Pharmaceuticals
terrasig | August 19, 2007Late last week saw two announcements from the US FDA on genetic issues in drug safety. The first of these addresses the prescribing guidelines for Coumadin, or warfarin. Coumadin is a "blood-thinner" (or anticoagulant) prescribed for conditions from heart valve and hip/knee joint replacements to pulmonary hypertension and following strokes due to inappropriate blood clotting.
The reasons for this warning relate to data that has accumulated whereby individual patients respond quite differently to the same dose of Coumadin. Two genetic markers have been identified to account for much of…
terrasig | July 15, 2007Nearly two months ago, we spoke here of the surprising use of arsenic trioxide (Trisenox) in treating various cancers. Trisenox, approved in the US in 2000 for treatment of acute promyelocytic leukemia (APL), is also being investigated for other hematologic malignancies.
Now, the 23 Jul issue of Business Week reports on a company making second-generation arsenicals that are believed to have less toxicity since the arsenic is linked to organic functional groups:
But the arsenic that Ziopharm uses in its Darinaparsin (ZIO-101) is organic, which reduces most toxic side effects, [Ziopharm CEO Dr…
terrasig | May 19, 2007It's nearing the beginning of June, the traditional time for increased stock trading based on results presented at the American Society of Clinical Oncology (ASCO) annual meeting (1-5 June in Chicago). The meeting is often the first time that the general public learns of the progress of cancer drugs in development, often in companies for which many people hold stock. ASCO press releases dominate newspaper business sections during that week because the preliminary release of results influences stock prices.
ASCO released its abstract proceedings book early this week and, the Wall Street…
terrasig | May 2, 2007While the blogosphere buzz is the potential anti-obesity therapy put forth by Ron Evans' group to turn on PPAR-delta, I was reminded of shortcomings in our nation's drug distribution system from the FDA Medwatch program. (I've written about this topic before here and here.).
The latest alert regards a mix-up of weight loss drugs:
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet.
FDA received information showing that 24 apparently…
terrasig | April 23, 2007More Canadian press leads me to put up another post on dichloroacetate (DCA), the inhibitor of mitochondrial aerobic glycolysis that is being promoted as a freely-available cancer "cure." Like many compounds tested in animal models of human cancer, DCA treatment reduces the size of human lung tumors grown in rats, but is far from a cure. Any other similar drug would be just one of hundreds jockeying for investment by drug companies large and small and might not even be competitive enough for entry into clinical trials. However, DCA is a bulk chemical that is largely available freely and is…
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 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 | 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 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 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 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…
terrasig | March 16, 2007I hope Orac won't mind but with him in a surgical conference in DC right now, he may not have seen Matt the Heathen post in the comment thread at Respectful Insolence about a superb article that appeared in today's Edmonton Journal, "Possibly fatal at $2 a pop," by Jodie Sinnema.
Jodie's interview with the University of Alberta investigator and author of the original DCA anticancer paper illustrates the level of interest in this public-domain chemical:
Dr. Evangelos Michelakis, the cardiologist and researcher whose academic paper sparked the worldwide fervour surrounding DCA, said people…
terrasig | February 9, 2007My apologies to those regular readers who may have noticed my recent case of blogger's malaise. A combination of family sicknesses and having to write a fair bit for the day job seems to have interfered with this week's blogging.
So, what to do? Link to other worthy blogs!
This gives me an opportunity to introduce our fairly-recent addition to the ScienceBlogs corral, Karen Ventii and ScienceToLife. Karen is a late-stage biochemistry Ph.D. student down the road apiece at Emory University and posted earlier this morning on the FDA decision to reclassify the prescription diet pill, Xenical (…
terrasig | February 3, 2007I've stood at the periphery of the dichloroacetate (DCA) story mostly because my attention has been needed elsewhere as of late. However, I was very interested in the blogosphere attention given to the Cancer Cell paper from a group led by Dr Evangelos Michelakis at the University of Alberta in Edmonton. The University of Alberta has now set up a website with links to all press coverage on this report as well as a donation page for those who want to support further clinical studies of DCA for cancer.
Long story made short, DCA is a mitochondrial respiratory modulator that reduces lactic…
terrasig | January 31, 2007Pharmaceutical chemist, Derek Lowe, at Corante's In the Pipeline notes that yesterday was the end of his employment at the Wonder Drug Factory due to a site closure. I've admired Dr Lowe since I began reading blogs because he puts a human face on the travails of a bench-level pharmaceutical industry researcher. His thoughtful discussions of chemistry, the industry, and careers for young scientists has put Derek at the top of my reading list most mornings.
Despite the missteps often attributed to pharma execs or marketers, Derek shows that the average pharma scientist is just like the rest…
terrasig | January 17, 2007While I wait for my copy of Dan Hurley's book, "Natural Causes: Death, Lies and Politics in America's Vitamin and Herbal Supplement Industry," it is interesting to read the media reports on his interviews and the responses from the dietary supplement industry.
While the Natural Products Association has simply responded with a measured, educational piece that does not mention Hurley by name, the Council for Responsible Nutrition was all over the wires today dismissing the book as, "not credible."
Some of the most thoughtful discussion today came from CBS News's Public Eye site and a post by…
terrasig | December 8, 2006As Dave Barry would say, I am not making this up.
In yesterday's Wall Street Journal (sub req'd, but I'll quote extensively), Stacy Meichtry wrote on an Italian Roman Catholic religious order whose cancer research laboratory, owned formerly by Pfizer, has recently entered partnerships with this and other major international pharmaceutical companies.
But two years ago, Father Decaminada, a priest and chief financial officer of the Roman Catholic religious order Congregation of the Children of the Immaculate Conception, engineered the acquisition from Pfizer Inc. of a leading Italian…
terrasig | November 30, 2006One of PharmMom's first jobs, before or around the time I was born, was as secretary for a Pfizer drug sales rep back in the golden days of the pharmaceutical industry (1960s). Doc Bushwell and I have been going back and forth the last couple of days on my post regarding Takeda Pharma's interesting (and outsourced) ad campaign for their sleeping pill, Rozerem. (btw, Doc, I look forward to your promised "frothing rant" on direct-to-consumer (DTC) drug advertising.).
Researchers abhor the amount of money poured into pharmaceutical sales and marketing because, as Doc Bushwell and others…