Survey: FDA scientists question safety
By Julie Schmit, USA TODAY
And 18% of the almost 400 respondents said they had been pressured to approve or recommend a drug despite reservations about its safety, effectiveness or quality.
The survey, conducted by the Department of Health and Human Services (HHS) Office of Inspector General, was partially released last year. An advocacy group released the full report, acquired via the Freedom of Information Act.
The survey's details come amid rising criticism that the FDA puts too much emphasis on getting drugs to market and too little on protecting consumers from unsafe or ineffective drugs. Sen. Chuck Grassley, R-Iowa, told a Senate hearing last month he feared "that the FDA has a relationship with drug companies that is too cozy."
The survey results also lend credence to surprising congressional testimony last month by FDA scientist David Graham. The associate director of science and medicine in the FDA's drug safety office said the agency didn't adequately weigh safety concerns of drugs on the market and was incapable of preventing another Vioxx-type incident. The painkiller was pulled from the market Sept. 30 by maker Merck after a study tied it to increased risk of heart attack and stroke with long-term use.
The survey also found that:
•31% of the scientists were only "somewhat confident" and 5% were "not at all confident" that final decisions on new drugs adequately assessed the drug's safety; 52% were mostly confident; and 13% were completely confident.
•59% of them said the six months allotted to review some drugs wasn't enough time.
In a statement Thursday, the FDA said the study confirmed that, "overall," FDA medical reviewers believe their decisions appropriately assess drug safety and effectiveness and that debate is open and in-depth.
Still, the survey results "should cause a great deal of concern," says Arthur Levin of the Center for Medical Consumers, a New York-based patient advocacy group. But he says all fault doesn't lie with the FDA. Congress authorized it to collect fees from drugmakers to speed new drug approvals, blurring the line between those checking on drugs and those making them.
Grassley, a frequent FDA critic, said the survey helps "make an even stronger case" that a shake-up is needed at the FDA. That some scientists felt pressured, a survey statistic reported last year by consumer group Public Citizen, is noteworthy, says Jerry Avorn, author of Powerful Medicines and associate professor of medicine at Harvard Medical School. "Nearly one in five is a bad pattern," he says.
In contrast, HHS' report last year concluded that FDA scientists had "confidence" in FDA decisions. While noting that workload pressures may be harming the process, it said scientists did not believe they were ignoring key information or data in order to meet time goals. "We have no evidence of a public health concern nor did we seek to obtain such evidence," the report said.
Public Employees for Environmental Responsibility secured the survey and released it with the Union of Concerned Scientists.
Contributing: Donna Leinwand
2 comments:
Safety is a relative thing. If you are ailing would you rather the drug be manufactured with safety information made available to you and your doctor or would you rather wait until the FDA gathers data that proves without doubt that the drug is always safe? It seems to me that I'd rather have a choice. The FDA could be a great clearinghouse for interpretation of the latest clinical data, but I don't believe for a minute they can actually save us from carelessness in design or manufacture. No more than police can prevent all crime. I think stricter application of existing laws would only further shackle innovation and reduce choice for those who earnestly need help. Safety is a boogie man who can never be entirely satisfied. It's good to hear about risks, but what is safe for me ought be a very relative personal choice.
"If you are ailing would you rather the drug be manufactured with safety information made available to you and your doctor or would you rather wait until the FDA gathers data that proves without doubt that the drug is always safe?" --- Anonymous
I'll take safe without a doubt EVERY TIME over a drug rushed onto the market because the manufacturer wants to make a quick buck instead of relying on proven and ETHICAL research. Do you know WHY we have a FDA in the first place? Because of unethical marketers selling snake oil products and drugs that killed people.
"Safety is a boogie man who can never be entirely satisfied. It's good to hear about risks, but what is safe for me ought be a very relative personal choice." ---Anonymous
The logic of your argument would mandate that we get rid of stop signs at crossings. Why? Because it should be "a very relative personal choice" every time that you or anyone else reaches a crossing. According to you having laws to give structure and caution to a dangerous roadway is an impediment on your "personal choice" despite the evidence that restricted driving (as in this case mandating one LOOK before crossing another roadway) means less accidents and DEATHS.
And what's with being anonymous? Anyone that believes in personal freedom and responsibility like you do shouldn't hide behind a false front. Step into the light like a real American, not like someone afraid of the dark. My name and picture is on this blog. I've got nothing to hide. I promise I won't send agents to throw you into jail without lawyers the way the Bush administration does or have FBI agents knock on the door to intimidate you for posting views in opposition to Bush.
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