Did Big Pharma team up to kill British Columbia's drug safety watchdog?
Was the provincial government pressured by deep-pocketed pharmaceutical conglomerates to kill off the Therapeutics Initiative, an internationally acclaimed drug watchdog agency run out of UBC?That theory may sound like an outlandish plot from a Hollywood movie, but it gained some credibility during this spring’s provincial election when it was raised by NDP leader Adrian Dix.He said the “influential” pharmaceutical industry, which donates to and lobbies the B.C. Liberals, incessantly pressured the government to shut down the Therapeutics Initiative (TI).The TI is a small agency of university scientists who study the ...
Source: PharmaGossip - July 13, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
The Last PPAR Compound?
Roche has announced that they're halting trials of aleglitazar, a long-running investigational drug in their diabetes portfolio. I'm noting this because I think that this might be the absolute last of the PPAR ligands to fail in the clinic. And boy howdy, has it been a long list. Merck, Lilly, Kyorin, Bristol-Myers Squibb, Novo Nordisk, GlaxoSmithKline, and Bayer are just the companies I know right off the top of my head that have had clinical failures in this area, and I'm sure that there are plenty more. Some of those companies (GSK, for sure) have had multiple clinical candidates go down, so the damage is even worse tha...
Source: In the Pipeline - July 11, 2013 Category: Chemists Tags: Drug Development Source Type: blogs
Castellani vs Goldacre
Are clinical trial data shared sufficiently today? YesThe AllTrials campaign asks for all trials to be registered and their results published. Ben Goldacre (doi:10.1136/bmj.f1880) says we need the evidence to make informed decisions about medicines. John Castellani says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the informationClinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients. Biopharmaceutical companies are committed to the conti...
Source: PharmaGossip - July 9, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Drs. Oz & Roizen's Tip of the Day: What's up with Avandia?
Q: I have type 2 diabetes, and three years ago I stopped taking Avandia because the Food and Drug Administration labeled it a heart-attack risk. Now it's OK'd by an FDA panel. Is it safe?JOLENE P., AtlantaA: Good question. After the drug rosiglitazone (Avandia) was approved for sale in the U.S. in 1999 there were questions about its safety. So the manufacturer asked Duke researchers to conduct the RECORD study. The FDA then had the pharma company arrange with Duke Clinical Research Institute to re-examine that data.But in the meantime, back in 2007, Dr. Steve Nissen, chair of cardiovascular medicine at the Cleveland Clinic...
Source: PharmaGossip - July 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Final June Diabetes News Snippet Post
Jennysaid... The FDA is taking another look at Avandia's relationship to heart disease. http://www.forbes.com/sites/matthewherper/2013/06/04/battleground-fda-how-tomorrows-avandia-panel-could-help-shape-the-future-of-diabetes/But whatever they conclude about whether or not Avandia causes heart attacks, we know that it, like Actos, also weakens the bones over time and makes them prone to fracture, since it converts that stem cells that should become bone cells into baby fat cells.It, like Actos, also raises the chances of experiencing retinal edema--swelling in the blood vessels in your eye that can contribute to blindn...
Source: Diabetes Update - July 3, 2013 Category: Diabetes Authors: Jenny Source Type: blogs
Tamiflu saga continues - NYT. By Katie Thomas
Breaking the Seal on Drug ResearchPETER DOSHI walked across the campus of Johns Hopkins University in a rumpled polo shirt and stonewashed jeans, a backpack slung over one shoulder. An unremarkable presence on a campus filled with backpack-toters, he is 32, and not sure where he’ll be working come August, when his postdoctoral fellowship ends. And yet, even without a medical degree, he is one of the most influential voices in medical research today.Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companie...
