Category: Pharmaceuticals

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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.

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Cause? Effect?

According to ESPN.com, Ricky Williams tested positive for pot again. Obviously, that’s not news. The only reason I’m posting about it is because of this unintentionally funny paragraph from the story:

“Falling off the wagon is part of rehab,” a source said. “Based on the medical evidence in Ricky’s case, the doctors say it’s too early to come back. He had the positive test last month. Remember, he’s been diagnosed with social anxiety disorder — that’s a real disease and a good percentage of those folks self-medicate with substances like marijuana, often at the moment they are about to have a high level of social interaction.”

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The Epically Boring Boston/BIO Post

The trip to Boston for the BIO show was productive; I made some good editorial contacts, was praised for the quality of our magazine, ate at some fine restaurants, and saw a bartender mix a drink with liquid nitrogen. Here’s a slideshow of my BIO pix, and another of my non-BIO Boston pix (including the aforementioned drink).

For the first time, the conference organizers forgot to put me on the press list (we exhibit at the show but, since we’re there as a magazine, I usually end up on the press list), which meant that I didn’t have 10,000 appointments lined up. At least half of these tend to be for

  1. economic development regions that don’t have any industries that overlap with what we cover, and
  2. companies that provide services or components that don’t overlap with what we cover.

So the exhibit hours were less stressful than usual. Sometimes it’s tough for me to keep the “that’s VERY interesting!” vibe going when someone’s discussing an innovative chromatography column. (I’m sure these columns are VERY interesting, but I’m not a scientist, so hey.) Similarly, when a region hits me up for editorial coverage, and I discover that it has zero pharma-manufacturing business, I have to break out the “I really wish we had more coverage of, um, translational genomics, but that’s not really our bailiwick” stuff.

Anyway, the night before the BIO began, my friends Paul & Deb came up from Providence. We meandered along the Liberty Trail for a bit, checked out some Brutarian architecture, then headed over to our restaurant in Quincy Market / Faneuil Hall. Unfortunately, the BIO reception was taking place in the area, so the whole place was under lockdown. We had to wait at a checkpoint, then got handed off to 4 different security guards as we closed in on Wagamama. But the meal was worth it. And our attempt at circumnavigating the security cordon gave us the opportunity to see an Elvis-on-stilts handing out giant sunglasses and plastic Elvis toupees.

As I noted in my Montaigne post on Monday, I got a terrible night’s sleep Sunday, due to a 3-second “bzz!” that occurred every 4 or 5 minutes. All night. I got it taken care of on Monday night, when an engineer came up to the room. He fiddled with the AC for a few minutes, even though I told him it hadn’t been on the night before. Then he heard the “bzz!”, realized it was something in the restaurant upstairs, and ran out to take care of it. No more noise = full night’s sleep.

I knew I would need plenty of caffeine to make it through the exhibit hours Monday, and this sort of conference always has plenty of exhibitors who have baristas making all sorts of coffee. I got by on that during the morning, but true salvation arrived when I began to venture out through the exhibit hall.

See, I may not be a detective, but certain details leap out at me. When I passed an empty booth-space and noticed a Tim Hortons cup sitting on a table, my sleep-dulled mind leapt into action! I knew it could only mean one of two things:

  1. an exhibitor or attendee picked up some Timmy’s from one of the New England outlets, brought it into the show, and discarded it here, or
  2. the Canada pavilion was serving up the best coffee around.

I looked above for the Canada banner, spotted it near the front of the hall, and headed over to the pavilion. I was expecting to find an exhibitor with a little Tim Horton coffee urn or somesuch, but found a full-service coffee-stand, replete with donuts and other insanely good pastries! Not wanting to spoil the client dinner ahead, I only grabbed a coffee. I went back to our booth and told my publisher about the place. He ran out with our dinner guests, and they all returned with donuts, pastries and coffee at 3 in the afternoon.

I was happy, knowing that my breakfast plans for Tuesday were now solidified: blow off the hotel fare and score some of that Timmy’s.

