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Americans Confused About FDA and Drug Safety

Poll finds many mistrust the job the agency is doing

THURSDAY, Sept. 20 (HealthDay News) -- Although millions of Americans depend on prescription medicines for health, many are confused and distrustful of government's role in keeping those medicines safe, a new survey finds.

In fact, many of those polled said they didn't understand how the U.S. Food and Drug Administration approves drugs, and almost half judged the agency's performance as poor.

"The American people feel that health care is, after the war, the most important issue facing them and the 2008 presidential candidates," noted James Thurber, the director of the Center for Congressional and Presidential Studies at American University, which commissioned the survey. "Americans feel drug safety is related to health care, and they are concerned about it," he added.

Congress may be reacting to those concerns: On Wednesday, the U.S. House of Representatives passed the Food and Drug Administration Revitalization Act, which gives the FDA more money and power to ensure the safety of the nation's drug supply. The Senate is expected to pass the bill Thursday, and President George Bush is expected to sign it before Friday, when the FDA had been scheduled to begin laying off 2,000 employees.

The bill has the support of consumer advocates. "Congress is about to give the President legislation that should end the secrecy and foot-dragging when it comes to letting consumers know about unsafe medicines," Jim Guest, president of Consumers Union, publisher of Consumer Reports, said in a statement. "These reforms have been anxiously awaited by the millions of consumers who take a prescription drug every day and wonder if they know the truth about its side effects," he added.

In the meantime, however, Americans remain unsure about drug safety and the FDA's record so far. Some key findings from the new survey:

  • Most Americans (64 percent) believe that the U.S. health care system is "broken."
  • More than three-quarters believe a candidate's position on drug safety is "somewhat important" in choosing the next president.
  • A vast majority of Americans (88 percent) are confident that prescription drugs made in the United States are safe. In contrast, only 56 percent think that drugs made in Canada and Europe are safe, and only 14 percent think that drugs made in China and India are safe. Many of the drugs sold in the United States are made in China and India, Thurber noted.
  • Eighty-two percent of those polled said they trust the FDA when it comes to overseeing prescription drugs, 74 percent trust patient-advocate groups, 67 percent trust pharmaceutical companies, and 53 percent trust Congress.
  • A full 50 percent of Americans are skeptical of the ability of Congress to pass "common-sense" laws on how the FDA approves drugs, however. "Only 6 percent trust Congress to do the right thing," Thurber said.

But while the public trusts the FDA on the whole, they are divided about the agency's performance:

  • Of those surveyed, 53 percent said the FDA does an excellent or good job, while 47 percent rated its performance as fair or poor. Those aged 18-34 were more positive about the FDA, while seniors were more negative.
  • Few (8 percent) had either seen, read, or heard about the Food and Drug Administration Revitalization Act (FDARA).
  • People were equally divided on whether the FDA's review of new drugs should be paid for by the drug industry -- 47 percent were for the move, and 46 percent were against it.
  • Only 54 percent knew that the FDA approved all prescription drugs, while 37 percent thought that the FDA approved only some drugs.
  • Many people were confused about where the FDA gets its funding. Fifty-four percent said the government, 20 percent said drug companies, and 17 percent said both.
  • Nearly half of respondents (43 percent) believed that drug company profits were the biggest factor in drug costs, 28 percent thought drug prices were more linked to marketing costs, and only 25 percent cited the cost of research.

All of this shows that there's a lot of misinformation or confusion about what the FDA does, Thurber believes.

"In addition, there is a lot of mistrust in Congress about what it should or will do with respect with laws governing the FDA," he said. "There is also a lot of concern about the safety of drugs in the United States."

Educating the public would be a good first step, Thurber added. "The FDA needs to do a better job about being transparent and open about what they do and their findings," he said.

Cases like the 2004 withdrawal of the painkiller Vioxx (banned after being tied to heart risks) seriously undermined the FDA's credibility and made some people wary of using any prescription drugs, he said.

"When they see an incident like Vioxx -- they get really fearful. That's why many people think government is not doing its job," Thurber said.

The findings in the survey were based on calls to 800 adults. The survey was conducted by the Mellman Group and Public Opinion Strategies and ran from Sept. 4 to Sept. 6, 2007. The survey has a margin of error of plus or minus 3.46 percent.

One expert believes the survey didn't go far enough, however.

"Instead of focusing on whether safety is important, it would be much more interesting to ask the American people whether they would be willing to make real tradeoffs in the development and availability of innovative and potentially lifesaving therapies in order to improve our safety record," said Dr. A. Mark Fendrick, a professor of health management and policy at the University of Michigan.

"This is the real question that needs to be addressed, and it does not appear that most of the public opinion surveys are willing to go that far," he added.

This study demonstrates that when it comes to drug therapy, Americans are appropriately concerned with an increasing number of drug-related adverse events, Fendrick said.

"Yet, before we put in place a new level of regulation to ensure greater safety for prescription drugs, it is important to weigh the health gains from the use of these [drugs] against the documented risks before judgment can be made," Fendrick said. "As should be the case of all the things we do as doctors, both the risks and benefits of pharmaceuticals should be carefully evaluated."

More information

For more on drug safety, visit the U.S. Food and Drug Administration.

SOURCES: James Thurber, Ph.D., director, Center for Congressional and Presidential Studies, American University, Washington, D.C.; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, and professor, health management and policy, University of Michigan School of Public Health, Ann Arbor; Sept. 19, 2007, news release, Consumers Union; Sept. 20, 2007, Prescription Drug Safety: National Survey

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