Pharmaceuticals
terrasig | April 23, 2008Just a little blurb in my local paper this morning that is making a big splash in the stock market: international pharma giant GSK is purchasing Cambridge, MA-based Sirtris Pharmaceuticals Inc. for an estimated US$720 million.
Glaxo plans to bolster its pipeline with Sirtris's experimental biotechnology treatments targeting aging-related diseases.
In early trading, Sirtris shares gained 81.6 percent to $22.21 while Glaxo shares added 19 cents to $43.92.
Apparently I should've gone immediately from my morning bathroom newspaper reading to my online stock purchase website. Instead, you get a…
terrasig | March 27, 2008Only time for a short post today but many news outlets are just now picking up on a 12 March WaPo article by David Segal on the 10th anniversary of the US FDA approval of the erectile dysfunction drug, Viagra. As we noted in yesterday's post, the active ingredient in Viagra, sildenafil, is so popular that even dietary supplement manufacturers are doping their products (illegally) with it and other related compounds.
While some may be cracking silly jokes today, Segal's article focuses primarily on the complexities of the female side of sexual relationships and the challenges in psychology…
terrasig | March 20, 2008The safety and effectiveness of medicines and other health products is dependent upon their proper use, particularly the proper route of administration. There are reasons why products are labeled as "for topical use only" or "do not swallow" - two recent warnings from the US FDA illustrate these issues.
Allergic Reactions with Use/Misuse of Denture Cleansers
The FDA recently announced reports of one death and 72 other adverse reactions in individuals who ingested denture cleansers meant to be used in a container with one's dentures removed. A crucial oxidizing agent, salts of persulfate,…
terrasig | March 18, 2008This issue was brought up by my fellow blogger, Joseph at Corpus Callosum, following an article in yesterday's LA Times.
For those not familiar with the concept or countries other than the US where laws may differ, generic drugs are those with the same active chemical as the originally-approved "brand name" drug. The original drug manufacturer is the one that conducts all of the preclinical and clinical safety and efficacy testing, natural product isolation and/or chemical synthesis, formulation with inactive ingredients to assure dissolution and reproducible release of the drug, etc. In…
terrasig | December 10, 2007Yes! "A Call for a Presidential Debate on Science & Technology."
Imagine a presidential debate focused solely on issues of science and technology as they relate to medicine, international competitiveness, terrorism, public health, embryonic stem cell research, bioethics of genotyping and other molecular diagnostics, research policy/funding and job creation, or minimization of health disparities, among others.Science Debate 2008 is a grassroots initiative spearheaded by a growing number of scientists and other concerned citizens. The signatories to our "Call for a Presidential Debate on…
terrasig | December 3, 2007I was way behind on this story relative to the pharma blogosphere (John Mack's Pharma Marketing Blog, Ed Silverman's Pharmalot, and the WSJ Health Blog), but Montel Williams has created a PR disaster for Partnership for Prescription Assistance of the industry group, PhRMA (Pharmaceutical Research and Manufacturers of America).
While promoting prescription assistance programs in Savannah on Friday, Williams blew up, as it were, at a Savannah Morning News high school intern. The intern, Courtney Scott, asked Williams, "Do you think pharmaceutical companies would be discouraged from research…
terrasig | November 17, 2007Readers who are busting their butts doing basic and drug development research in pharmaceutical companies don't need this kind of alleged behavior from upper management - from Jeanne Whalen at the Wall Street Journal (online yesterday and in today's print edition) following up on a story first reported in the Journal on 24 May 2007:
Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance…
terrasig | November 14, 2007...is the title of a Newsweek article by Jonathan Alter posted online last night that draws more attention to the Medicare restriction on reimbursements for radioimmunotherapeutic (RIT) drugs used to treat lymphomas. Surgical oncologist, Orac, and I have spoken about this issue in the last few days.
Alter admits his bias a bit, as he was diagnosed with mantle cell lymphoma back in 2004 and received RIT. Moreover, Alter's Newsweek colleague (and SoCal singer-songwriter), Jaime Reno, attributes RIT to his long-term remission.
The article opens as follows:
What if they found a cure for a…
grrlscientist | November 5, 2007tags: drugs, pharmaceuticals, Drugs and Pharmacology carnival, blog carnival
Hey you guys, the very first edition of the new blog carnival, Drugs and Pharmacology carnival, is now available for you to read. This is a monthly blog carnival that focuses on essays related to drugs -- ranging from the medicinal to the recreational.
terrasig | October 24, 2007We wrote a few days ago on the disappointing discontinuation of Pfizer's Exubera, the first inhaled insulin product.