After the first day of the show ended, we took those clients to a great restaurant in the Eliot Hotel in Back Bay: Clio. My publisher & I arrived first and sat at the bar. I was cheered to see a bottle of Hendrick’s (even though I was hoping for Miller’s), and ordered a G&T. Gary ordered a mojito and then asked the bartender what the signature drink was. The bartender proceeded to open up a local magazine and pointed to an inset in a Q&A. It described the Screaming Ginger, which is made with an exotic vodka, green tea, ginger . . . and liquid nitrogen.

Now, I don’t know that it was really liquid nitrogen in the container, but I do know that it froze everything else in the glass instantly (he poured it in first, before adding the other mixed parts), and emitted so much steam that it looked like one of Grandpa Munster’s experiments. How do we know? Because Gary ordered one after his mojito:

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The bartender, Theo Ford (we asked him for his name in case I decide to include that pic in the BIO wrap-up in the June issue), took out a toothpick to poke the ice at the top of the glass and keep it all from freezing over. The result was a sort of slush/sorbet texture, with a little kick and a nice, subtle green tea taste.

Well, I had to try it! It’s the BIO show! You’ve gotta play with chemistry!

Dinner was fantastic: tuna & salmon appetizer, and two lobster tails for the main course. Gary suffered his usual fate of receiving the smallest portion of anyone at the table who had that order. We’re convinced that waiters think he’s a fat load and do this to him out of the goodness of their hearts. My dessert was a melting chocolate dish, but my neighbor’s was funnier. He & I were bonding over music and The 40-Year-Old Virgin all evening, so we did plenty of goofing on/with his dessert:

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And that was pretty much the night. I got back to my room, fell asleep by 10, and was all bright-eyed and bushy-tailed for the second day of the conference. There’s little to say about that day, except that I subsisted entirely on coffee, apple fritters and maple & pecan danishes from Tim Horton, which I would come to regret. Oh, and the Nebraska pavilion, directly across from our booth, started grilling steaks at 10 a.m., which is a kinda weird time to start smelling steak. That lasted till 5 p.m.

Tuesday night’s dinner was at a fantastic restaurant, Number 9 Park, but was marred because our clients canceled on us at the last minute. Like, “when we were heading there in a cab we got the call from them” last minute. Still, we do as needs must when the devil drives.

(Speaking of which, Boston has the most talkative cab-drivers I’ve ever encountered, hands down. Except for my Wednesday ride to the convention center, every cab ride involved non-stop chatter from the driver. And it’s one thing when the passenger can just grunt to hold up his end of the conversation, but when the driver starts asking essay questions? Please: Get back on your cell phone and complain in a foreign language. And it turns out I wasn’t the only one to notice this; my coworkers and other attendees all made comments about the gabby cabbies.)

Once again, Gary & I reached the site early and parked ourselves at the bar. This time, I was got my Miller’s G&T, which made me a happy boy. Appetizer (no pix in a joint this classy) was Seared La Belle Farms Foie Gras (muscat grape salad, yogurt, candied walnuts), and entree was . . . Slow Cooked Pork Belly (consomme, radishes, braised leeks), because I’m bold like that. And I don’t keep kosher.

My coworkers were scared of my dinner choice, although two of them gave it a shot and admitted that it beat their duck pretty handily. For my part, I said, “How could I look my wife in the eye and tell her that I didn’t try pork belly in a restaurant as fine as this one?”

What followed dinner was a surefire sign of the apocalypse: I was able to find my way back to our hotel on foot. Now, this isn’t a joke about being drunk during a business trip. No, it’s about how Boston is the least sensical city I’ve ever visited. I have never failed to get lost during my trips there, and even when I knew the general direction back to Faneuil Hall, I was convinced that I’d turn a corner at some point and see a sign that read, “Welcome to New Hampshire.”

So it was pretty scary that I was able to manage that walk back from Boston Common. I’m sure the Bostonians in the audience are sneering over my pride at negotiating this short distance, but the absence of a grid is totally disorienting to someone whose idea of a city is Manhattan.

Once again, that was pretty much the night. I got back to my room, fell asleep by 10:30, and was all bright-eyed and bushy-tailed for the last day of the conference.

