The View from Pharma-dur

I am so pleased to see that Adam Kay's masterwork has made it to the big time: YouTube. Happy holidays, bonobos! (Pharma-phunnies, some medically graphic, contained therein.)
After coping with an immediate family member's severe illness (thankfully resolved; better living through chemistry pays off) and discovering that my talents do not lie in management within a very large company, I stepped back from my almost 20 year career in discovery research several months ago. I gleefully wallowed around the home front, decompressing from an especially stressful time in my life and just generally vegetating. But I kept my foot in the door of the Dark Tower of Pharma-dur by taking a class in drug development in a regulatory affairs program at a (sort of) local…
Finally! A prescription medication tailor-made for me! From the makers of Damitol and Fukitol, here is...
Judah Folkman, a most extraordinary scientist, died Monday at age 74. Orac (Respectful Insolence) posted a fitting tribute which I highly recommend. See also Alex's (Daily Transcript) entry and this New York Times article. Thanks to the intricate academic vascular network between Harvard and Boston biotech, Folkman visited the company in Cambridge MA for which I previously worked. His seminar enthralled us and exemplified his ability to communicate so effectively. Folkman's persistent championship of the anti-angiogenic drugs born of his research illustrates his belief in his work and…
One of the more recent offerings in the pernicious practice of direct-to-consumer (DTC) advertising from Big Pharma is a tortoise and a hare hawking a smoking cessation med: Chantix. The drug, varenicline tartrate, has a dual action in that it acts as both a partial agonist (enhancing activity but not by too much) and antagonist (blocker) of the alpha2beta4 nicotinic acid acetylcholine receptors. These are ligand-gated ion channel receptors, a major class of receptors in the CNS which comprises the targets for many drugs. Here's an illustration of a nicotinic acetylcholine receptor,…
One of my to-do tasks includes making some revisions to a standard operating procedure draft document for lab notebook policies for our division. I'm a member of an "executive lab notebook committee" or as I fondly like to call my assignment, the stinking albatross that hangs around my neck. The confluence of discovery scientists and attorneys is an uneasy one, and acting as an intermediary between the two factions can get pretty stinky in that dead-avian pendant way. I have no one to blame but myself for landing in this role. I made the grievous error of telling my boss about my prior…
When I find myself in times of trouble Ben and Jerry's comes to me Snarfing Chunky Monkey so sweetly, so sweetly. When stressed, some folks barely eat and consequently lose weight. Others, including myself, reach for high-fat-high-sugar (HFS) foods in an attempt to ameliorate the angst. Although the connection between stress and overeating is not fully understood, the evidence until recently focused on centrally acting (brain & spinal cord) mechanisms, e.g., hypothalamic control of food consumption and metabolism. However, Lydia Kuo et al. (1) reported recently in Nature Medicine that…
The Teh finally hit the conservative pages of Scrip World Pharmaceutical News. Wyeth's new antipsychotic receives FDA non-approvable letter after fatality August 13, 2007 Scrip The US FDA has issued a non-approvable letter for Wyeth/Solvay's new-generation atypical antipsychotic bifeprunox, which was under review for the acute treatment of schizophrenia and the maintenance of stable adult patients. Wyeth's share price on teh New York Stock Exchange closed at $46.59, down by 6% on August 10th. (emphasis mine) OK, it may just be a typo, but I'd like to think it's an oh-so-hip ironic reference…
Following up on the wacky tobaccy post, the FDA advisory panel voted 14-0 against recommendation of rimonabant to move forward as a treatment for obesity, citing the need for further safety studies. As noted, the primary concerns are psychiatric/neurological issues. I really can't resist a "No shit, Sherlock!" as pertains to the psychiatric and neurological issues. The endocannabinoid system is under scrutiny for psychiatric indications, i.e., new antidepressants and anxiolytics. It's not exactly unexpected that such adverse effects might arise given the different responses among…
Today, the FDA's Endocrinologic and Metabologic Advisory Committee reviews rimonabant, the cannabinoid receptor antagonist developed by Sanofi-Aventis, for recommendations, or lack thereof, as an anti-obesity medication. Rimonabant was approved in Europe for limited cohorts of obese patients, but rejected as an anti-smoking medication. Approval for marketing rimonabant in the US is pending next month, and the advisory committee's assessment will weigh heavily on this decision. There are other 'bants in the pharma pipeline so it should be interesting to see how today's decision plays out…
Three pant-hoots and a grooming session to my very favorite cheeky pharma-insider monkey over at PharmaGossip (see the Chimp Refuge Blogroll) for the following, Can Peter Rost be silenced? including the link therein which led me to... ...the reprint of the article on Peter Rost in Fortune Magazine, posted on Dr. Rost's blog: Fortune: "Peter Rost has become the drug industry's most annoying - and effective - online scourge. As a pharma discovery scientist, I regard marketing as the Devil Incarnate in its current form, and it's refreshing to see someone pitbulling them. But will Rost can hold…
