Lexicillin QD

Pharm quick links

Hyperactivity drugs to be studied for heart risk from Bloomberg online. The FDA has forced manufacturers of ADHD meds to provide warnings of possible heart risks, some due to possible structural heart defects. I wonder if there is a problem with those children who have hypertrophic cardiomyopathy, or if it's every been considered.

Novartis says new study data shows efficacy, tolerability of Galvus from Forbes online. A clinical trial involving subjects with type 2 diabetes showed that those taking Galvus (vildagliptin) in addition to metformin were four times more likely to achieve their HbA1C goals. The findings for this DPP-4 inhibitor (incretin enhancer) were presented at the European Association for the Study of Diabetes meeting. The FDA issued an approvable letter for the drug this past February, while an EU committee had a positive report recommending authorization.

Celera enters oncology research collaboration with Merck to develop pharmacogenomic tests from a Celera presss release;

Celera will evaluate the use of certain gene expression profiles identified by Merck with the goal of developing diagnostic predictors for use in Merck’s clinical trials, and to potentially form the basis for commercial companion diagnostic tests for oncology therapies.

The flip flop rhythm of epidemiology

I think you can subtitle this post "The weakness of observational studies versus the randomized clinical trial (RCT)."

Do We Really Know What Makes Us Healthy? is the cover story by Gary Taubes published in yesterday's NY Times' magazine about the utility of epidemiology in providing the public with guidelines for maintaining health.

He starts off by talking about the hormone replacement therapy (HRT) controversy where HRT was supposed to prevent heart disease supported by observational studies. Then in the 90s, HRT was generally recommended for all women, but it was only was randomized clinical trials, such as WHI and HERS, looking at secondary and primary prevention respectively, that showed that HRT is not heart protective.

The point is women who take HRT are a special population, with unquantifiable characteristics, that tend to bias an observational study. You never know what you can miss, Taubes says. This confounding variables are better managed with a RCT. It also what's needed in attempting to prove causality.

I try to follow this up with further discussion.

UPDATE: The WSJ has an article published today Report Sheds Light on Hormone Therapy which suggests a reason why HRT might not have the cardioprotective effect for some women.

Researchers at University of Texas Southwestern Medical Center in Dallas have discovered that a compound related to cholesterol can block the hormone estrogen from performing functions in blood vessels that keep them healthy and free of disease that can lead to heart attacks.

This team found a molecule called 27-hydroxycholesterol, or 27HC, which is a byproduct created as the body processes cholesterol. The found in mice that 27HC and estrogen target the same receptors in blood vessels.

Following this hypothesis, premenopausal women are protected by the high levels of estrogen and low levels of 27HC, but during menopause, therapeutic estrogen is not effective because it can't compete with 27HC.

The researchers claim that this could account for the results found in the above-mentioned WHI and HERS studies.

Hillary care will cost $110 billion and will mandate coverage

She'll be making an official announcement in Iowa today, but from what I'm hearing it will mandate that everyone have a health insurance plan. This is certainly not a single payer plan, and it's a step back from government involvement that was proposed in her plan back in '93.

This sounds like the plan Romney instituted in Massachusetts, but he has said that he wouldn't want to implement something like this nationwide.

The Hillary plan is supposed to analogous to mandatory car insurance, but I don't think they can have punitive actions against those who don't have coverage and must have emergency treatment.

The NY Times online has a special section entitled Health Insurance and Managed Care.

Viagra, fish oil or Lipitor?

These were the options in the poll question "What is the one pill you can't live without?" posted on the boomer social media site TBD.com, which I heard about this morning on NPR. Their tag line is "Sharing Experience to Thrive."

It is based out of San Fran, and is following the social media fad, this time for an older crowd that just wouldn't seem to fit in with the MySpace site. Facebook is increasingly being populated by the oldersters, but is becoming unwieldy with a population of 40 million and continued rapid growth.

In the coming days, I'll see how much TBD is borrowing from the functionality of Facebook from which I recently unsubscribed.

Tangerine peel compound investigated as possible cancer therapy

Salvestrol Q40 is the compound derived from the tangerine peel, and it has been shown to inhibit the enzyme P450 CYP1B1, found in human cancer cells.

This topic is being presented at the British Pharmaceutical Conference.

The P450 enzymes are part of cytochrome systems, usually involved with electron transfer and metabolism. The "P450" refers to the heme pigment which cause at 450 nm with absorption spectroscopy.

Tangerine peel could help fight cancer | Health | Reuters

Technorati Tags: salvestrol, cancer, p450, tangerine

Novartis using share buybacks to float stock price; dire reports on Prexige and Galvus

[Novartis] is going to spend up to 100% of its free cash flow after dividends and acquisitions on share buybacks in an effort to keep the stock price up. Its previous target for buybacks was up to 50%.

"If you want my personal opinion, I don't expect we'll get approval," says Novartis chief Dan Vasella about his Cox-2 inhibitor Prexige. Along with, "We had a significant number of disappointments."

This comes up top of news that Galvus won't be resubmitted to the FDA until 2009. At one point it looked as if Novartis would beat Merck to market with the first incretin inhancer. Now, Merck's hot selling Januvia has no competition in this drug class.

Health Blog

Technorati Tags: Novartis, Galvus, Prexige, Vasella

Adam Bosworth leaves Google Health

The WSJ Health Blog is reporting that Adam Bosworth, on vacation at the moment, "has decided to pursue other opportunities after that" according to a spokesman at Google.

The were hints that Google might enter the EMR field, based upon Bosworth's talk earlier this spring.

Health Blog

Technorati Tags: Google, healthcare

SciVee alpha: the video-sharing community for science topics

Associated with the PLoS, SciVee was developed by Philip Bourne, a pharmacology professor at UCSD, to allow the sharing and tagging of user-generated video.

SciVee: Pioneering New Modes of Scientific Dissemination | Pioneering New Modes of Scientific Dissemination

Technorati Tags: plos, Scivee

Researcher Clifford Rosen challenges the FDA approval process

He's saying that not only should drugs show efficacy with the surrogate markers, such as A1C with the type 2 diabetes meds, but they should also be proven to "enhance long-term quality of life by reducing risks for such serious
side effects as heart attacks, eye and kidney ailments, and amputations."

His opinion, based on his experience as chair for an FDA advisory panel considering Avandia heart risks that emerged eight years after FDA approval, was published as a commentary in the NEJM

Burden of proof - The Boston Globe

Technorati Tags: Rosen, FDA, nejm

Alnylam & Isis = Regulus

Link: WSJ Health Blog : Old RNA in New Bottles?

This is about the announcement that Alnylam Pharm. and Isis Pharm., both big players in the very hot field of RNA interference (RNAi), are launching their joint venture called Regulus.

RNAi is a natural process of gene silencing. The cell uses microRNA (miRNA) to stop the production of protein encoded by a particular gene. In the case of cancer, oncogenes can overcome this inhibition, producing a glut of disease-causing proteins.

The level of naturally occurring miRNA can be raised to help control cancer, or synthetic short interferring RNA (siRNA) can be created for the same purpose.

They've brought in the CalTech Nobel laureate David Baltimore to sit on the board and chair an advisory group.

These companies have a history of collaborating on miRNA technology. Since 2004, they've jointly licensed IP relating to the therapeutic uses of miRNA from the Max Plank society.