terrasig | April 12, 2007Over the last year or so, the US FDA has grown tougher on withdrawing prescription and over-the-counter drugs that have not met the modern burden of proof for safety and efficacy that was officially required by the 1962 passage of the Kefauver-Harris amendments to the 1906 Federal Food and Drug Act (WaPo overview from June 2006 here). This legislation not only gave us the modern structure of preclinical and clincal trials, but it also required that drugs sold previously between 1938 and 1962 had to meet this standard of proof of safety and effectiveness.
But, it didn't make financial sense…
terrasig | April 11, 2007The weekly NCI Cancer Bulletin recently featured a clinical trial being led by MD Anderson Cancer Center in Houston where the supplement, alpha-lipoic acid, is being investigated to minimize the peripheral neuropathy associated with platinum-based chemotherapy such as cisplatin or oxaliplatin.
Peripheral neuropathy is an unpleasant side effect of platinum-based chemotherapy that is characterized by a burning, numbness, and or tingling in the extremities. The acute form of the syndrome resolves a few days after the platinum treatment but sometimes persists. A similar syndrome occurs in…
terrasig | April 11, 2007
As alerted by other ScienceBloggers, I have recently learned that the US Fish & Wildlife Service is proposing to the White House that Florida's manatee be removed from the "endangered" list, downgrading the marine mammal to merely "threatened." The result would be a relaxation of boating speed and access rules that have allowed the manatee population to recover over the last 15 years.
Like Shelley of Retrospectacle and Kevin Beck of Dr. Joan Bushwell's Chimpanzee Refuge, I spent a few years of my prime years in Florida (evidence of my support of manatee preservation above). I continue…
terrasig | April 8, 2007The relatively recent addition to ScienceBlogs, first-year medical resident, Signout, very generously tagged me with recognition as a "Thinking Blogger" on her list of "Five Blogs that Make Me Think." This meme was started in early February by Ilker Yoldas for peers to recognize content-rich blogs. Signout was all too kind:
A neighbor here at SB, Abel Pharmboy is a pharmacologist who writes critically and eloquently about all manner of issues in drug research and development. He's consistently both interesting and educational, and handles even conceptually dense issues with a light touch.
I…
terrasig | April 7, 2007From a news release by the University of California at Davis:
The new study, published in this month's issue of Environmental Health Perspectives - available online at www.ehponline.org - was prompted by the case of a 54-year-old woman who was seen at the UCD Occupational Medicine Clinic following a two-year history of worsening hair loss, fatigue and memory loss.
Seafood is our primary source of arsenic in the food supply and we all have detectable arsenic in our blood after a plate of oysters. But this case was particularly disturbing:
Over a period of several months, the woman's short-…
terrasig | April 6, 2007...my attention was raised to another mitochondrial glycolysis inhibitor being touted for anticancer utility. From a 1 April New York Times Op-Ed by Ralph W. Moss entitled, "Patents Over Patients":
In 2004, Johns Hopkins researchers discovered that an off-the-shelf compound called 3-bromopyruvate could arrest the growth of liver cancer in rats. The results were dramatic; moreover, the investigators estimated that the cost to treat patients would be around 70 cents per day. Yet, three years later, no major drug company has shown interest in developing this drug for human use.
I don't know…
terrasig | April 4, 2007I noted a couple of days ago the voluntary withdrawal of a drug used to treat Parkinson's disease called pergolide (Permax). The reason for the withdrawal is that the drug has been linked to reports of valvular heart disease (VHD) and I promised further explanation. The story is a continuing episode in pharmacology and drug safety that has been developing since 2000 or so when the diet drug combination, Fen-Phen, was withdrawn for a similar reason.
But what do diet drugs have to do with a drug for Parkinson's disease?
These stories illustrate just how much we have to learn about the human…
terrasig | April 2, 2007A bad day for pharma on the newswires:
Pfizer subsidiaries agree to pay $34.7 million in fines
Two subsidiaries of Pfizer Inc. have agreed to pay fines totaling $34.7 million for offering a kickback to recommend company drugs and for illegally promoting the human growth hormone product Genotropin for non-approved uses, federal prosecutors announced Monday. Prosecutors allege that Pharmacia & Upjohn Co. Inc. offered to overpay a subsidiary of a pharmacy benefit manager by $12.3 million in the hope the company would, in turn, recommend Pharmacia's drug products to its clients.
Pharmacy…
terrasig | April 1, 2007Doug Farrago, MD, is a private practice doc in Maine who has been publishing the print medical satire journal, Placebo Journal, since 2001. Doug does it all, including spoofing drug company adverts, collecting humorous doc stories, and generally poking fun at drug reps, HMOs, and lawyers.
About two years ago, Doug started sending out e-mails of the Placebo Gazette, a rather bloggy and somewhat more serious newsletter of issues facing docs and medicine in general. Imagine my surprise in Placebo Gazette #81 where Dr Farrago threatened to start writing a blog:
The Detroit Free Press did an…
terrasig | March 31, 2007Leave it to the British to suggest bringing civility to blogging, specifically in blog comment threads, with a call for a suggested code of conduct. This follows blogger Kathy Sierra receiving vulgar and graphic death threats on her and others' blogs. (Kathy writes the techie blog, Creating Passionate Users.). As a result, Sierra canceled her appearances this week at a San Diego tech conference.