Orac clearly knows too much. For an accurate look at a Big Pharma board room, check out The pharma conspiracy acts against a threat. Orac, with his delightful and respectful insolence, reveals why Dan Olmsted, Thimerosal-Conspiracy- Crusader Extraordinaire, is actually Pharma's Best Friend. Orac's characterization of MegaPharmCo's head honcho, ESB, is pretty accurate, too, e.g., + = .Most Big Pharma CEOs
As much as it pains me (1) to honor the request (2) by Dave of The World's Fair, I'll play: 1. Can you show us your coffee cup? Here's my work-a-day mug at my desk flanked by its friends (see answer to item 3). This photo, taken with the marginal little camera in my PDA, is in violation of DOPI (3) policy since I am revealing the kind of printer we use, proprietary information which I am sure will set back our competition by 20 years. 2. Can you comment on it? Do you think it reflects on your personality? The text on the mug says "She Who Must Be Obeyed." It was purchased for me from the…
Long time no see. I took something of a hiatus from the hootacular environs of the Refuge due to the Most Wonderful Time of the Year at DOPI:* performance reviews for 2006 and objectives setting for 2007. I know. I shouldn't whine and bitch about this, seeing how much work you academics put into the grant writing process in the unending effort to suck at the NIH/NCI/NSF/IYAH** teat, and I can appreciate how difficult that is. After seeing my grad advisor lose a significant grant (since regained) during the heyday of Ronnie Reagan years when 0.0000037% of all NIH grants were funded, I…
Let's see, the Biz shot its right foot with the Vioxx debacle, then its left foot with Zyprexa (and others, but that's a recent one), so now it must look for another site for further damage of its tattered n' shattered image. Hmmm, how about lobbing off a couple of fingers? The FDA's approval of Slentrol, Pfizer's new chemical entity (NCE) for treatment of obese dogs ought to do the trick. Zing! There go the fingers. As a minion of the dark overlords, I have to say that the announcement made me cringe for a number of reasons, the primary one being that this further solidifies the…
With the latest Big Pharma debacle ("Hey, let's shoot ourselves in the other foot") from the Prozacasaurus' overmarketing of Zyprexa (see Grrl's, Jake's, and David's (addendum, 12/21) blog entries on the subject), this recent (and free access) article from PLoS Medicine: Educating Health Professionals about Drug and Device Promotion: Advocates' Recommendations seems particularly relevant. Nephrology News and Issues provided a good summary of the PLoS article: A group of physicians and advocacy groups is taking on pharmaceutical promotions, calling in a journal article for an overhaul of…
Over at Terra Sigillata, Abel Pharmboy dissects the deeper meaning of the Rozarem ad which features Abe Lincoln, a beaver and a scuba diver telling an insomniac how much they miss him. The ad is hawking Takeda Pharm's latest little sleeping pill. The Rozarem campaign is a departure from the usual direct-to-consumer drug advertising. It's certainly edgier and more surreal than Mandy Patinkin looking sincerely into the camera and urging you to "ask your doctor about Crestor." I am not a fan (to say the least) of pharma's DTC advertising, but I'll leave my frothing rant on that subject for…
A pant-hoot of appreciation goes out to United Kingdom bonobo, grimupnorth, for passing this along. Adam Kay is a junior doctor from the UK who passes his limited spare time by writing songs, including one about a new wonder-drug called Paracetamoxyfrusebendroneomycin. He's built up a cult following, and he's currently selling out at the Edinburgh festival. There are some clips from the songs on this site: The Friday Project ("Paracetamoxyfrusebendroneomycin" contained therein - Doc Bushwell) He gives all proceeds from his album sales to a cancer charity. See what you think. Adam Kay has a…
After being buggery-augered with no lube by the New England Journal of Medicine's finest, it's refreshing for us minions of Big Bad Pharma and our small company lampreys to read an article in that august journal which moves beyond Angellic knee jerk histrionics. Alastair J.J. Wood, M.D. offers a proposal for radical changes in the drug-approval process. As Joseph j7uy5, proprietor of Corpus Callosum notes, this is a free access article and a worthwhile read. Wood's proposals include severe kicking of the tires for me-too drugs, follow-up on safety after a drug's launch, demonstration of…
When Gleevec hit the market in 2001 for chronic myelogenous leukemia , it was hailed as a major breakthrough in cancer treatment. Gleevec, which inhibits bcr-abl kinase, was the harbinger of targeted chemotherapy and represented a departure from the cytotoxics which, although effective, possess a broad array of adverse effects. A History of STI 571, written by Brian Druker, M.D., the principal investigator who championed the compound, not only illustrates the genesis of the drug itself but also the interdisciplinary teamwork required for drug discovery. Behind Gleevec came Iressa, Astra…