Hello, everyone, and nice to see you again. We hope the holiday break was filled with fun and relaxation. Now, of course, the usual routine of meetings and deadlines has resumed. You knew it would come to this, yes? To cope, we are brewing a few cups of mandatory stimulation. We invite you to join us. Meanwhile, we have assembled a laundry list of interesting items that emerged in recent days to help you get caught up. Hope your day goes well...
Aveo Kidney Cancer Drug Data Disappoints (Reuters)
Use Of Stress Meds Correlates With Unemployment (Bloomberg News)
FDA Approves Pfizer's Prevnar Vaccine For Adults (Reuters)
Roche's Garaud Discusses The Pipeline (Star-Ledger of New Jersey)
New Painkiller Has Abuse Experts Worried (Associated Press)
HIV Vaccine Gets Approval For Human Trial (Economic Times)
Glaxo CEO Andrew Witty Is Knighted (The Telegraph)
Roche's Avastin Fails In Ovarian Cancer Study (MarketWatch)
Ben Venue Extends Manufacturing Shutdown (Outsourcing Pharma)
GE Healthcare To Pay $30M In False Claims Suit (Detroit Free Press)
Doctors And Pharma Officials Caught In Rebate Scheme (Korea Herald)
Celgene Hires NJ Gov's Chief Of Staff (Bloomberg News)
India To Seek Greater Generic Drug Market Access In Japan (Economic Times)
ADHD Drug Shortage Forecast To Continue (Reuters)
Lundbeck Buys Ossianix For Nervous System Treatments (Pharma Times)
Glaxo Presses Plans For Wind Turbines, Despite Protests (The Telegraph)
Chantix Testing Continues Despite Side Effects (Philadelphia Inquirer)
Woman Sues Cough Syrup Makers For Marketing To Kids (The Province)
Synthes Accuses Stryker Of Raiding Reps, Taking Secrets (Bloomberg News)
J&J And Bayer Seek A New Use For Xarelto Bloodthinner (Associated Press)
Takeda Actos Cancer Suits Combined In One Court (Bloomberg News)
Pfizer Sues Indian Pricing Authority Over Benadryl Price Cut (Economic Times)
New Law Creates Confusion Over Reimbursement In Poland (Warsaw Business Journal)
EDITOR’S NOTE: Please check this post for updates throughout the morning
4 Comments
Welcome back, Ed, and may I observe that you do seem to have been keeping up on your reading?
The Avastin situation in ovarian cancer follows what Merrill Goozner posted about the late Head of the Italian Cochrane Network, Alessandro Liberati. In a recent letter to The Lancet, Liberati noted that only 58 out of 1384 studies on multiple myeloma was overall survival an endpoint, and in only ten of these was it the primary endpoint.
Again, like in Avastin-based therapies in breast cancer, the final arbiter of clinical approval - overall survival - has not met statistical significance. Progression-free survival does not address the patient's quality of life during what little additional months of some serious side effects a number of women experiences.
In one study from the U.S., nearly 1900 women with advanced ovarian cancer were studied. Half received standard chemotherapy and the other half got Avastin in addition to the chemotherapy. It took a little longer for the cancer to progress in the Avastin group, but after four years just as many (a little over half) of the patients who received Avastin had died, as did patients who did not get the drug.
In the other study, done in Europe, over 1500 women with ovarian cancer were studied and had the same results. The cancer took a little more time to progress in the women given Avastin, but after 3 years, the groups had equal numbers of deaths.
The rationale underlying the use of anti-angiogenesis drugs against ovarian cancer is that (1) VEGF pathways are strongly associated with the development of malignant ascites, malignant pleural effusions and carcinomatosis, and (2) both VEGF receptors and VEGF ligands can be over-expressed in ovarian cancer.
If the anti-angiogenesis drugs work the way they are supposed to work they block the activity of VEGF, to prevent the growth of new capillaries into the tumor and thereby sustain tumor growth. Perhaps Avastin "sensitive" tumors secrete relatively low levels of VEGF. Tumors which secrete relatively low levels of VEGF might be more susceptible to an agent which works by blocking VEGF.
What this may mean is that blocking blood vessels with a drug like Avastin, though a great concept, isn’t the answer to ovarian cancer.
I understand that Andrew Witty has just signed a contract to join an oldies touring R&B singing group-Otis Day and the Knights.
Makes me wanna shout!
http://www.youtube.com/watch?v=IqXwA5vxTt4
Hi Ed, Welcome back from vacation. Hope that you had a chance to relax and get some quality time in with the Pharmalots.