What are people saying about the FDA?

Here are quotes about the FDA's failures in recent years:

• Dr. Jerry Avorn, a Harvard Medical School expert who wrote a book on the drug industry, says recent revelations about the FDA suggest "a culture of denial"
  
• "The system itself is completely broken," says Dr. David Graham, a senior safety
  
• "The industry has now captured the agency that is supposed to be regulating it," claims Dr. Marcia Angell, a former editor of the New England Journal of Medicine who wrote a recent book on the drug industry.
  
• The FDA's Galson says it is legitimate to ask if more or better testing is needed. "Everybody knows that the system we have now is not adequate to pick up all adverse events that will occur once a drug gets out into the population. The question is, are we willing to pay for more trials?"
  
• "If a plane crashes off the coast of New York, we don't leave the investigation to the controllers that were controlling the plane and the airline that was flying it," says Dr. Alastair Wood, a Vanderbilt University pharmacologist and FDA drug safety adviser.
  
• A "picture is emerging of an agency that can't see the forest for the trees," Sen. Chuck Grassley, R-Iowa said. "Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work 'scientific rumor.'"
  
• I think the recommendation about high dose rofecoxib is unnecessary and particularly problematic since FDA funded this study and David?s travel to France to present it,? Anne E. Trontell, deputy director of the FDA?s Office of Drug Safety, wrote in an Aug. 12 e-mail.
  
• "We also do not understand how FDA personnel can say that Celebrex 'may be safer. It seems highly unprofessional for the FDA, if they did, to enter into the competition between these two popular drugs for arthritis," wrote Barbara K. Hecht, Ph.D. and Frederick Hecht, M.D., Medical Editors, MedicineNet.com
  
• "No drug is fully safe," said Crystal Rice, an FDA spokeswoman.
  
• There is no provision for systematically assessing and reviewing the safety of the many, many medications that are out there," said, Dr. Wayne A. Ray, a Vanderbilt professor of preventive medicine, "And the patients are the ones who are going to suffer."
  
• "If you're the FDA, you'll say, 'OK, all bets are off. We're going to make you do studies lasting 18 months,'" said Dr. Sidney Wolfe, director of Public Citizen.
  
• In another class of drugs, another FDA reviewer, Dr. Andrew Mosholder, "had warned that antidepressants were linked to suicidal behavior in pediatric patients, but supervisors initially kept him from making those views public."
  
• "In 1998, Dr. Doug Watson, a Merck scientist, presented an analysis of serious heart problems with Vioxx compared to patients enrolled in studies of other Merck drugs. This analysis concluded that men taking Vioxx had a 28 percent greater risk (not statistically significant), but in women, the risk was more than double (216 percent, statistically significant) compared to people not taking any drug in other Merck studies. To the best of my knowledge, these data were never made public." according to the testimony of Gurkirpal Singh, from the Stanford University School of Medicine, and Bruce Psaty, co-director of the Cardiovascular Health Research Unit at the University of Washington