Source: PharmaGossip - June 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Aspirin unneeded with anticoagulation/clopidogrel after MI, PCI in AF; vegetarian diet linked to longer life; FDA: Rosiglitazone does not up CV risk; New obesity drug, lorcaserin
(Source: Blogs@theHeart.org)
Source: Blogs@theHeart.org - June 14, 2013 Category: Cardiology Authors: theheart.org Tags: This week in cardiology from heartwire Source Type: blogs
Diabetes Drugs Under Scrutiny As FDA Considers Another Study
As a two-day NIH workshop gets underway to examine the safety of several widely used diabetes drugs, the FDA is considering whether to run a study to determine whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that have generated considerable controversy.
“A review of FDA-required epidemiological studies submitted to (the FDA) have provided conflicting results and do not provide reliable evidence to refute or support a causal link between GLP-1 based therapies and risk of acute pancreatitis,” wrote Solomon Iyasu, who heads one of the FDA e...
Source: Pharmalot - June 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
GlaxoSmithKline Fires China R&D Boss for 'Misrepresented' Data
Published: Tuesday, 11 Jun 2013 | 6:35 PM ETBy: Dan Mangan | WriterGlaxoSmithKline has dismissed its head of research and development in China after an email tip prompted an investigation that determined data used in a 2010 research paper were "misrepresented," the company said.The drugmaker also accepted the resignation of a co-author of the paper on multiple sclerosis, which was published in Nature Medicine, and placed three other employees in China on administrative leave pending a review.GSK now wants the disputed paper, which dealt with the possible role of the molecule interleukin-7 as a risk fa...
Source: PharmaGossip - June 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
GSK Trading Sluggish on Avandia Saga
Around ASCO time GSK was a promising stock being touted by life science investors as one of those undervalued stock that you can go both long and short. Even with the Avandia scandal going on, you’d think that GSK is almost invincible. Except it isn’t. Headlines around Avandia still dominates investor consciousness and even though [...] (Source: NAKEDMEDICINE.COM)
Source: NAKEDMEDICINE.COM - June 10, 2013 Category: Health Medicine and Bioethics Commentators Authors: Jane Chin Tags: Science and Research Source Type: blogs
Top stories in health and medicine, June 10, 2013
Brought to you by MedPage Today.
1. Low Vitamin D Linked to Hepatitis B. Vitamin D deficiency might be a key player in hepatitis B (HBV) replication.
2. Wrinkles Emerge in SGR Repeal Debate. As Congress inches toward a change in the way physicians are paid under Medicare, an early-stage Republican proposal drew criticism this week for not going far enough.
3. Avandia’s Future Still Bleak? An FDA panel recommendation to loosen restrictions on the controversial diabetes drug rosiglitazone (Avandia) isn’t likely to affect how — or whether — doctors prescribe it.
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Source: Kevin, M.D. - Medical Weblog - June 10, 2013 Category: Family Physicians Tags: News Diabetes Endocrinology GI Source Type: blogs
To Ease Or Not To Ease: FDA Panel Votes To Loosen Avandia Restrictions
After an intense two-day meeting that illustrated the challenges in determining drug safety, a divided FDA advisory panel voted to ease restrictions on the use of the controversial Avandia diabetes pill, which has been under the equivalent of regulatory lock and key for nearly three years.
Of the 26 panelists, 20 voted to either remove or somehow modify the existing REMS, or Risk Evaluation and Mitigation Strategy, which was established in 2010 following a protracted controversy over the extent to which the GlaxoSmithKline drug causes serious cardiovascular events. That debate emerged after a 2007 meta-analysis found a 43 ...
Source: Pharmalot - June 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Advisory Panel Backs Looser Restrictions On Avandia
After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. One member (the consumer representative) voted for the withdrawal of rosiglitazone. By contrast, 20 members voted to either modify (13 votes) or remove (7 votes) the REMS. But the vote should not be interpreted as a broad statement by the More… (Source: CardioBrief)
Source: CardioBrief - June 6, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Avandia Duke University FDA food and drug administration GlaxoSmithKline Rosiglitazone Source Type: blogs
