22 Practice Trends C ARDIOLOGY N EWS • October 2006 FDA Is Losing Credibility With Public, Own Staff

BY JOEL B. FINKELSTEIN everything we see and hear of scientific bers who have financial ties to industry. Contributing Writer value,” he said at a panel discussion on con- The advice the FDA receives from advi- Changes to the flict of interest on government science sory committees must span the breadth of — Members of the sci- panels sponsored by the Center for Science both clinical research and clinical practice, Advisory Process entific community have raised a red flag in the Public Interest. CSPI is a nonprofit he said. “That’s the kind of advice that you over increasing influence of money and consumer organization focused on food, can only get from people who are heavily he FDA recently announced sev- politics on what are supposed to be the in- nutrition, and health issues. engaged in clinical trials.” Teral steps it will take to codify dependent and unbiased internal workings Dr. Nissen criticized the agency’s top Dr. Gottlieb also announced FDA plans the processes for bringing in expert of the Food and Drug Administration and leaders for “whining incessantly” to Con- to revamp the advisory committee guide- voices and managing the agency’s other federal agencies. gress about the burden of regulation rather lines, including updated rules that deter- advisory committees. In a recent confidential survey of staff sci- than asking for more authority. “While the mine whether members need to be re- “There are places where we can entists in the FDA’s Center for Drug Eval- American people worry about the safety of cused due to a potential conflict of bring more consistency potentially uation and Research, 19% reported being drugs, the top FDA leadership tells us we interest. However, it is unclear how those to our processes. There are places pressured to push through a drug despite need fast drug approval,” he said. changes will relieve the concern, both in- where we can bring more trans- their reservations and 66% said that they Dr. Nissen said the appointments of side and outside the agency, that these pan- parency to the work we do. We were less than wholly confident that the Lester Crawford, D.V.M., Ph.D., and Dr. els are being manipulated. know that and we feel that doing so FDA adequately monitors the safety of as acting FDA “I’ve observed that [FDA] management is important to inspiring confidence drugs after they reach the market. commissioner and Dr. as and [drug and device manufacturing] com- in the process,” said Dr. Gottlieb. Across the agency, 50% of respondents FDA deputy commissioner for policy also panies have found ways to manipulate this Those changes are to include: said they did not believe that the FDA was have raised some troubling questions process in favor of approval. These meth- Ǡ Revamped guidance identifying headed in the right direction, according to about conflict of interest with the agency, ods are very subtle and would not easily be more clearly the conditions under the survey by the Union of Concerned Sci- he said. (Dr. Crawford eventually gained recognized,” recounted one respondent to which conflict-of-interest waivers are entists and Public Employees for Envi- Senate confirmation to his position, but re- the survey by the Union of Concerned Sci- granted. ronmental Responsibility. signed shortly thereafter.) entists. The anonymous respondent went Ǡ New guidance specifying when In the words of one staff scientist: “The “In his role as director of the National on to describe these techniques. those waivers will be disclosed to the FDA is presently being stacked at every Cancer Institute, [acting commissioner Within the FDA, scheduling conflicts public and what information will be management level, including the lowest von Eschenbach] must seek FDA approval can be used to exclude a committee mem- made available. levels, based on those who will support the for human testing or approval of new ber who is expected to oppose a drug’s ap- Ǡ New guidance specifying when big companies’ agenda, and the implica- cancer drugs, an obvious conflict of in- proval, and managers have been known to briefing materials used by advisory tions for safety and efficacy will be felt terest. Even worse, the administration has massage the presentations to the com- committees will be made available long into the future.” appointed Scott Gottlieb as deputy com- mittee to soften damaging findings. Drug to the public. Such influences have led to a “crisis in missioner, who came to this job with no companies have also learned that by hir- Ǡ Broader dissemination of advisory public confidence,” according to Dr. regulatory experience, directly from Wall ing experts as consultants, they can deny committee schedules through mail- Steven Nissen, who until last year chaired Street where he served as a biotech analyst FDA access to them, and that by hiring ings to public groups and electronic the FDA’s Cardiovascular and Renal Drugs and stock promoter,” Dr. Nissen said. committee members themselves, they can notifications through FDA listservs Advisory Committee. Also speaking as part of the panel dis- force them to be excluded from voting on and the Web site. “We have to work a lot harder now ...to cussion, Dr. Gottlieb refused to address a company’s drug. Ǡ A streamlined approach to the ap- keep the politicians out of the science as those observations, but defended FDA “We get the data that is presented to us pointment of members to drug-re- much as possible and to keep the com- policy that allows the agency leeway in and ... you can tell where the agency lated advisory committees. mercialization of science from coloring impaneling advisory committee mem- wants you to go,” said Dr. Nissen. ■ CLASSIFIEDS Also Available at www.ecardiologynews.com

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