Citing a post from Tim O'Reilly of O'Reilly Media, Inc. about this disturbing episode, Jack Schofield of the UK Guardian's Technology Blog notes that The Guardian has adopted a new comments policy…
terrasig | March 30, 2007No real wine column this week, although you may care (or not) that I am enjoying a glass of 2003 Thorpe McLaren Vale Shiraz Reserve while writing. Australian winemaker Linda Domas is highly favored at my local wine wholesaler and this intense but nicely balanced Shiraz is made even more lucscious by the fact I paid about $20 for a wine that now retails at $35-45.
But I digress.
I've wanted to share with readers my love for The Week, digest of the best of US and international media that has been published for about five years. If I can't get around to reading my local paper, The Week does a…
terrasig | March 30, 2007You may have read that pergolide (Permax), a drug used to treat Parkinson's disease, has been withdrawn voluntarily from the US market due to its causal association with heart valve abnormalities. I hope to have time later to discuss why these heart problems occur and why other Parkinson's drugs that act by a similar mechanism of action are still safe.
But for Parkinson's patients, there is a very, very important point made in the FDA's press release:
Pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine agonist therapies can be dangerous. Instead,…
terrasig | March 27, 2007A few years ago, GlaxoSmithKline marketed Remifemin brand of black cohosh extract from their consumer products division as a hormone-free alternative in managing menopausal symptoms. But after reports surfaced that black cohosh might be associated with cases of liver damage, GSK very quietly walked away. (To date, no one has ever shown that black cohosh is causally associated with liver damage). A company called Enzymatic Therapy continues to sell this product in the US, one that is manufactured by Schaper & Bruemmer in Germany.
Well, here's what happens when GSK gets involved in…
terrasig | March 25, 2007I noted just last week the latest review by Drs Newman and Cragg citing that nature remains the source of 70% of prescription drugs. Wall Street Journal medical reporter Ron Winslow took his turn yesterday contributing to the paper's new HealthBlog from New Orleans, site of the American College of Cardiology meeting.
Turns out that a semi-synthetic analog of a compound derived from the bark of Australian magnolia may enhance anti-clotting therapy following stent implants without increasing bleeding risks. The parent molecule and the analog tested in this trial act as antagonists, or…
terrasig | March 24, 2007Docs have a million of these kinds of stories, but pediatrician Dr Clark Bartram at Unintelligent Design put up a particularly moving reflection on a recent case.
terrasig | March 23, 2007For your Saturday morning reading pleasure, here are two articles following up on my dichloroacetate (DCA) and bogus internet pharmacy death posts this week. Each was recommended by my clandestine operative from the Great White North, PharmCanuck:
Canadian cancer society warns of untested drug
Heather Logan, the director of cancer control policy at the society who trained as a nurse, has worked with people fighting to prolong their lives. Logan said she sympathizes with those who are buying the drug and mixing it at home as a last resort, but stresses there are serious safety concerns.
"The…
terrasig | March 23, 2007I must extend hearty apologies to my colleague, wine and research mentor, and guest blogger Erleichda for overlooking a great wine column he wrote for Terra Sig back in November. November! How could I overlook a post whose third paragraph begins, "The evening began with three different champagnes..."?!? As The Friday Fermentable has been running on-and-off, I should be more grateful to him for keeping this Friday fun feature alive. So, here ya go - cheers!
Recent Wine Experiences : A Pinot Noir Revelation
By Erleichda
I grew up with limited exposure to wine, primarily my father's…
terrasig | March 22, 2007By now you've heard about the recent death of Larry (Bud) Melman, the old Late Night With David Letterman character whose real name was Calvert DeForest (NYT obituary).
In an intellectual property dispute, NBC claimed ownership of the Larry (Bud) Melman name, even though it had been devised by a "Letterman" writer, Merrill Markoe. From the moment his face appeared as the center of the CBS eye logo on the debut CBS show, Mr. DeForest used his own name. He parlayed his "Letterman" fame into other film roles and commercials for a wide range of companies including M.C.I., Honda, Cheerios and…
terrasig | March 22, 2007It's been just over a month since we last discussed cases of misfilled internet prescriptions and misbehavior by a US drug wholesaling firm. Yesterday, Sandra Kiume at OmniBrain told us about the death of a woman in British Columbia from what sounds like another case of terribly misrepresented drugs purchased over the internet (a second story is here). As Sandra noted,
A "strong sleeping pill and sedative" which "has been linked to overdose deaths in other countries and is not legally available in Canada" [nobody says which one!] along with an "anti-anxiety" medication and acetaminophen…
terrasig | March 20, 2007So say the American elder statesmen of natural products in the 2007 update of their periodic review of the subject to be published in the 23 March issue of the Journal of Natural Products. (Details are in this Reuters article with by Julie Steenhuysen). I will post more about the article when I get my hands on it, but it comes from NCI's Dr David Newman and recently-retired Dr Gordon Cragg. Cragg had led the NCI Natural Products Branch, a position that Newman now holds.
Newman and colleague Gordon Cragg reviewed the origins of new drugs developed in the past quarter-century and found that…