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Pharmaceutical Representative, Apr 1, 2003 Nearly o­ne in five small employers (19%) offering health insurance modified health benefits during 2002, according to a new survey by the Washington-based Employee Benefit Research Institute, which found that the changes often led to higher employee costs.

When it comes to recruiting and enrolling individuals in clinical trials, the industry's challenge is similar to the o­ne that General Riggs cites in his call to modernize the US Army. For clinical research, the challenge is not just about using mass radio advertising or direct mail to recruit qualified study volunteers. It is to develop a system that integrates recruitment strategies with the screening and enrollment process, enabling pharma companies to: track trial patients from the first point of contact to the end of the study measure the recruitment strategies' effectiveness in reaching new consumers adjust recruitment strategies quickly predict the randomization period (the time it takes to select and assign volunteers to a clinical study) analyze the return o­n investment (ROI)

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As healthcare struggles to reinvent itself, a confluence of major societal forces has irrevocably changed both the business world and the healthcare landscape. Those forces include globalization; market deregulation and privatization of businesses; new conduits of information such as the internet, telecommunications, and media; increasingly complex and technologically sophisticated products; and an unprecedented erosion of trust in corporations and institutions. The changes have also had direct and profound impact o­n the pharma industry and o­n the vigor of larger healthcare business, resulting in new communications opportunities and challenges.

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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.

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Rising government pharmaceutical expenditures have attracted the attention of federal prosecutors, and the scrutiny is expected to expand. With Congress spending billions to fight terrorism, federal investigators are looking closely at healthcare for opportunities to trim outlays and collect big penalties. During the past 15 years, the government has recovered nearly $8 billion from violators of the False Claims Act, almost half of that from health-related cases. The record $875 million fine recently paid by TAP Pharmaceuticals is encouraging both investigators and company whistleblowers to jump o­n anything that smacks of fraud.

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In a British underground secret service lair, the resourceful Q reluctantly hands 007 a bottle of Cialis and asks him not to disappear for the weekend. In a South African jungle, Arnold Schwarzenegger chomps a cigar after decimating a series of small villages and announces to the camera: "I'll be back.I need to take my Lipitor." In the crowded halls of high schools in teen movies everywhere, the popular football player informs his pimply faced lab partner about Accutane. Of course, none of that really happened. Pretty Woman actress Julia Roberts never took Valtrex. No physician ever prescribed Xenical to Fat Albert. And in Leaving Las Vegas, the alcoholic character, Ben Sanderson, opted for suicide rather than Campral.

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More than half of all Americans (57%) have suffered chronic or recurrent pain in the past year, according to a nationwide survey conducted by Washington-based Research!America. The survey found that younger people (age 18 to 34) are o­nly slightly less likely than older Americans to be in pain, and the impact of pain is experienced by three out of every four people; 76% of those surveyed said they are either suffering from pain themselves or have a close family member or friend who suffers.

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Before Botox became a popular beauty treatment, Allergan was just a small ophthalmic business that made prescription eye therapies and contact lens care products. But during a decade of off-label use-mostly in Hollywood as a quick fix for frown lines-Botox's (botulinum toxin type A) sales grew and slowly transformed the company's focus and future. Last year, FDA approved the product for cosmetic purposes, opening the door to consumer advertising, and its sales jumped 39 percent from the first quarter 2002 to the first quarter 2003.

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CNN's new policy of full disclosure of celeb-rities' financial ties with pharma companies drew media attention from the New York Times and other outlets. Megan Mahoney, who works in CNN's public relations department, said that, in light of recent attention surrounding paid celebrity endorsements, the company became aware that some celebrities discussing health problems might be paid and changed its policy.


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Does FDA harm patients by rushing unsafe products to market or by slowing product development and approval? That debate came to the fore recently with the almost simultaneous release of competing studies. Public Citizen director Sidney Wolfe and Harvard Medical School researchers published a report in the Journal of the American Medical Association (JAMA) accusing FDA of approving too many unsafe new drugs. Reseachers had examined the number of new therapies approved between 1975 and 2000 that were subsequently withdrawn from the market or had black-box warnings added to their labels. The take-home message is that physicians should avoid prescribing any therapy that is less than seven years old if an alternative treatment is available and that FDA should be much more careful in approving new medicines.



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