Interesting NY Times Essay

Tom Welch passed this one on to me-I thought it was a pretty interesting essay. We focus a lot of attention on DTC advertising, but the marketing campaigns at PHRMA works through many different avenues. We are used to seeing drug reps at pharmacy meetings and events, but what happens if it's just a doctor giving a talk? This lengthy essay from the NY Times gives one doctor's experience giving drug talks. Here's a brief interview with Dr. Carlat in response to his article, as well as his blog that undermines a lot of what he did as a drug company representative.

Chantix concerns

More FDA stuff...The FDA issued an early communication about the possibility of some possible concerns of erratic behavior and suicidal ideation that is possible with Chantix. Here's some more info on the Pharmalot newsfeed as well that goes into further detail.

Zetia not as good as their marketing plan?

So, Zetia has some pretty nifty commercials and they are awfully scientific looking. But, apparently their actual approach to good science isn't quite up to snuff. Thanks to Dominic for sending the following links-

Here's a New York Times article on the issue questioning their delay in releasing information and changing primary endpoints. For a funny analysis of the topic, check out the Drugmonkey's blog here. **Caution-the Drugmonkey uses language not commonly used in a pharmacy (at least hopefully not used) so those with sensitive eyes, beware.

FDA Conference on Behind-the-counter status

On November 14th, the FDA heard comments from the general public-they are listed here. It's 88 pages long, just to warn you, but if you search for the name "Michael Mone" he spoke on behalf of APhA. He also has some Minnesota ties as well, so that's pretty nifty. Here is a more accessible format of the APhA statement.

I have not yet seen any replies from the FDA or any kind of summary. They are traditionally pretty slow moving, so I wouldn't expect any kind of movement for a while. However, on a slightly related note, Zyrtec is now available over the counter, and Zyrtec-D is behind the counter. As more medications like this are released, with both OTC and BTC status, the third class of drugs is essentially being created. But, will pharmacists take the opportunity to become more involved with their patient's health care when they aren't required to?

MRSA Follow-up

Ahhh, back to our favorite topic-MRSA. As a follow up to the previous post-Andy Behm from Express-Scripts sent a few drugs that are either approved or in the pipeline, as well as a clarification of what "approvable" means in the process.

The most recent drug is Doribax (doripenem) that was approved a few weeks ago for IV use. It falls in the carbapenem class (Remmel is going to get to this soon, so I know nothing on the class as of right now-sorry) but it can be used for complicated intra-abdominal infections and complicated UTI's-so it's effective agains both gram positive and gram negative infections. For further details on what doripenem treats-head here.

The following three drugs that he mentioned are in the "approvable" classification according to the FDA. Andy said that this means that the drug is on the right track towards becoming approvable, and there are a few more things that need to get worked out, like further testing or come up with appropriate labeling. For an interesting discussion on "approvable" letters and how companies respond (and how investors look at the drug development process) head here.

The first drug that falls in this class is the aforementiong televancin-check this one out below. Another drug that is "approvable" is Pfizer's Zeven (dalbavancin). Besides having a sweet brand name-great marketing, Pfizer-dalbavancin works by inhibiting peptidoglycan synthesis and blocking cell wall formation by binding the D-alanyl-D-alanine that is found on precursors of peptidoglycan. For a longer summary of the drug-head here. Also, Pfizer bought the rights to dalbavancin from Vicuron, who first submitted the New Drug Application in 2004.

The third and final drug passed on by Dr. Behm is a drug from Arpida called iclaprim. It works by inhibiting dihydrofolate reductase, and has effectiveness against many different bugs. However, it seems to have met with a critical crowd as evidenced by this article and this one.

As a final note, oh loyal blog-watchers, I wanted to throw this final thought out: When I was looking through these articles, I realized many of the articles didn't discuss the effect and benefit that having more medicines that are effective against resistant strains available and the improvement in treatment this would bring, but on the economic boom that resistant bacteria bring to big PhRMA and their stockholders. As the market share of the treatment of nosocomial infections grows from $10 billion last year to a predicted $40 billion by 2010, it seems that like sharks to blood, drug companies are laboring to bring their drug to market faster and claim a piece of that pie. To see how many companies are looking at this possibility and drooling-look here.