Letter from the Editor

Contributed by:

Taren Grom, Editor

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

Ringing in a new year of change

Taren Grom, Editor of PharmaVOICE, and Mary Alice Raudenbush, VP of Regulatory Affairs at Endo Pharmaceuticals, share a moment during the recent HBA Leadership Conference in Baltimore, the focus of which was becoming an agent of change.

HBA Leadership Conference

Ringing in the new year is a time for reflection and with so many pressing issues facing life-sciences companies, business in 2006 is sure to be anything but usual. In 2005, the industry weathered myriad storms — ranging from major product withdrawals to threats of pandemics to more government controls to increased scrutiny on drug safety and efficacy to the initiation of a complex reimbursement program to billions of dollars in sales lost to patent expirations, and the list goes on and on — all under a cloud of public distrust. Yet, despite the highly visible critics who took advantage of every consumer media outlet to spew their own agendas and denigrate an industry that often doesn’t receive the credit it deserves, there remains a sense of optimism and a renewed focus on the patient, particularly the baby-boomer patient population. More than 900 new medicines are in development to treat the diseases of aging, according to a report released in December 2005 by the Pharmaceutical Research and Manufacturers of America (PhRMA). These new medicines include 146 drugs for heart disease and stroke and 399 for cancer. Alzheimer’s disease alone could afflict 16 million people by the middle of this century unless a cure or new treatments are found; research-based pharmaceutical companies are currently developing 27 medicines to treat it. (See related story on page 18.) Nineteen medicines are being researched to treat depression, which affects about 6.5 million Americans 65 years old and older; 48 for diabetes, of which half of all cases occur in people older than age 55; 20 for osteoporosis, a major health threat for almost 44 million Americans age 50 and older; and 17 for Parkinson’s disease, 60,000 new cases of which are diagnosed each year. Other medicines in development target bladder and kidney diseases, eye disorders, gastrointestinal disorders, osteoarthritis, pain, prostate disease, respiratory and lung disorders, rheumatoid arthritis, skin conditions, and other conditions of aging. The industry is redirecting its focus more squarely on the patient with more patient-education programs and movement away from “traditional” direct-to-consumer efforts. More effort is being spent on Phase IV trials to evaluate safety issues in large and diverse patient populations. Billy Tauzin, PhRMA president and CEO, summed it up best during a recent keynote address in Philadelphia. “To many outside the pharmaceutical industry, the concepts of industry success and meeting patients’ needs seem incompatible,” he said. “Haven’t we all heard in countless focus groups around the country that we’re greedy, heartless, and make too much money? But the truth is that we are — as an industry — focused on one thing: the patient. Granted, we’re a business — a pretty darn big business. But we’re a business of people working for people. We make lives better through better health … We face a challenge. How do we move forward and continue to meet the industry’s need to sustain the investment necessary for continued innovation while balancing that with patients’ needs now and in the future? The key is promoting a free market that inspires and rewards both innovation and change. And I’m convinced we can accomplish this in three important steps — all with the patient in mind. First, we must listen. Second, we must educate. And third, we must deliver.” These three steps are sure to be the center of many discussions. Already many groups are adopting change as the theme of their conferences. For example, during the Healthcare Businesswomens’ Association’s Leadership Conference last November, numerous panels and workshops delved into the event’s theme: Becoming an Agent of Change. (See related story on page 26.) Taren Grom Editor PharmaVOICE January 2006 Letter from the Editor

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