| Critics say drug trials often a marketing tool By Alice Dembner, Globe Staff SOURCE: Boston Globe CHICAGO - Drug manufacturers spent $1.5 billion in 2000 to test medicines already approved by the Food and Drug Administration primarily so they could make new marketing claims to sell their products, industry specialists said this week. Critics say the trend inflates health care costs while undercutting the integrity of research. Spending on these "post-approval" drug studies tripled in the last half of the 1990s, growing faster than any other clinical drug research, according to CenterWatch, a Boston-based firm that presented the data at the national meeting of the Drug Information Association. CenterWatch, which monitors the pharmaceutical industry, said approximately 700,000 patients completed post-approval studies last year. "What used to be a scientific purpose - clarifying effectiveness and safety in a larger population - has turned into a commercial purpose," said conference speaker Nayan Nanavati, a vice president at Parexel, an international company based in Waltham that conducts studies for drug firms. "However, it must still be supported by a scientific need." These studies can yield important new information on safety and uses of drugs, such as a 2000 study that found the hypertension drug Ramipril could reduce the risk of heart attacks. But regulators and consumer advocates say the studies are helping increase health care costs, can put some patients at risk, and may taint the public's view of safety testing necessary to get new drugs on the market. "If studies are done primarily for marketing purposes, are they serving the interests of the public?" asked Dr. Greg Koski, director of the federal Office for Human Research Protections. "It could undermine the integrity of the scientific enterprise." Before medicines can be marketed, they must be extensively tested in people to ensure that they are safe and effective. Pre-market studies are closely regulated by the FDA and tend to involve fewer than 1,000 patients per study. When the FDA has further questions about a drug's safety, the agency requires more testing after approval. But the bulk of testing after FDA approval is being done so companies can differentiate their drugs from competitors' and generate more demand, the conference panelists said. The panelists, speaking in two separate sessions, mentioned studies of drugs for Alzheimer's disease, hypertension, arthritis, and heart disease as examples of marketing-driven research. Some studies are also used to hint at a new use for a drug - and encourage doctors to prescribe it for that purpose - without going through a lengthy FDA review, the speakers said. Nonetheless, the studies must have some valid scientific purpose or they may be halted by federal regulators. "It's a crowded market, so it's critical to position your drug," said Nanavati, adding that most drug companies will not acknowledge the major role marketing plays in their studies. In most post-approval studies, hundreds of doctors are paid to prescribe new medications to thousands of patients, who receive the drugs for free. While many of these patients might get the drug anyway outside the study, others may get a more expensive drug than their doctor would otherwise prescribe. The studies themselves typically cost between $10 million and $40 million, the speakers said. |
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