April 2007
Consumer Reports survey finds strong backing for drug reforms
As Congress prepares to vote on the most significant prescription drug safety legislation in 45 years, a new Consumer Reports poll finds that the American public strongly backs a number of reforms. Safety issues rose to the top, with 9 of every 10 Americans supporting reforms that would require warning labels and follow-up studies on drugs with safety problems, and public disclosure of all clinical drug trials.
More than 60 percent of Americans also 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, president and 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,'' he said. "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. It has a sampling error margin of plus or minus 3 percentage points. Responses are representative of the general public. Among them:
Such studies are used to get a drug approved, and they generally use human subjects. The makers of Vioxx and Paxil had results of studies that indicated safety problems for years, but downplayed those results. Vioxx eventually was removed from the market after being linked to hazardous side effects and thousands of deaths.
In general, Americans support the government's taking whatever steps are 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.
Legislation introduced in both houses of Congress and expected to be put to a vote soon would give the FDA increased safety authority once a drug is on the market, and require that most clinical trial studies be made public. Consumers Union is working to strengthen that legislation to require the release to the public of all clinical trial data, as well as to raise the profile of drug safety and science in the FDA.
CONFLICT OF INTEREST IS A TOP CONCERN
The survey also 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 situation.
Congress is expected to soon reauthorize the Prescription Drug User Fee Act, which was first passed in 1992 to speed up drug approvals by having the industry help pay for the approval process. The original act has been extended twice and is scheduled to expire this fall unless Congress reauthorizes it. The new proposal calls for the industry to pay $393 million annually to the FDA, an increase of $87 million over the previous PDUFA agreement.
Consumers also were concerned about conflicts of interest on advisory boards that approve drugs for market. Six of 10 disapproved of allowing doctors and scientists with a conflicting financial interest to serve 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 have experienced an adverse reaction to a medication.
LIMITS ON PRESCRIPTION DRUG ADVERTISING
Americans are very aware of prescription drug advertising, with 9 of 10 Americans (91 percent) reporting they had seen a drug ad on television or in print, or heard one on the radio. More than a quarter of those (26 percent) said they had asked for a prescription for a specific medication that they learned about in an ad.
In 2006 pharmaceutical companies spent a record $5.5 billion advertising their prescription-drug brands, about 15 percent more than the previous year.
Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent "strongly agreeing." And 59 percent agreed that 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 that they help consumers take charge of their health care (54 percent agree, 14 percent strongly agree).
As Congress prepares to vote on the most significant prescription drug safety legislation in 45 years, a new Consumer Reports poll finds that the American public strongly backs a number of reforms. Safety issues rose to the top, with 9 of every 10 Americans supporting reforms that would require warning labels and follow-up studies on drugs with safety problems, and public disclosure of all clinical drug trials.
More than 60 percent of Americans also 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, president and 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,'' he said. "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. It has a sampling error margin of plus or minus 3 percentage points. Responses are representative of the general public. Among them:
- 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. Currently, the FDA 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. Currently, the FDA generally does not have the authority to require that a safety study be performed once
a drug is on the market.
- 84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited, with 59 percent "strongly
agreeing" to such limits.
- 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 they generally use human subjects. The makers of Vioxx and Paxil had results of studies that indicated safety problems for years, but downplayed those results. Vioxx eventually was removed from the market after being linked to hazardous side effects and thousands of deaths.
In general, Americans support the government's taking whatever steps are 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.
Legislation introduced in both houses of Congress and expected to be put to a vote soon would give the FDA increased safety authority once a drug is on the market, and require that most clinical trial studies be made public. Consumers Union is working to strengthen that legislation to require the release to the public of all clinical trial data, as well as to raise the profile of drug safety and science in the FDA.
CONFLICT OF INTEREST IS A TOP CONCERN
The survey also 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 situation.
Congress is expected to soon reauthorize the Prescription Drug User Fee Act, which was first passed in 1992 to speed up drug approvals by having the industry help pay for the approval process. The original act has been extended twice and is scheduled to expire this fall unless Congress reauthorizes it. The new proposal calls for the industry to pay $393 million annually to the FDA, an increase of $87 million over the previous PDUFA agreement.
Consumers also were concerned about conflicts of interest on advisory boards that approve drugs for market. Six of 10 disapproved of allowing doctors and scientists with a conflicting financial interest to serve 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 have experienced an adverse reaction to a medication.
LIMITS ON PRESCRIPTION DRUG ADVERTISING
Americans are very aware of prescription drug advertising, with 9 of 10 Americans (91 percent) reporting they had seen a drug ad on television or in print, or heard one on the radio. More than a quarter of those (26 percent) said they had asked for a prescription for a specific medication that they learned about in an ad.
In 2006 pharmaceutical companies spent a record $5.5 billion advertising their prescription-drug brands, about 15 percent more than the previous year.
Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent "strongly agreeing." And 59 percent agreed that 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 that they help consumers take charge of their health care (54 percent agree, 14 percent strongly agree).
