Fw: [NVIC] FDA Scientists Have Drug Concerns

[Guest guest]

[NVIC] FDA Scientists Have Drug Concerns

> E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

> Vienna, Virginia http://www.nvic.org

>

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> #9119

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> " Protecting the health and informed consent rights of children since

1982. "

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============================================================================

==============

> http://www.washingtonpost.com/ac2/wp-dyn/A3135-2004Dec15?language=printer

> washingtonpost.com

>

> Many FDA Scientists Had Drug Concerns, 2002 Survey Shows

>

> By Marc Kaufman

> Washington Post Staff Writer

> Thursday, December 16, 2004; Page A01

>

> Almost one-fifth of the Food and Drug Administration scientists surveyed

> two years ago as part of an official review said they had been pressured

> to recommend approval of a new drug despite reservations about its

> safety, effectiveness or quality.

>

> The survey of almost 400 scientists also found that a majority had

> significant doubts about the adequacy of federal programs to monitor

> prescription drugs once they are on the market, and that more than a

> third were not particularly confident of the agency's ability to assess

> the safety of a drug.

>

> The results of the survey, conducted by the Department of Health and

> Human Services' inspector general, appear to support some portions of

> the controversial Senate testimony last month by FDA safety officer

> J. Graham. The 20-year agency veteran told senators that the FDA

> was unable to keep some unsafe drugs off the market, and that scientists

> who dissented about drug safety and effectiveness were sometimes

> pressured and intimidated.

>

> Graham's testimony, at a hearing into the sudden withdrawal from the

> market of the arthritis drug Vioxx, put a spotlight on the FDA's safety

> and management record. Top FDA officials later criticized Graham's

> testimony as inaccurate and unscientific, but the survey results

> indicate that some other agency scientists share similar views.

>

> " I think this provides evidence that among the reviewing scientists at

> FDA, their experiences mirror the testimony I gave before Congress, "

> Graham said yesterday. " It also shows the unfortunate experience of many

> mirrors what happened to me when I tried to bring safety issues to my

> managers and the American public. "

>

> The complete survey will be made public today by the Union of Concerned

> Scientists and Public Employees for Environmental Responsibility, two

> public interest groups that received the documents through the Freedom

> of Information Act process. The Washington Post obtained a copy yesterday.

>

> When the inspector general's report on the effectiveness of the FDA's

> drug review process was released in March 2003, administration officials

> focused on the conclusion that FDA reviewers and drug sponsors " have

> confidence in the decisions FDA makes. " The report also highlighted the

> agency's effectiveness in reducing the time it takes to review a new

> drug approval.

>

> The survey was conducted as part of the inspector general's inquiry, but

> only parts of it were included in the report. The dissenting voices of

> some FDA scientists were not generally represented in the study, by

> former inspector general Janet Rehnquist.

>

> In a statement, the FDA said yesterday that the study showed that

> overall, " FDA medical reviewers found their work at the agency to be

> rewarding -- a result consistent with many other quality of workplace

> surveys conducted throughout the government which have shown that FDA

> workers are proud of the agency and the service it provides to the

> American people. "

>

> While the final inspector general's report emphasizes the agency's

> successes, the survey, conducted at the FDA's request, found underlying

> concern and discord. For instance, 36 percent of scientists said they

> were only somewhat confident, or not confident at all, in the FDA's

> decisions regarding drug safety. When it came to drug effectiveness, 22

> percent of scientists said they were only somewhat confident, or not

> confident at all, in the agency's decisions.

>

> As described in the report, drug manufacturers reported significantly

> greater confidence in both categories.

>

> Some of the most dramatic Senate testimony that Graham delivered

> involved what he described as efforts by FDA supervisors to silence him

> and pressure him to limit his criticism of the safety of some drugs. In

> the survey, 63 of 360 respondents -- 18 percent -- said they had been

> " pressured to approve or recommend approval for a [new drug application]

> despite reservations about the safety, efficacy, or quality of the drug. "

>

> Similarly, 21 percent of survey respondents said the work environment at

> the FDA's Center for Drug Evaluation and Research either allowed little

> dissent or stifled scientific dissent entirely.

>

> K. Galson, acting director of the center, has acknowledged some

> problems regarding safety reviews and the handling of internal

> scientific dissent at his agency but has described them as limited.

> Nonetheless, the agency last month asked the congressionally chartered

> Institute of Medicine to look into the FDA's system for assessing drug

> safety.

>

> The FDA drug reviewers were also highly skeptical of the agency's

> ability to monitor the safety of prescription drugs once they are on the

> market. In all, 6 percent said they were " completely confident, " 28

> percent said they were " mostly confident, " 47 percent said they were

> " somewhat confident " and 19 percent said they were " not confident at all. "

>

> Rehnquist's report found that some FDA reviewers believed that the

> speeded-up process for reviewing drugs required by Congress was causing

> morale problems among overworked scientists. More than half of

> respondents said they did not think there was sufficient time to conduct

> an in-depth, science-based review in the six months required for drugs

> given " priority " status.

>

> Graham, who participated in the inspector general survey, said he had

> never seen the complete survey results before. The findings are

> consistent with a 2001 study conducted by Public Citizen's Health

> Research Group.