It was beyond uneventful, except for really esoteric stuff about my magazine. No good anecdotes to share from the show floor, and the Nebraska pavilion was out of steaks (they sent 3 days’ worth to the show, but only 2 days’ worth arrived, so someone was having a tremendous barbecue on Nebraska’s dime). My only imperative was to get out of the show early enough to catch the 3:15 Acela. I was booked on the 4:30, but the exhibit hall closed at 3:00 and I thought I might be able to make it.

Unfortunately, there was a massive line for cabs, so I walked down Summer St. with my suitcase and briefcase. I got to South Station just as the 3:15 Acela was about to leave. I wasn’t able to get my 4:30 ticket exchanged in time (I’ve seen them kick a passenger off), so I killed 75 minutes in South Station, getting a late lunch and sneaking into the Acela Club to goof around on the internet for a while, before boarding the quiet car for the ride home.

I was hoping to get some reading or writing done, but I was unable to focus on anything (it was probably allergy-related). I surrendered, popped in my headphones, and set my iPod to shuffle for 3+ hours. I haven’t done that in a long time, just listening to music and watching the landscape, but that’s where I was.

Near the outset, the train picked up great speed (around 150 mph, I think), which made a blur of the scenery. When we zoomed past parking lots, and the afternoon sun gleamed off the windshields with sharp contrast, I felt like I was watching Trainspotting, or the beginning of Shallow Grave, pounding through the landscape at high speed. It didn’t feel the same in the open areas and fields, but the combination of our velocity and human surroundings somehow tripped me out.

It didn’t last long. Much of the trip was through those empty fields, and most of the civilized areas required that we slow down. Fortunately, the trip had an entertaining conclusion.

See, the Acela stops in Penn Station in NYC for about 10 minutes, before heading out for the second half of its trip. It’s the stop where the most passenger-flux occurs, what with NYC being the center of the world and all.

Anyway, one of the passengers who boarded the quiet car at that stop bore a strong resemblance to Christopher Hitchens. I wasn’t sure it was him, until he walked down the aisle a minute or so later and passed by my seat. I thought, “He’s probably looking for a seat in a less crowded car,” and went back to listening to my music.

A minute later, I thought, “You moron! He’s heading down to the cafe car to buy as much alcohol as possible to last through the trip down to Washington, DC!”

Five minutes later, I was proved correct. He came walking back up the aisle with a cardboard tray containing a couple of drinks. He was stuck by my seat for a moment, because a passenger was restowing a bag. I said, “Excuse me: Mr. Hitchens?”

“Yes?”

“I just wanted to let you know that my wife and I really enjoy your books and essays.”

“Why, thank you,” he said, trying to balance the tray as he headed back to his seat.

Shortly, he headed back down the aisle to another car, carrying some trash. The train would shortly pull into Newark, so I got my bags and waited by the door. He came back up the aisle and re-greeted me, shaking my hand and thanking me for the kind words.

I said, “Actually, it turns out that we have a mutual friend in Elayne Tobin.”

He perked up. “You know Elayne? You’re from Pittsburgh, then?” It was a good guess, since she got her Ph.D. there.

I said, “New Jersey. A mutual friend introduced us. He met her when they were teaching at Temple: Samuel Delany.”

“I think she introduced us once. Science fiction writer?”

“Yes. With a huge white beard.”

“That would definitely be him.”

We talked for a few moments more, until the train pulled in. I wished him a a safe trip, and he told me to give Elayne a pinch on the cheek from him.

“She’d probably take a swing at me if I did that, but I’ll try.”

He smiled, and headed back to his seat.

So that was Boston/BIO, dear readers. Epically boring, as I warned.

(Go check out the slideshows of BIO pix and Boston pix , if’n yer interested.)

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Bio Logic

I’m off to the BIO conference in Boston, dear readers! Blogging may be pretty light, as I likely won’t have much free time, between exhibit hall hours and dinner. Still, I’ll try to take neat pix, make funny observations, and otherwise entertain you when I’m back.

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Road trip!

Actually, it’s not much of a trip: we have a conference in NYC this week, so I’ll be staying at a little hotel near Times Square for the next couple of nights. Since the exhibit hall doesn’t open till 10am, I should have a little time for blogging in the morning. On the other hand, we’ll also be taking clients out for dinner, etc., so I may be in no shape to write in the morning.

Don’t expect so much outta me, okay?

