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Washington, DC-More countries are hosting pharma's R&D efforts, creating a research environment ripe for abuses of patient safety because FDA cannot ensure the same protection in foreign trials as in domestic ones. A recent study by the US Health and Human Service's office of the inspector general (OIG) found that regions with less research experience-including Eastern Europe, Latin America, and East Asia-have become more desirable locations for US-based companies and contract research organizations' clinical trials. In fact, the number of countries producing data for FDA submissions jumped from 28 to 79 between 1989 and 1999. And that trend shows no

Tokyo, Japan-European pharma industry leaders have called for the opening of the Japanese market through measures to promote greater innovation there. The demand followed a European Federation of Pharmaceutical Industries and Associations' visit to Japan led by EFPIA president Jean-Frany}ois Dehecq, chairman and CEO of Sanofi-Synthelabo.

Washington, DC-Pharma companies suffered a significant setback last month when developing countries at the World Trade Organization meeting pushed through a declaration allowing nations to override patent laws to cope with health crises. Although industry officials insisted that the agreement would have little impact on profits, the language sets the stage for more competition from cheap generic products in much of the world.

Brussels, Belgium-Pfizer believes the dual pricing system it introduced in Spain complies with Spanish and European Union competition laws, but the European Commission isn't so sure. Competition policy commissioner Mario Monti says the EC will scrutinize Pfizer's pricing policy, which is intended to prevent parallel trade out of low-cost Spain.

It all started because of a commitment I made when I was too young to understand what I was getting myself into. My mother had headaches. Not "throbbing in the temples" headaches, but gut-wrenching, totally incapacitating, "rip the carpet out with your bare hands" headaches. Migraine, cluster headache, trigeminal neuralgia-whatever the flavor, they were really bad. She saw practically every specialist in the country. They gave her ergotamine injections until her fingers turned blue, narcotics powerful enough to stop a charging elephant, and dozens of other medications, many of which were experimental at the time. Nothing worked.

London, UK-Insurance companies will be unable to use genetic test results to approve or deny claims for at least the next five years, following a new agreement between the British government and the Association of British Insurers. The move ensures that people can still get insurance coverage whether or not they have had a test.

Transfusion centers used to throw plasma away as though it were extraneous liquid, keeping only the red blood cells. During World War II, researchers discovered that the fluid left over after the red cells had been spun free contained vital proteins, and biochemist Edwin Joseph Cohn developed a method for their large scale extraction. Over the years, the scrutiny of plasma produced many new proteins that could be processed and used as life-saving medical treatments for rare blood diseases like hemophilia. Plasma fractionation is now a $6.5-billion-a-year business and more than a million people receive plasma therapeutics annually.

Washington, DC-To improve FDA's ability to respond to terrorist attacks, acting commissioner Bernard Schwetz tapped Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), to establish a formal crisis management program for the agency. Woodcock moved to the commissioner's office in November to develop a program to better track and coordinate FDA responses to terrorism.

The computing power of today's PC enables marketers to conduct analyses that were unthinkable just a few years ago, creating exciting new ways to approach and track promotion response. This article describes a novel approach that models promotion response at the individual physician level.

York, UK-Pharma companies have failed to prevent product counterfeiting, and experts warn that the industry-wide security body has no coordinated approach to help.

Americans appear to be increasingly satisfied with the healthcare they are receiving, the costs they are paying for healthcare, and their managed care plans, according to the 2001 Health Confidence Survey released by the Washington-based Employee Benefit Research Institute. However, as past HCS results have shown, many Americans continue to be pessimistic about the future of the nation's healthcare system, about their future ability to choose the doctors they want and about their ability to afford prescription drugs.

A rep's guide to retirement investing.

New York-based Bristol-Myers Squibb Co. and Cincinnati-based Procter & Gamble Co. made the top ten in Working Mother magazine's 16th annual list of the "100 Best Companies for Working Mothers," a compilation of corporations that best recognize the value and needs of working families.

