DRUG ADVERTISING: Clinical Trials In Market Research

      The second of two Wall Street Journal articles today on spiraling pharmaceutical costs takes a look at a rising trend in clinical trial spending aimed specifically at identifying the marketable attributes of certain drugs. One of the main reasons new drugs are so expensive, say drugmakers, is "the high cost of clinical trials." Clinical trials already total some $7 billion per year -- 40% of the industry's total U.S. research budget -- and DataEdge LLC estimates that "the testing bill for each new drug submitted to the FDA is rising by about 12% a year." The Journal notes that new drugs typically undergo an average of 70 trials, compared with the usual 30 in the 1970s. Drugmakers say they are spending more on clinical trials "because they are tackling tougher diseases and performing more safety tests." But the Journal reports that many of the "biggest trials" are not on "difficult-to-treat diseases," but in "well-established therapeutical areas ... where enormous testing programs are needed to ferret out small advantages over existing drugs that can then be highlighted in marketing campaigns."

Put It In A Jingle
      The Journal reports that "fully one-quarter" of all patients in clinical trials are enrolled in "postmarketing" studies in which new products are measured against "myriad rivals in hopes of finding incremental differences that will allow them to land a better ad slogan, a broader treatment claim or a spot on the restricted list of products insurers will reimburse." Meanwhile, "marketing executives are joining research teams from the start, surveying doctors and consumers and tailoring trials to win optimal 'positioning' in the marketplace." For example, in a trial that could cost as much $200 million, Bristol-Myers is testing its blood-pressure drug omapatrilat against competing therapies -- Merck's Vasotec and Cozaar and Pfizer's Norvasc -- to see if it will work better than its competitors, especially among African Americans and elderly people. Eve Slater, Merck's senior vice president for clinical testing, acknowledged that postmarketing studies "are billowing out of control," but said competition among pharmaceuticals demands "you have to do it, too, or you are dead in the water." Sol Rajfer, Bristol-Myers' senior vice president of R&D, said the growth of clinical trials is not fueled solely by marketing concerns, but "is driven by science." He said, "'These trials help doctors use the drugs wisely,' and could result in important public-health benefits" (Langreth, 11/16).