Pharmaceutical Executive, Jan 1, 2005

Executive Profile

Bold Bets

By L.J. Sellers

From its origins as a small company making reproductive hormones to its current status as market leader in multiple sclerosis, Serono has always done things in a big way. The company created the infertility market with two early products: Pergonal (menotropins), used for the in vitro fertilization (IVF) of the first test-tube baby, and Profasi (chorionic gonadatropin), collected from the urine of 100,000 postmenopausal women. Serono later boldly put its MS drug Rebif (interferon beta1a) up against Biogen's Avonex, a similar interferon, in a head-to-head trial and proved Rebif's superiority.

Features

The Year Payers Stopped Threatening

By Michael Russo , David Balekdjian

Citing cherry-picked patients, unrealistic dosing, and placebo control, payers will increasingly require that the proof for payment of drugs must come from head-to-head trials.

In Sales We Trust

By Michele Goldberg , Bob Davenport

The average salary for all levels of pharmaceutical reps is $62,400 with another $19,300 in cash bonuses, up from a base salary of $53,800 in 2001.

The Future of Labeling

By Sarah Powell , Greg Kalten

Say good bye to PDF and Word files. Over the next few years, FDA and European regulators will require regulatory submissions in new XML-based formats. The change will be a challenge for companies—but it offers many rewards. // The first hurdle: The Structured Product Labeling Initiative. Here's what you need to know.

From the Editor

The Other Vioxx Scandal

By Patrick Clinton

It's hard to believe that patients and doctors could read Vioxx's prescribing information and not ask some serious safety questions. Why didn't they?

Washington Report

Rough Road Ahead

By Jill Wechsler

On Capitol Hill, the powerful Senate Finance Committee is taking a renewed interest in drug regulatory issues, as Congressional leaders plan investigations and hearings on industry practices and the "lax" FDA.

World News

Filling the Gaps

By Sarah Houlton

Heading the WHO list are pandemic influenza and antibiotic-resistant bacterial infections. Together the two could kill millions.

Columns

Marketing to Professionals: MSLs: Off-Label Promotion

By Jane Chin, PhD

Managers may ask MSLs to "see what they can do" for their sales colleagues if product sales have dropped. This is a huge problem, especially in companies where 360-degree feedback is a favorite measuring tool.

Sales Management: The Education Equation

By Preston Dodd

Pharma spent $11.2 billion in 2002 to hire and employ reps but only $150 million on knowledge transfer. They train reps to serve as their "face," but they don't keep them current on the evolving medical dialogue.

Alternative Media: Websites that Click

By Sandra Holtzman

Companies still haven't mastered how to develop sites that speak to their audiences' needs.

California Compliance

By Jesse Witten , Toni-Ann Citera

Now through July 1 pharma and device companies should assess their operations to identify whether any additional internal controls are necessary to comply with the new California statute.

Back Page: Vioxx Populi

By Peter J. Pitts

A congressional inquiry, a disgruntled whistle blower, the press smelling blood in the water, tort lawyers throwing blood in the water. What do they add up to? And does it really make patients safer?

Research Goes Global

Consolidation among market researchers is all well and good, but how is it creating value for pharma?