Utilitarianism

Every summer, when we get rolling on the annual Top 20 Pharma / Top 10 Biopharma report, my trusty associate editor compiles pipeline information for the past year. While I suss out sales figures and try to parse the arcana of accounting, she puts together lists of new drugs that were approved, extensions or new indications for approved drugs, those that are filed and pending approval, those that have lost patent protection, research projects in late-phase or early-phase studies, and those that were canceled or rejected.

That last category, the could-have-beens, is a testament to the enormous risk that drug companies take on. This year’s #1 company, Pfizer, recently had to cancel development of a drug that would have brought in upwards of $50 billion in revenues during its lifecycle. Future revenues are kaput and $1 billion in R&D investment has been flushed away with it.

Fortunately, Michael Moore has a strategy for eliminating this expense and the risk! America needs to regulate drug companies “like utilities since they’re just as important as electricity and water.” That’ll make them more productive and less expensive! Of course!

I mean, outside of the fact that the U.S. power grid is antiquated and prone to collapse, and that the water supply in this house was provided by a well for 35 years, I’d have to say he almost knows what he’s talking about.

I do find it funny when people tell me the pharma industry needs more regulation, and that drugs should be cheaper.

Brand Unawareness, Part 2

“Gentlemen, our target market is. . . young people who don’t bother paying their bills!

Apparently, those free-spending youths don’t care much for paying their cell-phone bills. A court motion filed on June 4 explains that Amp’d “experienced an unprecedented growth of subscribers” between November, 2006, and February after running ads on MTV about the wireless phone company’s lineup of mobile music and video content.

Collecting payments from these subscribers proved to be a challenge, however. “Approximately 90% of the debtor’s customers were on 18-month service contracts,” according to the filing. “The debtor began to find a host of credit and collections problems (that) contributed ultimately to a liquidity crisis.” By May, the number of nonpaying customers reached 80,000. That’s nearly half of Amp’d’s current customer base of 175,000 subscribers.

Funnily enough, the writer doesn’t quite the grok the contradiction in the following statement:

Here’s why Verizon may want to pick up Amp’d on the cheap: Amp’d has been exceptionally successful in getting its subscribers to use data services, which are expected to become the wireless industry’s growth engine in the coming years. In the first quarter of 2007, Amp’d users downloaded twice as many videos, songs, and games as in the fourth quarter of 2006.

Which sounds great, except their customers didn’t bother paying their bills!

Cowtown

Those of you who have come out to Stately VM Estates may think that Amy & I live out in the sticks. I go to some lengths to point out that, no matter how isolated my town is, it’s nowhere near as bad as the next town over, West Milford. And now I have proof.

No horse in this race

Here’s a neat article about how wine overtook beer in America:

Meanwhile, the American middle classes have fast become connoisseurs of everything — coffee, ’80s Japanese garage-rock bands, environmentalist toilet paper. Now, Americans who want the exclusivity that connoisseurship offers but didn’t want to seem like snobs can have it both ways. Beer’s approachability became less of a virtue. Ironically, in the ultimate about-face, craft-brew drinkers lifted the language of wine. (Tasting notes for a pale ale from the Web site BeerAdvocate: “Nose is floral, like orange blossoms, with some citric rind and soft apple.”)

As someone who refers to himself as a “gin snob” (among other examples of my snobbishness), I can see what he means.

So, are you more of a wine drinker or a beer drinker? (excluded from this question: my teetotaling family and my recovering alcoholic exes)

Publish and perish

Here’s an article about how Perseus Books Group is closing down two of its imprints: Carroll & Graf and Thunder’s Mouth Press. The further away I get from my indie-publishing days, the less I can understand how any of them stay afloat. This passage summed up how I tried to see things back then:

“When you see the book world conglomeratizing, it can only mean less diversity of voices,” said Johnny Temple, publisher of Akashic Books, a Brooklyn-based imprint distributed by Perseus. “When I sign up a book, it matters more that I love it than that I’ve identified a good marketing niche for it. That’s the real essence of independent publishing — it’s not a deal, it’s supposed to be a labor of love.”

Then I lost the love.

