Archive → November, 2010
The Colorado Daily reported this evening on a chemical explosion that injured an unidentified PhD student at the University of Colorado Engineering Center in Boulder. Few details are available now but don’t let the photos of the firefighters put you off – the accident could have been far worse.
Emergency crews evacuated the University of Colorado Engineering Center this afternoon after chemicals exploded in a beaker and the exploding glass shards cut a 28-year-old doctoral student’s forehead.
The student was mixing chemicals in a room in the Engineering Center’s “chemical engineering” wing. No one else was injured, according to Bronson Hilliard, spokesman for CU-Boulder.
The student — whose name is not being released — walked himself to Wardenburg Health Center on campus.
Glass shards in the forehead tell me that the student was likely wearing appropriate eye protection. My guess is that we could have been reading about a student who was tragically blinded.
We send our best wishes to the student and to our colleagues at the CU Department of Chemical and Biological Engineering.
A slightly different version of this post appeared yesterday at my Take As Directed blog.
Just before we in the US took off for the holiday, the US Drug Enforcement Agency released notice of “emergency scheduling” of synthetic cannabimimetic compounds currently sold in herbal incense products. Products like K2, Spice, Black Mamba, and pure compounds such as JWH-018 have been a boon for convenience stores, head shops, and internet retailers (not to mention huge, sustained traffic benefits for bloggers.). The complete text of the rule can be found here at the DEA website.
Already outlawed in Europe and with various bans in 15 states, these products are now officially viewed by DEA as worthy of “schedul[ing] an abused, harmful, non-medical substance in order to avoid an imminent public health crisis while the formal rule-making procedures described in the CSA are being conducted.”
What this means is that the DEA is going to release within 30 days a notice of formal ban of five chemicals – JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol – via temporary assignment to Schedule I, the US classification for drugs with no known medical benefit but that possess high abuse potential or are otherwise unduly harmful. This classification will then make these compounds temporarily illegal to sell or possess for one year (with a possibly six-month extension) while the DEA conducts studies and procedures for formal assignment to Schedule I.
Ted’s tweet referred me to an open letter that Dr. Petsko wrote in Genome Biology to the President of SUNY-Albany, George M. Philip. Now referred to as UAlbany, that state university campus announced six weeks ago that they were suspending admissions and eliminating several arts and humanities departments, including French, Italian, Classics, and the Theatre Arts.
President Philip himself earned a BA and MA in history from UAlbany and a JD from Western New England College School of Law. He became president of the university in 2009 after having been chief investment officer of the New York State Teachers Retirement System, described in his university bio as “one of the 10 largest public retirement funds in the nation, with more than 400,000 members and managed assets of $105 billion.”
Petsko, US National Academy of Sciences member and past-president of the American Society of Biochemistry and Molecular Biology, crafted a simply beautiful defense of the value of broad university education. I’ll just direct you to read it because he is such a clear communicator with a quietly biting wit. In case you don’t have time right now, here’s one paragraph to give you the gestalt – Petsko uses as an example his own monthly column in Genome Biology:
Organometallics chemist and NSF CAREER awardee, Dr. Quinetta D. Shelby, has been denied tenure in the Department of Chemistry at DePaul University even after an institutional appeals committee determined that her negative departmental review was flawed. According to a note at Inside Higher Ed on Thursday:
Supporters of Quinetta Shelby released documents Wednesday suggesting bias in her tenure denial at DePaul University. Shelby is the only black faculty member in the chemistry department at the university, and while she was rejected by her department, a university appeals panel found that she was treated unfairly. Among other things, the appeals panel found that her department changed policies after the review started, refused to consider some of her publications and awards even though they met criteria that had been established, and seemed to focus on minor negative issues in otherwise positive portions of her tenure file. The “numerous procedural violations” raised significant questions of fairness, the appeals panel found, suggesting that the negative departmental recommendation be set aside.
The Rev. Dennis Holtschneider, DePaul’s president, has declined to reverse the decision.
After writing this week about the new, direct-acting antithrombotic drugs that threaten to replace the stalwart anticoagulant, warfarin, comes news that the joint BMS/Pfizer development of apixaban has hit a snag. From Jonathan Rockoff and Kathy Shwiff in the Wall Street Journal:
Pfizer Inc. and Bristol-Myers Squibb Co. said they’ve halted one the key trials for an experimental blood-thinning drug that is one of their brightest pipeline prospects, though other pivotal studies remain on course.
The phase III study of apixaban was examining whether the pill reduces the incidence of strokes or heart attacks caused by coronary heart disease, but early results indicated it didn’t while raising the risk of bleeding. The companies said they had acted at the recommendation of an independent data-monitoring committee. All patients will be taken off the drug and the results evaluated and made public, the companies added.
Eight other trials of apixaban are ongoing in other patient populations.
Mechanistically, apixaban is most similar to rivaroxaban (Xarelto, Bayer/J&J) a direct Factor Xa inhibitor discussed this week at the American Heart Association meeting. Rivaroxaban exhibited efficacy similar to warfarin in reducing clots of atrial fibrillation patients but had caused fewer spontaneous bleeding episodes.
A careful examination of the opposite effect of apixaban in patients with coronary heart disease will be essential to understanding whether this is a function of the drug (relative to rivaroxaban) or peculiar to the patient populations studied.
Well, that was fast. After a year-long investigation of pre-made, highly-caffeinated alcoholic beverages, the US FDA today warned four companies to go decaf.
The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.
The companies receiving Warning Letters and their products are:
• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max
FDA’s action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”
Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.
