, canceling all development of the drug, and accelerating its restructuring plans. A few days earlier, the company announced that it would lay off 2,400 sales reps, as part of its reorganization. Torcetrapib’s failure means large numbers of people will be getting fired in the next few weeks.

If you follow the pharma industry, you already understand what a cataclysmic event this is for Pfizer. I don’t think it’s on the scale of a Vioxx, because there’s likely no legal liability issues, but the lost sales will be in the tens of billions. Beyond that, there’s the opportunity cost of the R&D that was performed on the product, as well as nearly $800 million in actual development costs.

I’m not trying to convey a “poor little Pfizer” impression here; I disagree with a bunch of the company’s practices (particularly its growth-by-acquisition model from the first half of this decade). What I’m trying to get across is that developing new drugs is a mighty risky proposition. I’m not sure that people who complain, “Drugs are too expensive; pharma companies are evil,” have much idea about the risks and the costs these companies incur.

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It’s a Rap!

(You know you wanna check out the pix from my meanders in Toronto on Friday)

Home from Toronto a lot easier than my boss, whose flight home on Friday got cancelled due to “the airspace over Boston,” according to his pilot. He asked if this meant the bad weather & high winds we had all over the northeast, and was told that it did not. So, after 4 hours in an Embraer 145, he was allowed to leave and headed back to our hotel, where he sat in the bar and watched hockey.

Meanwhile, official VM buddy Sam and I went to see the Raptors play the Celtics in what Sam called “battle of the worst coaches in the NBA.” Since the Raptors have a game tonight against the Knicks, we figured maybe it’s a round-robin tournament.

We had fun at the game, but it was despite the action on the court. Sam’s now been to two NBA games with me (we hit a Dallas game against Orlando in April 2005), and he’s convinced I have NBA-Tourette’s, in which a constant stream of analysis & invective pours forth from my mouth during professional basketball games. We joined up with my boss after the game for a drink or two. He seemed pretty exhausted by the hurry-up-and-wait. I admit: if I were stuck in an Embraer for 4 hours, I’d probably go bananas.

Earlier in the day, after I visited Sam’s company in Oakville and toured the company’s produciton facilities (not as heavy-duty containment suiting as I wore on Thursday), I wandered around Toronto a little, while the weather was clear.

Unfortunately, this wandering didn’t coincide exactly with the clear weather, and I was stuck in some darned cold rain for a while. Early in my meander, I stopped at the Roots store in the Eaton Centre to get a hat and gloves. But then I decided that they were kinda pricey and, besides, the weather was okay now, so it would stay that way forever.

From there, I exited onto Yonge Street, which I forgot was an interesting amalgam of high-end retail, good record stores, and low-rent strip clubs. I headed off from there to a used bookstore I remembered from a past trip, but didn’t find anything.

I decided I’d walk through the University district and visit the famed comic store, The Beguiling. I spent a while there, hoping the weather would clear again and trying to justify spending $240 (Canadian) for a limited print by Sammy Harkham of a golem walking in the forest. I held off (I’ll wait till the USD appreciates against Canada’s dollar, and I’d probably be fine with a panel from The Poor Sailor anyway).

One of the nice things about having started doing yoga is that rambling ambles like this one don’t seem to give me the slight mid-back pain I was getting the past few years. I’ve only been on it for a few weeks or so, so hey.

During this walk, I came across two things I didn’t take pictures of: the Bata Shoe Museum and the Robarts Library. The former looks entertaining enough, and I bought a postcard from there for Amy, to give us yet another reason to take a long weekend here in the springtime.

The Library, on the other hand, is one of the most overwhelmingly depressing buildings I’ve ever seen. It may’ve been worse because of the rain and gray skies, but I can’t imagine a scenario which the appearance of this building inspires anything but fear and dread. Don’t let 1970s architecture happen to you!

After I left The Beguiling emptyhanded, it was time for another overpriced cab ride back to the hotel. I was amazed by the cost of cab rides in this city, as well as the ones I had to take to the pharma companies, which were outside the city. The flat-rate limo-y cars were also awfully expensive, including $51 CAD for the 20-minute ride from downtown to the airport.

In keeping with my recent post about accumulating all sorts of change and foreign currency, I returned home this morning with about $47 in Canadian bills and change. I feel like George Soros.

Anyway, a really neat thing happened during the short (54-minute) flight today. We completed our initial descent through the cloud cover, and all I could see were brown-gray hills and a few houses and a winding road or two. I thought, “We’re only 15 minutes from landing, but I have NO idea where we are right now.” It looked like Pennsylvania farmland, or far western NJ.

Then I noticed the Sheraton Crossroads to port, and it hit me: I was looking down at my morning commute! Sure enough, Rt. 17 threaded away from the Sheraton, southeast to Ramsey. Our plane followed Rt. 208 for a bit, as I picked out landmark after landmark (the Nabisco plant, the Ikea across from Garden State Plaza, even the Lukoil I stopped in last week). I’ve only had this perspective from a plane once before. Usually, I come home at night, or on different flight paths.

It helps to see things from different angles. Except Raptors/Celtics games.

(check out a couple of pix from my Toronto walkabout)

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Containment Policy

I spent a chunk of the day wearing containment gear during a visit to a drug manufacturing facility near Toronto. Unfortunately, I had to sign a confidentiality agreement before the visit, so there was no way to take photos of myself in this amazing get-up.