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Flat Panels, Cratering Sales

Here’s an article from BW about how Wal-Mart’s flat-panel TV pricing for the 2006 holidays helped destroy a number of electronics stores. Looks like the chain’s decision to sell a 42-inch Panasonic for under $1,000 sent its (partial) competitors off a price-war cliff:

Along with Wal-Mart’s determination to lower prices, two other factors played key roles in last winter’s 40%-to-50% flat-panel price drop and the ensuing turmoil. For one, many more retailers such as Sears and CompUSA were starting to stock a wider selection of flat-panel TVs after seeing demand soar over the previous two years. Also, manufacturers like Samsung, Sony, Panasonic, and Westinghouse had ramped up production last year with new factories in Asia and the U.S. They began flooding the market with new TVs in the latter half of 2006. All these forces combined to make a commodity of what just six months earlier had been a solidly high-end, high-margin entertainment product. “It’s Econ 101: Best Buy and Circuit City had seen fat margins from flat-panel TVs for a while, and as it happens with any product, eventually the margins come down and the music stops,” says David Abella, a portfolio manager at New York-based Rochdale Investment Management, with assets of $2 billion.

Wal-Mart is the second-largest electronics retailer today, behind Best Buy, which has fared relatively well compared to many of its rivals. But it has done so by imitating some of Wal-Mart’s best practices, most notably an efficient supply chain, by the admission of CEO Brad Anderson himself. It also has more diversified merchandise than other specialty-electronics retailers.

I think the collapse of CompUSA — and maybe some of the other retailers — was also triggered by the post-holiday delay of Windows Vista and the ensuing realization that Vista wasn’t a compelling reason to buy a new computer, but that’s just my pet theory. I’m sure the demolition of flat-screen margins was the biggest factor, given the amount of floor space all of these chains devoted to those TVs. I’m fascinated by the way different sectors become commoditized.

The pharma biz, which I cover, has historically been insulated against that (until a drug’s patent life expires, that is), leading to less concern about reducing manufacturing costs. That’s changing nowadays, insofar as major companies are trying to wring excess costs out of manufacturing processes, but the market prices (and the high cost of regulatory compliance) still insulate them.

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Pinky and the — oh, never mind

Here at my illustrious day job, I get a lot of invites to pharma-conferences. Some have good presenters whom I can work with to write articles for the mag. Others are hardcore technical science conferences, which are beyond the scope of what we cover.

Now, the 10th Annual International Conference on Drug Metabolism/Applied Pharmacokinetics, is definitely in the latter class but, on a whim, I looked through the event schedule just now to see if there were any presentations that might be adaptable for the mag. What did I find?

11:00am – Brain Transporters – Jashvant (Jash) Unadkat, Ph.D., Professor, School of Pharmacy, Department of Pharmaceutics, University of Washington, Seattle, WA

And it’s followed by a tour of Wollersheim Winery!

Now I’m kicking myself for not being a scientist.

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U.S. Pharmacopeia

A month ago, I mentioned the amazing tox breakdown from Gerald Levert’s autopsy. I felt like Steve Howe really let us down by only having meth in his system when he flipped his truck last year.

Fortunately, the Anna Nicole Smith tox report came out yesterday, and it’s restored my faith in drug-abusing celebrities:

  • Chloral hydrate: A drug typically used in hospitals for pre- and postsurgery patients struggling to sleep or in great pain
  • Diphendydramine: Over-the-counter Benadryl cures itching, sneezing and other allergy-related symptoms.
  • Clonazepam: Prescription Klonopin is used to treat seizures and panic- and anxiety-related disorders.
  • Diazepam: Prescription Valium is used as a sedative for panic- and anxiety-related disorders.
  • Nordiazepam: Metabolized Valium
  • Temazepam: Prescription Restoril is a sleep aide commonly used in hospitals.
  • Oxazepam: Prescription Serax is used as a sedative for panic- and anxiety-related disorders.
  • Lorazepam: Prescription Ativan is used as a sedative for panic- and anxiety-related disorders.

Evidently, some of this stuff was being injested because of a painful abscess in her butt, the result of . . . intramuscular injection of HGH or B12 for “longevity” treatments! Well played!