Pharmaceutical Executive-03-01-2002

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GSK in Hot Water

Most people experience at least one event that changes the direction of their lives. For George Rosenkranz-the man who made "the pill" possible-it was a stopover in Cuba. In 1941, he was on his way by boat from Switzerland to a position as a professor of Organic Chemistry at the University of Quito in Equador. But the ship that was scheduled to pick him up in Cuba never came. Pearl Harbor had been bombed, and the world changed. So Rosenkranz-stranded on the island-went to work for a pharma company.

Pfizer's $20 million donation of the long-acting antibiotic Zithromax (azithromycin), which is effective against trachoma with a single annual oral dose, has propelled the worldwide effort against the disease into its second phase

Hard on the heels of the June 2000 announcement that the human genome sequence was completed came a wide array of articles on genomics' impact on drug discovery and development

How quickly the promise of pharmacogenomics and other medical miracles materializes may soon depend more on war-driven politics than science. Only free exchange of scientific information in public arenas such as peer-review journals makes progress possible. But now in the United States, long an avatar of freedom and progress, the government's war on terror threatens to subjugate that tradition in a new culture of secrecy.

Washington DC-As part of its continuing investigation into competition and intellectual property rights, the US Federal Trade Commission and the Antitrust Division of the Department of Justice recently kicked off a series of hearings.

t a January meeting in Geneva, the Global Fund to fight AIDS, Tuberculosis, and Malaria (GFATM)-set up last year by an alliance of private donors, nongovernmental organizations (NGOs), foundations, national governments, and intergovernmental organizations-elected its directors, announced its funding criteria, and approved its first call for funding proposals.

Athough the Bush administration's $2 trillion budget proposal for fiscal year 2003 reduces spending on domestic programs overall, initiatives falling under the bioterrorism-preparedness umbrella escaped the axe. The result is more funding for biomedical research conducted by the National Institutes of Health and for FDA efforts to spur development and approval of new medicines and vaccines.

Even though FDA officials and company executives maintain that Purdue Pharma hasn't violated any rules governing pharma advertising, critics who want to ban the sale of the painkiller OxyContin complain about the company's promotional excesses. At a hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee in February, patient advocates blamed soaring abuse of the medication on company sales and advertising activities.

The spread of counterfeit products around the world has alarmed companies and international agencies and prompted them to accelerate efforts to address the problem

Executives at Enron aren't the only ones feeling the heat. ImClone's CEO and COO-brothers Samuel and Harlan Waksal-recently got an ultimatum from Bristol-Myers Squibb: Step aside and let BMS take Erbitux (IMC 225) through the approval process, or it will terminate their agreement. The Waksals refused, and BMS backed down-for now.

Pharmaceutical companies doing business in Europe had better heed EU antitrust laws. It does not take a genius to devise a cartel.

During the 2000 US election, prescription costs-especially for seniors-was a hot issue that both parties offered to resolve. Intervening events have since distracted the federal government from domestic healthcare issues, leaving states to take the initiative in lowering drug expenditures. Two states' programs led the way, drawing legal challenges from the pharmaceutical industry. Recent opinions by US courts of appeals in those cases reached conflicting results; but viewed together, they provide guidance for the types of state plans that will be sustained. Meanwhile, other programs are making their way through state legislatures around the country.

Ireland-After its share price collapsed in the wake of the Enron scandal and growing concern about shady accounting practices, Elan said it would "vigorously defend" itself against allegations that it violated US federal securities laws.

From flacks and hacks to spin doctors and drug pushers, the cliches used to describe healthcare public relations professionals have fostered an image of PR that is, if not downright sleazy, at least suspect.

Last year's average turnover among general physician sales reps was 19 percent-up 2 percent from 2000-making retention the number one human resource issue for pharmaceutical companies today. Industry employers are discovering that despite all the resources

Product developers - working in everything from discovery to quality control - have become so proficient at generating information that they're drowning in data. At the same time, the race to bring innovative pharmaceuticals to market is intensifying.

Soon people will remember animated ad banners and the measurement of their click-through rates as merely the first generation of online marketing.

The integration and digitization of fragmented data is about to transform pharmaceutical sales and marketing strategies. And physicians are ready to adopt the new business model of an e-prescribing network

Every night at Merck facilities around the world, an automated computer clicks and whirls as it collects proteins and DNA sequences, in an inexorable process that has built a mountainous terabyte of data at four research centers. And that data will double every eight months.