Pharmalot... Pharmalittle... Good Morning

Rise and shine, everyone, another busy day is on the way. As usual, we are scrambling to get the short people to their schoolhouses and encouraging the official mascots to fertilize the budding weeds as quickly as possible. This takes perseverence and, you guessed it, a cup or three of stimulation. Please do join us. There is no need for us to drink alone. Meanwhile, we must get on with planning our week, which includes a raft of meetings. So here are some tidbits to get you started. Have a grand day and stay in touch...

FDA Halts Amgen Trial After Teen Death (Reuters)

FDA Rejects Dynavax Hepatitis B Vaccine (Reuters)

UK To Change Patent Law For Clinical Trials (The Telegraph)

India To Decide Bayer Appeal On Compulsory License (PharmaBiz)

FDA Expands Approval Of Bayer Cancer Drug (Associated Press)

Cancer Drugs Are Showing Value Earlier In Testing (Reuters)

Pfizer Plans More Alliances In China (Dow Jones)

Death Toll Rises In Meningitis Outbreak (The Tennessean)

Vivus Diet Pill Sales Hindered By Reimbursement (Pharma Times)

Genentech May Hire 600 Employees This Year (CBS News)

New Zealand Probes Charges Of Price Fixing (New Zealand Radio)

EDITOR'S NOTE: Please check this post for additonal items during the day

3 Comments

Feb 26, 2013 - 12:51pm
In regards to the FDA expanding approval of the Bayer cancer drug, one wonders about modern therapies and their real impact upon cancer outcomes. While most of the attendees at the ASCO trade show were considering how the newest VEGF inhibitor Stivarga (regorafenib), might impact their practices, some attendees were somewhat underwhelmed by the results of this statistically significant, but clinically marginal survival advantage, associated with great expense.

Members of AACR (American Association of Cancer Research), the basic science organization, ponder deep biological questions. Their spin-offs arrive in the hands of members of ASCO as Phase I and Phase II trials, some of which are then reported at the ASCO trade show. Many of the small molecules that have been studied over the years are now slowly making their way to clinical therapy.

One comment about the trial was that Stivarga (regorafenib) targets C-Kit, VEGFR, PDGFR, RET, RAF-1, BRAF, p38 MAP and a bunch of other kinases. Those hoping to come away from the ASCO presentation with news of a dramatic breakthrough were disappointed. Unquestionably, some patients will do very well on this drug. Whether the median progressive-free survival (PFS) can be further improved, and overall survival (OS), remains to be seen.

Is it possible that effective treatments for cancer are already at hand? Lacking the tools to decipher the signals and combine agents to the greatest effect, are we destined to continue to administer increasingly expensive, toxic, yet arguably no more effective therapies? With the myriad of drugs and combinations available today, might it be that we cannot see the forest for the trees?

Feb 27, 2013 - 8:35am
New link for Reuters story

http://www.reuters.com/article/2013/02/25/cancer-drugs-idUSL1N0B6GQO20130225

The suggestion that this is "personalized medicine" falls flat when one realizes that a good outcome is nothing more than a chance event. The cancer research community's single-minded focus on genomic platforms forces patients to continue to participate in randomized trials to test hypotheses of interest to the investigators, largely at the expense of the patients in need.

The trial is, at its core, a randomized selection of candidates. While it may enable investigators to interrogate answers to scientific questions of interest, it does so with no immediate benefit to the patients who participate. Patients who gain benefit (after being randomized to the investigational arm and then receiving a new drug that actually works) receive said benefit by what could best be described as blind luck.