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The investigators, other than the people at Merck, didn't know about [additional cardiovascular adverse events] for six months after the study was published. But one could argue we didn't have to know because it's not part of the predefined study.

I've just returned from Europe, where I spoke with various think tanks, thought leaders, and pharmaceutical companies on the issue they call "information-to-patients" (ItP). That's what we on the other side of the pond refer to as direct-to-consumer communications. In Europe, they choose to abstain from using the "A" word-advertising. But rhetoric counts. "Information to patients" seems quite paternalistic when compared with the new-worldly "direct-to-consumer" moniker.

In february, local news papers in the United Kingdom reported on disciplinary judgments made by the Association of the British Pharmaceutical Industry (ABPI) against four pharma manufacturers. The disciplinary actions consisted of public reprimands for three companies, and suspension from the association for at least six months for the fourth company.

The key is distinguishing between what the reps know with confidence versus what they will forget.

Changing Landscapes: A Special Report on the World?s Top 50 Pharma Companies

Pharma should comply with PDRP. If the program fails, a likely result is state legislation that proves even more restrictive.

Just how traditional marriages join a couple together from a common culture, Daiichi and Sankyo are merging based on a sense of having come from the same place, and facing the same future. But the art of integration lies in creating new ways of working that make the marriage bigger than the sum of its parts. Officiating the marriage is John Alexander, MD, head of pharma development for Daiichi Sankyo.

A new study details the physiological reasons why COX-2 inhibitorsincrease the risk of heart disease. Suppressing the production of one key fact does reduce pain, but it also deprives the body of a mechanism to curb blood clots, resist artery hardening, and regulate blood pressure.

During the past two weeks, companies from a half dozen states and three foreign lands joined forces. Here?s an update on who?s working with whom.

Challenges of business...

achema product profiles

innovex

Elsevier Launches Inteleos Drug Tracking and Analysis Tool

marketRx sets up European Headquarters in Reading, UK

Industry experts weigh in on what could be the resolution of a long saga.

Psychiatrists offer insight on the second phase of results from a National Institutes of Health study comparing different anti-psychotic drugs.

Drug companies can do to specialists what Intel did to PC box makers: commoditize them.

High-deductible health plans go against the goals of employers, pharma, and the public.They don't reduce out-of pocket drug costs.

Big Pharma now has a powerful competitor. If firms want to have a sporting chance in that war, they need to think about why biotech is so appealing.

It's not closing time, but it does seem like the nine-year, direct-to-consumer (DTC) advertising happy hour is winding down. PhRMA's new Guiding Principles are dimming the lights, and television, the most glamorous and visible media channel for DTC, will have to turn down the volume.

The blockbuster era is at an end. Drugs are focused on smaller audiences today. With fewer doses to run, we must be flexible to support multiple molecules.

In 2005, healthcare advertising hit a new level of refinement in strategy and sophistication in execution. Even better, it reached a new place, where promotion and education sit comfortably together. Brand teams are growing and learning, particularly about using emotion to inspire action.

Safety advocates want to make it tougher for new drugs to win FDA approval. Consumer advocates want to make it legal to import drugs from abroad. Put those ideas together, and what have you got?

Most reps' best opportunities to gain a physician's time and attention come when they are new to a territory, or when the products they promote have a new indication.

So-called "consumer-driven" health insurance is designed to help informed consumers make better decisions about their medical treatment. But the high deductibles associated with these plans are affecting the end goal.

Meetings at which peripheral activities become the focal point are likely to attract scrutiny.

A new study indicates that a protein produced by HIV invades uninfected B cells and inhibits a mechanism that makes certain antibodies very good at targeting invading agents.

Experts say proposed label changes or black box warnings would not significantly decrease ADHD drug prescriptions. But they see potential market opportunities for new products and generics.