That last paragraph was what I focused upon in my post over the weekend that was stimulated by a frontpage Raleigh News & Observer article by higher ed reporter, Eric Ferreri (@campus_notes). Large amounts of caffeine taken with a 23.5 ounce beverage containing 12% (v/v) ethanol deceives the drinker into thinking they are less drunk than their motor skills or blood alcohol concentration would reveal. I’m not one for a nanny state but this is in a nutshell is the threat to public health with highly-caffeinated alcoholic beverages.
A couple of my dear Twitter followers were having sport with me today about these products and some asked why FDA is acting on these products but not the practice of mixing vodka and Red Bull or whiskey with coffee. The major reason is that these are prepared food products (I’d also add that Four Loko has four times the caffeine as a typical Red Bull).
From the FDA’s Q&A today:
Under what authority is FDA issuing these Warning Letters?
FDA is issuing the four Warning Letters under its authority to implement the Federal Food, Drug, and Cosmetic Act (the FFDCA). Under the FFDCA, a substance added to food (such as caffeine added to an alcoholic beverage) is deemed an “unsafe food additive” and is unlawful unless its particular use has been approved by FDA, is the subject of a prior sanction, or is generally recognized as safe (GRAS). A food that contains an unsafe food additive is deemed adulterated under Section 402(a)(2) of the FFDCA [21 U.S.C. 342(a)(2)]; adulterated foods are subject to agency enforcement actions, including seizure.
The FDA has only listed caffeine as GRAS as an ingredient for use in cola-type beverages in concentrations of no greater than 200 parts per million. There is no food additive regulation that permits the addition of caffeine, at any level, to an alcoholic beverage. Based on the information FDA has reviewed, the agency does not consider the use of caffeine in the products listed above to be GRAS.
What puzzles me is that most of the public and media concern has been with regard to the caffeine with little discussion of the alcohol content. As I noted over the weekend, one can of Four Loko is approximately the same volume and alcohol content as an entire bottle of wine (or 4+ decent beers.). In fact, the folks at BuzzFeed got it wrong yesterday when they offered their own recipe for homebrewed Four Loko: Five watermelon Jolly Rancher candies, a caffeine pill, a can of Sprite, a can of Monster Energy Drink, and a 40 oz bottle of St. Ides malt liquor. St. Ides is 8.3% ABV and when diluted out with the soda and energy drink, you’ve got about 68 oz of 4.9% ABV swill.
BuzzFeed friends and readers: You’d still have to drink 58 oz of this loathsome assault on humanity to equal the amount of alcohol in a single 23.5 oz can of Four Loko. This fact alone should make apparent to even defenders of Red Bull and vodka that this stuff is, uh, roughly four crazy drinks.
Four. Crazy. Drinks.
I finally get it.
So now, assuming the companies respond to their FDA warning letters, we’ll simply have products in the cooler that are insipid, fruit-flavored beverages with 12% alcohol.
Now that I don’t have to be graded on my memorization of the blood clotting cascade, let me just step back for a second and express awe for the physiological process of hemostasis. Think about this: we have to maintain our blood in a freely circulating form 99.999% of the time but as soon as there is a breach in the system, we have to quickly mobilize a cascade of events to prevent catastrophic blood loss. Pharmacological fiddling with this exquisitely controlled process is bound to have complications. But we have learn to walk this tightrope with drugs to prevent blood clots following stroke, orthopedic surgery, vascular stent implant, and other procedures and disorders that might cause such emboli to travel to our lungs, heart, or brain.
News yesterday from the American Heart Association meeting in Chicago brought our attention to a new class of anticoagulant drugs that may finally knock the coumarin, warfarin (Coumadin, racemic mixture), off its lofty pedestal as the oral antithrombotic drug of the last six-plus decades. Yes, the standard of care for about 65 years. The large, ROCKET AF trial presented yesterday had investigated the efficacy and side effect profile of warfarin relative to rivaroxaban (Xarelto, Bayer/J&J), a once-daily, oral inhibitor of the clotting factor, Factor Xa (part of a complex that converts prothrombin to the endogenous coagulation protein, thrombin).
Our dear colleague, Dr. Derek Lowe, had a post yesterday presenting a letter from a reader addressed to C&EN that they felt wouldn’t be published because the author wishes to remain anonymous.
While I lack the reach of Derek’s In The Pipeline, this humble blog is at least on the pixel side of the mag. Of course, everyone here already has In The Pipeline in their blogroll, but I thought I’d offer further support to Derek’s reader in their response to a C&EN article on outsourcing to provide some realism that might not be appreciated by industry beancounters:
Royce Murray, the University of North Carolina at Chapel Hill chemistry professor recently recognized at the ACS National Meeting for his five decades of work, received another lofty award this weekend: The Raleigh News & Observer “Tar Heel of the Week.”
For folks outside the Research Triangle area, “Tar Heel” in this case does not refer just to University fans but rather all inhabitants of the state. The particular newspaper honor is bestowed weekly upon any citizen of the North Carolina who has made a significant impact on our diverse communities and raised the stature of our institutions and industries nationally and internationally.
There’s been lots of discussion in the blogosphere and Twittersphere this week about Matthew Herper’s excellent profile of CRO CEO, Dennis Gillings, entitled Money, Math, and Medicine, and a follow-up this morning on Gillings’ comments about China overtaking the US in biotech prominence.
The profile is planned for the November 22nd print issue of Forbes magazine but appeared online earlier this week.
Gillings is a local hero in the Research Triangle area as a former UNC-Chapel Hill professor who has developed a privately-held company that Herper says has “annual sales of $3 billion, $500 million in earnings before interest, taxes, depreciation and amortization, and $400 million in free cash flow.” Gillings and his wife, Joan, also gave a $50 million gift to UNC in 2007 – the largest ever in the 221-year history of the university – and are the namesakes of their highly-regarded Global School of Public Health (disclosure: my wife is a MPH student and preventive medicine resident there).
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