Pharmaceutical Executive-05-01-2002

The National Institute of Health Care Management made headlines with its report on double-digit increases (17 percent) in retail spending on medicines in 2001. The total reached $155 billion last year, almost double the $80 billion spent in 1997, according to the study, "Another Year of Escalating Costs." PhRMA president Alan Holmer said the increase is a good thing, signifying that more people who need medicines for chronic conditions are being treated and thereby avoiding more expensive medical procedures.

African-American physicians regard direct-to-consumer advertising of prescription medicines as one way to educate minority patients about needed treatment and healthcare options, according to a survey conducted by the National Medical Association (NMA). Almost all of the 900 physicians answering the questionnaire reported that DTC advertising has prompted patients to ask questions, and one-third acknowledged that they feel additional pressure to justify their prescribing decisions. But almost half (48 percent) said that such promotion increased communications between physicians and patients.

A flood of counterfeit medications into the Nigerian market is causing great concern among the nation's regulatory authorities, according to a British Medical Journal report. Many fakes may contain a small amount of the active ingredient but not enough to make them therapeutically useful. Under-strength antibiotics represent a significant public health problem, as the inadvertent administration of them can lead to bacterial resistance.

Among the dozens of initiatives in Washington affecting the pharma industry, one common thread is the growing movement to control accelerating expenditures for prescription medicines.

Science deserves all the credit it gets, and more, for driving this industry. Still, no science succeeds without a certain application of what we broadly call art. Inside the scientific discipline, many arts apply-the art of experiment, the art of planning, and the art of free association among them.

Because of the European Union's country-by-country drug price controls, enterprising wholesalers often buy prescription drugs in nations that keep prices low and resell them in countries that allow higher prices. Sanofi-Synthelabo's Plavix costs $55 in France but is resold for $79 in England. That long-standing practice, known as parallel trade, costs the pharma industry an estimated $3 billion in lost profits each year.

As of 2000, there were approximately 7,500 clinical projects in the R&D pipeline worldwide, according to IMS Health. By 2003, analysts estimate the total number will grow to more than 10,000 clinical projects worldwide. CenterWatch reports that for each new drug application to FDA, pharma companies must conduct an average of 68 studies (Phases I-III) that need a total of 4,300 volunteers. With the expected increase in global R&D projects over the next year, the number of patients needed for enrollment is expected to grow by 15 percent annually.

The returns are in, and they are not pretty. Janus Funds' billion-dollar investment in WebMD in 2000 now has a net value of roughly ten cents on the dollar, and many observers see WebMD as a winner in their space-whatever that space is now.

The European Medicines Evaluation Agency (EMEA) has promised to get tough with pharma companies if they fail to follow its rules for reporting product side effects. It may resort to naming and shaming those that do not comply and could even prosecute offenders.

Kiln, a Lloyds of London underwriter, has come up with a novel way for pharma companies to mitigate the risk of patent challenges: insurance. Kiln created a policy for a big pharma company covering a number of patents and trademarks the company considers essential for its future profitability.

Clinical trials are complex, time consuming, and data intensive. Yet pharma remains one of the few industries that is still largely paper driven.

As the fanfare over the sequencing of the human genome fades, the spotlight turns to the "shovel and pans" companies offering the tools investors are betting on to make "gene to drug" a reality.

Products in Trouble

After three successive blows, Wall Street analysts say BMS, the fifth largest global pharma company, could be a takeover target. First came FDA's refusal to review the data for Erbitux (IMS 255), BMS and ImClone's joint cancer treatment candidate in which BMS has invested more than a billion dollars. Two months later, the company announced that next year's earnings might be only half that of this year. Disappointed stockholders unloaded in droves, driving the price down nearly 15 percent. And to top it off, the board of directors has put CEO Peter Dolan on notice: one more stumble and he's