Despite the fact that the U.S. antidepressant market grew at a 20% annual rate between 1995 and 2000, the loss of patent exclusivity of selective serotonin reuptake inhibitors - beginning with Indianapolis-based Eli Lilly and Co.'s Prozac® (fluoxetine) last August - will likely cause the market for SSRIs and similar drugs to decline for the first time in over a decade, according to Decision Resources Inc., Waltham, MA. Also, novel therapies now under development for depression face greater challenges than previous treatments did.

The nuances of etiquette for business dining.

Pharmaceutical reps want a share of the one thing doctors have very little of: their time. Here's how to get it

New York-based Bristol-Myers Squibb Co. announced that its $7.8 billion acquisition of Wilmington, DE-based DuPont Pharmaceuticals Co. from DuPont is complete. The acquisition, which was announced on June 7, closed on October 1.

The Office of Inspector General for the United States Health and Human Services Administration plans to evaluate the extent of pharmaceutical sales representative gift-giving in 2002, according to its recently released "Fiscal Year 2002 Work Plan."

In response to recent anthrax attacks on the media and the U.S. Senate, U.S. Health and Human Services and West Haven, CT-based Bayer Corp. have reached an agreement for a significant new federal purchase of the antibiotic Cipro™ (ciprofloxacin) at a substantially lowered price. The antibiotic is expected to be available by the end of 2001 and would be used to supplement existing emergency stockpiles for use in the event of a bioterrorist attack.

Most presentation mistakes made by representatives in the field are elementary and may be easily avoided.

The Internet has become a new meeting place for drug companies and doctors, according to the Physician Meeting and Event Audit from Newtown, PA-based Scott-Levin. From February through April 2001, Scott-Levin surveyed its PMEA panel every month to determine the extent of "e-event" activity. More than 3,100 physicians participated in the study; 39% indicated that they had been invited to at least one pharmaceutical company-sponsored event conducted via the Internet.

New medicines in the pipeline for Alzheimer's disease, osteoporosis, arthritis and Parkinson's disease are among the many promising treatments in development for diseases of aging, according to a new survey released by the Washington-based Pharmaceutical Research and Manufacturers of America.

Relatively small numbers of American physicians are using electronic records or prescribing, and the United States lags behind other English-speaking countries in this regard, according to a survey of physicians conducted by Rochester, NY-based Harris Interactive for the Harvard School of Public Health and the Commonwealth Fund's International Health Care Symposium in 2000. The survey found that the use of electronic systems is much more advanced in Britain, New Zealand and Australia than in the United States. The numbers for Canadian usage were low, however, similar to those in the United States.

Taking steps to grow into a well-rounded professional.

Health and Human Services Secretary Tommy Thompson has announced the release of $50 million to fund 94 new research grants, contracts and other projects to reduce medical errors and improve patient safety.

Faced with double-digit healthcare benefit cost increases in 2002, 56% of employers say they will raise employee contributions by as much as or more than their expected cost increases. In addition, more than 70% of employers are considering benefit reductions or an increase in employee co-pays over the next 12 months, according to a survey released by Washington-based consulting firm Watson Wyatt Worldwide.

Life expectancy for the U.S. population reached a record high of 76.9 years in 2000 as mortality declined for several leading causes of death, according to preliminary figures from a report released by the Centers for Disease Control and Prevention.

Government efforts to trim budgets has put the spotlight on unethical pharma marketing tactics.

The September 11 attacks on the United States caused pharma shares to fall along with others, but as investors switched to safe stocks, considered less susceptible to cyclical consumer trends, they rebounded. On September 12, broker WestLB Panmure raised its recommendation of the pharma sector from "neutral" to "outperform," favoring Sanofi-Synthelabo, Novo-Nordisk, Shire Pharmaceuticals, and GSK.

Sampling is a sales rep's foot in the door to doctors' offices and the quickest way to get products into consumers' hands. That's why reps handed out $5 billion worth of the freebies last year, spending 30 percent of companies' promotional budgets in the process. Despite that huge investment, few product managers can assess its impact on product inventory, consumer demand, prescription rates, or market share. But sampling's greatest failure is its inability to provide the healthcare industry with product-use or patient data.