Pharmaceutical Executive-12-01-2001

Investor expectations, fueled by promises of genetic breakthroughs, are at an all-time high. Markets segmented by genetics-based diagnoses and rising demand for individualized care will soon make their mark on the industry's dominant blockbuster strategy. Rather than losing sleep over that, pharmaceutical executives can secure competitive advantage by capitalizing on the combination of consumers' rising power, increased access to information, and rejection of one-size-fits-all treatment regimens.

Washington, DC-With no signs that FDA plans to significantly limit direct-to-consumer advertising of prescription medicines, state governments across the country are proposing their own curbs. During the past year, legislators considered some 60 bills or resolutions concerning pharma marketing or advertising, and efforts are likely to increase as state policy makers link DTC advertising to rising drug expenditures.

No one can pinpoint the precise instant it happened, but the dull cloud of our universe suddenly cleared. About a half-billion years had gone by since the Big Bang, finally giving the condensing proto-stars and quasars enough time to sweep a veil of dust from the young cosmos. Their light then penetrated the darkness and, along with that of countless other spawning suns, has traveled the skies ever since.

Co-promotion agreements and a wide variety of strategic alliances are redefining the pharmaceutical industry. Yet interviews with 28 executives from 12 companies that have chosen or are seeking a pharma partner to market a late-stage compound confirm a disturbing fact: Despite much executive-suite talk about becoming the "partner of choice," few companies have devoted the resources needed to build alliance infrastructures that will support the entire portfolio of co-promotion deals, licensing agreements, R&D collaborations, and other relationships that are quietly reshaping their organizations.

Geneva, Switzerland-A Medecins sans Frontieres (Doctors without Borders) report claiming there is virtually no research into diseases that predominantly affect the poor is distorted and politically motivated, says Dr. Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). He claims that medicines do exist to treat most of the more dangerous diseases affecting poor people, but in many cases they do not reach patients for reasons that are beyond control of the pharmaceutical industry.

Washington, DC-The run on Cipro following October's anthrax scare was a bonanza for pharmacy websites, but it stirred the wrath of both FDA and the medical establishment. In response to escalating ciprofloxacin promotion over the internet, FDA sent cyber letters to 11 websites for offering US consumers products that may not be approved for sale in the United States, warning that US Customs might detain shipments. The agency also took more stringent action against five previously warned foreign vendors.

Johannesburg, South Africa-GlaxoSmithKline announced in October that it had licensed Aspen Pharmacare to manufacture three AIDS products: Retrovir-AZT (zidovudine), Epivir-3TC (lamivudine), and Combivir (zidovudine/lamivudine). The products can be distributed only to the public, including the government, non-governmental organizations (NGOs), and charitable bodies accredited by the World Health Organization (WHO).

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.

Calls for change reflect that generic products are a therapeutic mainstay and that patients and providers want earlier access to inexpensive medicines.