The always-insightful Dr Derek Lowe at In the Pipeline has an excellent commentary on this case, including his own take on the futility of putting lipstick on a pig:
1. Marketing isn't everything. The next time someone tells you about how drug companies can sell junk that people don't need through their powerful, money-laden sales force, spare a thought for Pfizer. The biggest drug company in the world, with the biggest sales force and the biggest cash reserves, couldn't move…
terrasig | October 18, 2007Scott Hensley at the WSJ.com Health Blog had a banner day today with the sad withdrawal by Pfizer of their inhaled insulin product, Exubera. When I was a pharmacy professor in the mid-1990s, we shared Pharma's optimism that an inhaled insulin product would be a godsend for diabetes patients who had to inject themselves with this essential hormone. The Terra Sig blog also has a historical soft spot for insulin since it was first crystallized by our nom-sake, Prof John Jacob Abel (PNAS 1926; 12:132-6 - PDF here).
Well, Abel must be quite disappointed somewhere out there in the Great Beyond:…
terrasig | October 16, 2007As we discussed here yesterday, ixabepilone, a semi-synthetic anticancer drug derived from a soil bacterium was up for review by the US Food and Drug Administration (FDA). Just over a half hour ago the manufacturer, Bristol-Myers Squibb, announced that the drug has indeed been approved for the treatment of advanced breast cancer. The drug will be sold under the trade name, Ixempra.
"Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options," said Linda Vahdat, M.D., Associate…
terrasig | October 15, 2007Perhaps not a cure but certainly another critical tool in the anticancer armamentarium.
If you've ever read our introduction to the left in my profile as to why this blog is called Terra Sigillata, you'd know that the first trademarked drug was dirt itself (or soil to be exact). Terra Sigillata was a special fatty clay harvested from the Greek isle of Lemnos and then punched into planchets with a special seal. Because it contained kaolin, a component of Kaopectate, it was useful for treating gastrointestinal disorders, and its high mineral content was useful for treating deficiencies that…
terrasig | September 22, 2007The Pump Handle's Liz Borowski put up a nice post summarizing the key points of the >400-page Food and Drug Administration Amendments Act of 2007 (H.R. 3580).
Missing from the bill were any further restrictions on pharmaceutical direct-to-consumer (DTC) drug advertising - according to Liz, some drug safety advocates were calling for a complete ban on DTC ads.
Since the FDA began permitting DTC advertising in 1997, the purpose of the ads has been viewed as less about patient education for underdiagnosed diseases (the original pitch) and more about getting patients to request specific…
terrasig | September 20, 2007You read correctly. If the US Senate does not pass an FDA funding bill today, 2,000 employees, nearly one-quarter of the FDA staff, will be relieved of their duties. (There were 8,157 FDA employees in 2006 - source). The House has already passed the bill but there are concerns:
Senate staffers were poring over the bill's 400-page text, and leaders were hoping to be able to pass it by voice vote. But some Senate Republicans raised concerns. "We're getting a bill that has been mashed together at the last minute," said a GOP aide involved in negotiations with the House. "It's very worrisome…
terrasig | September 16, 2007Leukemia Drug Adulteration
Chinese generic versions of the anticancer drugs, methotrexate and cytarabine hydrochloride, have been reported to be contaminated with an undisclosed substance according to several wire reports this morning.
Several children in a Shanghai hospital were reported to suffer leg pain and difficulty walking after being injected with methotrexate. A common drug used in many chemotherapy regimens for leukemia, methotrexate is not normally associated with these side effects.
The Xinhua news agency reported that the drugs had been traced to one manufacturer, Shanghai…
terrasig | September 15, 2007[This post appeared originally at my Blogspot site on 20 December 2005 to describe my rationale for the name of this blog. With today's traffic from the Daily Kos, I thought it would be useful to new readers to know our story here. FYFI, here is why I chose the pseudonym Abel Pharmboy. - APB]
If you Google, "Terra Sigillata," you'll get a number of hits for various clay pottery recipes. Very complicated stuff, requiring the use of a deflocculant to separate out large clay particles from the small ones. Terra sig, as it is known among pottery hipsters, is then used to coat finished pieces…
terrasig | September 14, 2007[Welcome Daily Kos readers and many thanks to DarkSyde for the link - btw, if you're wondering what Terra Sigillata is, click here.]
The other day I fired off a quick post on the absurdity of the Centers for Medicare and Medicaid Services (CMS) is proposing to cut reimbursements for two radioimmunotherapy drugs for lymphoma to less than their cost. The two immunotherapy drugs in question are Bexxar (I-131 tositumomab) and Zevalin (Y-90 ibritumomab) - both drugs target the CD20 protein on the surface of normal and malignant B-lymphocytes, killing the cells by the radioactive emissions of…
terrasig | September 9, 2007Yes, you have heard this before: another company selling erectile dysfunction dietary supplements has been nailed by the US FDA for adulteration of their product with prescription drugs used for erectile dysfunction.
From the FDA (full press release here):
Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used…
terrasig | August 29, 2007Nick Anthis at The Scientific Activist had a great post yesterday on the fallacies in an article from the UK Guardian detailing a peer-reviewed publication on replacing animal research with in vitro and computational models. As much as all scientists would wish this were true, there are simply no replacements for animal research in many areas, as noted by PZ Myers.
One of my favorite sources for promoting the factual necessity for animal research (and exposing extremist groups for attacks on scientists) is the Washington, DC-based, Foundation for Biomedical Research. The poster above is…