I hope the founders of those presses got a decent purchase price when they joined up with Avalon Publishing (which was later acquired by Perseus), but I have a feeling that I can see where the “labor of love” part collided with the “good marketing niche” part:

“At Carroll & Graf, we bridged the gap between small, lesser-known presses and the larger houses when it comes to gay literature,” said Don Weise, a senior editor who is losing his job. “In the four years that I’ve been here, I’ve acquired more than 100 books, and no one has ever told me no, I couldn’t do that. In the book world, that’s unheard of.”

I probably would’ve moved his attribution, along with the “senior editor who is losing his job” part to the end of the paragraph, to make my point.

Regulatory Overkill?

[Excerpted from this month’s From the Editor column at my magazine.]

In last June’s From the Editor page, I wrote about a scandal involving Chinese “innovation,” namely a rip-off that literally involved scraping a western company’s name off of cell-phone chips and painting a Chinese company’s name on them. I received some guff for that editorial, and have been told at numerous conferences in the past year that China will dominate the 21st century, because the world is bowl-shaped or flat or somesuch.

I maintain that the country’s poverty-level population (800 million), out-of-balance birthrates (in the 1990s, some provinces peaked at 32 male births to one female, thanks to advances in portable sonograms), and catastrophic environmental record are going to yield so much unrest as to counter its “economic miracle.” Those of you who’ve had the misfortune of listening to me expound on this subject know that I believe China’s one-party dictatorship makes it impossible for the nation to truly accommodate itself to the western world; instead, it does a passable impression of capitalism. But when it breaks down, it breaks down critically.

Let’s take China’s role in exporting chemicals, a major economic driver. Those exports have made plenty of news lately, after

  1. an ingredient (or two) used by Chinese livestock-food suppliers to falsify protein tests led to the deaths of a number of pets in the U.S., and
  2. a counterfeit ingredient in cough syrup supplied by a Chinese company poisoned at least 100 people n Panama.

These problems don’t only plague China’s exports; the same ingredients have led to deaths within China, too. Perhaps we should envision these as growing pains, a result of China’s crash course in modernizing the SFDA and bringing its drug supply under regulation. If anything, that would mark these events as symptoms of the country’s attempt to join the international community.

That reading might be a valid one, given that the toxic ingredient in the cough syrup happened to be diethylene glycol. After all, the Food, Drug and Cosmetic Act was passed in the U.S. in 1938 after the use of diethylene glycol in “Elixir Sulfanilimide” led to the deaths of more than 100 Americans.

Seventy years ago, there was no requirement for tox-tests for drug formulations. The manufacturer’s lab tested for flavor, appearance and smell, but not toxicity. So this elixir shipped, and the death followed. At the time, the agency was simply fortunate that the product was called an “elixir.” According to an FDA article, if it had been called a “solution” instead, “FDA would have had no legal authority to ensure the recovery of the drug and many more people probably would have died.” As it was, agents had to fan out across the country to help in the recall of the elixir. All told, 234 out of 240 gallons of the toxic product were recovered.

Following the diethylene glycol disaster, the FDA was given greater authority to regulate drugs, and evolved into the agency we know today, for better and worse.

Nowadays, we hold congressional hearings about tougher standards for Advisory Committees. Concerned about conflicts of interest, our representatives debate regulations stipulating that no one who is an expert enough about a subject to get paid for it should be responsible for evaluating it. (Hey, it’s my reductio and I’ll ad absurdam if I want to.)

As it turns out, China — and that one-party system of theirs — has also developed new regulations to deter conflicts of interest. In their case, a court recently ordered the execution of the former head of the SFDA.

In May, Zheng Xiaoyu was convicted of taking more than $832,000 in bribes in cash and gifts during his tenure. According to a state newspaper, “Under his watch, six types of medicine approved were fake and pharmaceutical companies got away with using false documents to apply for approvals.” Oh, and an antibiotic produced under not-so-aseptic conditions looks to have killed at least 10 Chinese patients.

The government has already taken the occasion of the sentencing to announce a new food-recall system; we’ll see how it overhauls the drug process. I’m all for creative destruction, but I’m hoping it won’t take too many more of these episodes before we see China adopt some semblance of global standards. I’m not optimistic about this, of course.

Fortunately for Mr. Xiaoyu, if the method of execution is lethal injection, then there’s always a chance he’ll come out of this experience just fine.