Monday, April 16, 2007
(Washington, D.C.) – As Congress prepares to vote on the most significant prescription drug safety legislation in 45 years, a new Consumer Reports poll released Monday finds that the American public strongly backs a host of key safety reforms. Nine out of 10 agree that all clinical drug trial results should be made public, and that the government should have the power to require warning labels and follow-up studies on drugs with safety problems.
In general, the survey found consumers support the government taking whatever steps necessary to ensure the safety of prescription drugs – 84 percent agree that the government should “have the authority to take any action necessary” to ensure drug safety, with 50 percent strongly agreeing.
Also, more than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect consumers from harmful prescription drugs.
“The message we’re hearing from consumers couldn’t be clearer – they want strong laws to ensure our prescription drugs are as safe and effective as possible,” said Jim Guest, CEO of Consumers Union, publisher of Consumer Reports.
“Right now drug companies can game the system by touting the positive results from their drug studies, while downplaying information about harmful side effects,” Guest added. “Americans are fed up with being kept in the dark about critical health and safety information, and they overwhelmingly want change.”
The telephone survey of 1,026 randomly selected adults, conducted March 15-18 by the Consumer Reports National Research Center, asked about reforms that would strengthen the nation’s drug safety system. The margin of error is +/- 3.1 percent. Among the responses:
• 96 percent agree that the government should have the power to require warning labels if safety problems are identified – with 80 percent of those “strongly agreeing” to that authority. Right now, the Food and Drug Administration must negotiate safety warning labels with a drug maker.
• 93 percent agree that the FDA should have the power to order follow-up safety studies, with 65 percent “strongly agreeing” to that authority. Today, the FDA generally does not have the authority to require safety studies be performed once a drug is on the market.
• 92 percent of Americans agree that pharmaceutical companies should make public the results of all of their clinical trial studies, which reveal a drug’s effectiveness as well as possible hazardous side effects. Of those, 68 percent “strongly agreed” that drug studies should be made public.
Such studies are used to get a drug approved and generally are conducted on human subjects. The makers of Vioxx and Paxil had studies that indicated safety problems for years, but did not release those results to the public. Vioxx eventually was removed from the market after being linked to increased risk of heart attack and stroke; antidepressants in the class of Paxil now carry black-box warnings about increased suicide risk in adolescents and adults under 25.
• 84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited; with 59 percent “strongly agreeing” to such limits.
“Consumers expect Congress to take their concerns about drug safety seriously, and deliver legislation that will prevent future Vioxx-type disasters,” said Bill Vaughan, Consumers Union senior policy analyst.
“Failure to act this year on the strongest possible bill, when more than 80 percent of Americans agree that Congress should do whatever is necessary to ensure drug safety, would equate to gross legislative malpractice,” Vaughan added.
The Senate Health Committee is expected to vote Wednesday on a bill that includes important drug safety measures, as well as reauthorizing pharmaceutical industry user fees to support the FDA drug-approval and safety process (S. 1082). The last significant drug safety legislation in 1962 required manufacturers to prove their drugs had some positive effect, but failed to give the FDA power to quickly protect the public when safety questions were raised.
Consumers Union and other patient and safety organizations are working to further strengthen the drug safety legislation to require the public release of all clinical trial data, make safety disputes open to public scrutiny, and raise the profile of drug safety and science in the FDA.
Conflict-of-interests between Pharma and FDA also a top concern
The survey found that 84 percent of consumers agree that drug companies have too much influence over the government officials who regulate them. More than two-thirds (67 percent) are concerned that much of the FDA’s funding comes from the pharmaceutical industry, with more than half – 54 percent – “very concerned” about that funding situation.
Congress is expected this summer to reauthorize the Prescription Drug User Fee Act, first passed in 1992 to speed up drug approvals by having the industry help fund the FDA approval process. The original act has been extended twice and is slated to expire this fall unless Congress reauthorizes it. The FDA-industry proposal calls for industry to pay $393 million annually to the FDA, an increase of $87 million over the previous PDUFA agreement. S. 1082 adds additional user fees for safety.
Consumers also were concerned about conflicts of interest on advisory boards that approve drugs for market. Six in 10 disapproved of allowing doctors and scientists with a conflicting financial interest to participate on advisory boards.
More than half of consumers say they currently take a prescription drug, which translates to 124 million adults. A significant number – 40 percent – say they had experienced an adverse reaction to a medication.
“Four out of 10 Americans say they’ve had a bad reaction to a prescription drug, yet the FDA only receives about half a million adverse-event reports a year,” Vaughan said. “Clearly, the FDA needs to do a better job fielding consumers’ experiences with side effects.”
Prescription drug advertising influences prescribing; should be limited
Americans are very aware of prescription drug advertising, with nine out of 10 Americans (91 percent) reporting they had seen a drug ad on television or in print, or heard one on radio. More than a quarter of those (26 percent) said they asked for a specific medication they learned about in an ad.
Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent “strongly agreeing.” And 59 percent agreed the government should restrict advertising by pharmaceutical companies, with 26 percent strongly agreeing to such restrictions.
Yet some consumers find drug ads useful in talking to their doctor (63 percent agree, 24 percent strongly agree) and others agreed they help consumers take charge of their healthcare (54 percent agree, 14 percent strongly agree).
“Consumers are very concerned that advertising drives up the prescription drug use and health-care costs, and they’d like to see restrictions on those ads,” Vaughan said.
Contact: Susan Herold, Bill Vaughan (202) 462-6262