My guide for this tour told me that the facility’s policies are for redundant safeguards against contamination (there’s some high potency materials in this site), so we were overdoing it for the sake of added safety. Even so, we didn’t enter any of the production suites where the material actually gets handled; the staff in those rooms wear full rebreather gear on a daily basis.

So, as you can tell, I’ve started another trip. This one’s pretty brief: I’ll be visiting one more drug manufacturer tomorrow, then hitting the Raptors/Celtics game with my contact at that company, official VM buddy Sam Ricchezza, last seen writing the Raptors report in our NBA preview, and goofing on me for not coming up to visit him and see his company.

Right about now, I’m hitting up the minibar for a caffeine fix. I’m also eyeing the pod-coffee machine pretty suspiciously, but it might be necessary to keep me awake till dinner, which we’ll be having at Rain, which “was once the site of Toronto’s first women’s prison,” according to the site.

Anyway, I took Shakespeare Wars with me (hardcoveritude be damned!), and have enjoyed the first 50+ pages. I’ve also got my Yoga for Regular Guys with me, since I’m trying to make a habit/practice of that. The weather’s pretty grotesque, so I doubt I’ll be able to take any good pictures. It’s a pity, since Toronto’s a kinda neat city. It’s my 3rd trip here, and it’s always struck me as a pretty good place to be. Admittedly, I know nothing about the economics of the place.

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All Along the Watchtower

I admit that I’m a little compulsive about checking traffic on my site. It’s not a very significant number, but it helps me feel a little wanted, and sometimes I can figure out if old friends or recent acquaintances are checking up on this blog, via the IP address and other info that SiteMeter shows me. Usually, I can see if the user was referred to my site by an external link, or a search engine. Lately, a lot of people have gotten here by searching for images of Giada De Laurentiis. Some stay a while. It’s a funny world.

This morning, something strange happened. I noticed a significant bump in traffic: about 30 people or so had checked in before 8 in the morning. I decided to look into the details, and discovered that nearly all of them were from the far east, and they were all going directly to a single post of mine, Moon over Malaysia.

Longtime readers who remember too much for their own good may recall this post. It was about how the Malaysian Biotechnology Corp. wanted me to stop by for an interview during the BIO conference in Chicago last April. When I looked up the country’s official policies toward Israel (“it doesn’t exist”), I declined the invite, writing a polite note to the PR rep in New York who was trying to arrange the meeting. I never heard back from them. It’s all in the post.

This morning, and late last night, and all throughout today, I kept receiving hits to that exact post. What was particularly interesting (or scary) was that not a single one of those hits included a “referring URL.” That is, there wasn’t a link on another site that led all these people to my site.

As far as I know, this means that they either all got the link via e-mail (but not a web-based e-mail like Gmail or Yahoo!, which would have left a referring URL), or there’s some site out there that linked to my post and is, um, secret enough not to leave a trace on SiteMeter. And it has users in the following locations:

    Petaling Jaya, Malaysia

    Tanjong Tokong, Malaysia

    Bilit, Malaysia

    Kampong Sinempuan, Malaysia

    Kampong Abu Bakar, Malaysia

    Kuala Lumpur, Malaysia

    Kampong Tepi Sungai, Malaysia

    Sungai Besi, Malaysia

    Val D’Or, Malaysia

    Alexandria, Egypt

    Dakar, Singapore

    Coatbridge, UK

    Hull, UK

    Sheffield, UK

    Cardiff, Wales

    Berlin, Germany

    Perth, Australia

    Melbourne, Australia

    Toyama, Japan

    Sterling Heights, Michigan

    Garden City, NY (the user was on a computer at Adelphi University, alma mater of Baba Booey)

Some of these people stayed for only a second, while others hung on for a while or moved around on this blog. No one left a comment.

It was a little troubling, I admit. Fortunately, when I got home tonight, I received some reassurance.

It seems that, while the Malaysians were creeping around my site, the Jehovah’s Witnesses were busy driving through my neighborhood. They left a flyer in my door proclaiming “The End of False Religion Is Near!” So, y’know, I got that going for me. . .

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We got hats now!

For years, one of my favorite trade-show goodie-scores was a baseball cap from the legal firm of Morrison & Foerster, because it featured the company’s abbreviated name: mofo.

I lost the hat during my drive down the Pacific Coast Highway in a convertible in 2004, heading from San Fran to San Diego. I was peeved, especially because I lost the hat a moment after passing a warning sign about high winds.

Now, at last, I have a replacement. And it’s all thanks to the architectural firm of Hooker and Cockram.

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Decisions, decisions

While the rest of America has to make up its mind about which way to vote tomorrow, I have to figure out if I want to spend $100 for a ticket to an Orlando Magic game, then spend $100 on cab fare to and from the arena, since I’m currently in the Disney Protectorate of Lake Buena Vista.

Which is to say, it’s not looking good, dear readers.

Fortunately, I found a bar that serves some high-end gin. So I have options, is all I’m saying.

Becaues we’re in Mauschwitz, the keynote address for our conference was a 45-minute presentation by a representative from the Disney Institute. He discussed innovation issues, and how what Disney does can translate into practices for the healthcare industry.

Which means, I guess, that drug companies should “lobby” members of congress into extending drug-patents indefinitely into the future, the way Disney has done with the copyright for Mickey Mouse. That’s innovation!