>

>

>

> =============================================

> News@... is a free service of the National Vaccine Information

> Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed

> consent rights http://www.nvic.org

>

> Become a member and support NVIC's work

https://www.909shot.com/Making%20Cash%20Donations.htm

>

> To sign up for a free e-mail subscription

http://www.nvic.org/emaillist.htm

>

>

[Guest guest]

[NVIC] FDA Scientists Have Drug Concerns

> E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

> Vienna, Virginia http://www.nvic.org

>

> * * * * * * * * * * * * * * * * * * * * * * *

> UNITED WAY/COMBINED FEDERAL CAMPAIGN

> #9119

> * * * * * * * * * * * * * * * * * * * * * * *

>

> " Protecting the health and informed consent rights of children since

1982. "

>

>

============================================================================

==============

> http://www.washingtonpost.com/ac2/wp-dyn/A3135-2004Dec15?language=printer

> washingtonpost.com

>

> Many FDA Scientists Had Drug Concerns, 2002 Survey Shows

>

> By Marc Kaufman

> Washington Post Staff Writer

> Thursday, December 16, 2004; Page A01

>

> Almost one-fifth of the Food and Drug Administration scientists surveyed

> two years ago as part of an official review said they had been pressured

> to recommend approval of a new drug despite reservations about its

> safety, effectiveness or quality.

>

> The survey of almost 400 scientists also found that a majority had

> significant doubts about the adequacy of federal programs to monitor

> prescription drugs once they are on the market, and that more than a

> third were not particularly confident of the agency's ability to assess

> the safety of a drug.

>

> The results of the survey, conducted by the Department of Health and

> Human Services' inspector general, appear to support some portions of

> the controversial Senate testimony last month by FDA safety officer

> J. Graham. The 20-year agency veteran told senators that the FDA

> was unable to keep some unsafe drugs off the market, and that scientists

> who dissented about drug safety and effectiveness were sometimes

> pressured and intimidated.

>

> Graham's testimony, at a hearing into the sudden withdrawal from the

> market of the arthritis drug Vioxx, put a spotlight on the FDA's safety

> and management record. Top FDA officials later criticized Graham's

> testimony as inaccurate and unscientific, but the survey results

> indicate that some other agency scientists share similar views.

>

> " I think this provides evidence that among the reviewing scientists at

> FDA, their experiences mirror the testimony I gave before Congress, "

> Graham said yesterday. " It also shows the unfortunate experience of many

> mirrors what happened to me when I tried to bring safety issues to my

> managers and the American public. "

>

> The complete survey will be made public today by the Union of Concerned

> Scientists and Public Employees for Environmental Responsibility, two

> public interest groups that received the documents through the Freedom

> of Information Act process. The Washington Post obtained a copy yesterday.

>

> When the inspector general's report on the effectiveness of the FDA's

> drug review process was released in March 2003, administration officials

> focused on the conclusion that FDA reviewers and drug sponsors " have

> confidence in the decisions FDA makes. " The report also highlighted the

> agency's effectiveness in reducing the time it takes to review a new

> drug approval.

>

> The survey was conducted as part of the inspector general's inquiry, but

> only parts of it were included in the report. The dissenting voices of

> some FDA scientists were not generally represented in the study, by

> former inspector general Janet Rehnquist.

>

> In a statement, the FDA said yesterday that the study showed that

> overall, " FDA medical reviewers found their work at the agency to be

> rewarding -- a result consistent with many other quality of workplace

> surveys conducted throughout the government which have shown that FDA

> workers are proud of the agency and the service it provides to the

> American people. "

>

> While the final inspector general's report emphasizes the agency's

> successes, the survey, conducted at the FDA's request, found underlying

> concern and discord. For instance, 36 percent of scientists said they

> were only somewhat confident, or not confident at all, in the FDA's

> decisions regarding drug safety. When it came to drug effectiveness, 22

> percent of scientists said they were only somewhat confident, or not

> confident at all, in the agency's decisions.

>

> As described in the report, drug manufacturers reported significantly

> greater confidence in both categories.

>

> Some of the most dramatic Senate testimony that Graham delivered

> involved what he described as efforts by FDA supervisors to silence him

> and pressure him to limit his criticism of the safety of some drugs. In

> the survey, 63 of 360 respondents -- 18 percent -- said they had been

> " pressured to approve or recommend approval for a [new drug application]

> despite reservations about the safety, efficacy, or quality of the drug. "

>

> Similarly, 21 percent of survey respondents said the work environment at

> the FDA's Center for Drug Evaluation and Research either allowed little

> dissent or stifled scientific dissent entirely.

>

> K. Galson, acting director of the center, has acknowledged some

> problems regarding safety reviews and the handling of internal

> scientific dissent at his agency but has described them as limited.

> Nonetheless, the agency last month asked the congressionally chartered

> Institute of Medicine to look into the FDA's system for assessing drug

> safety.

>

> The FDA drug reviewers were also highly skeptical of the agency's

> ability to monitor the safety of prescription drugs once they are on the

> market. In all, 6 percent said they were " completely confident, " 28

> percent said they were " mostly confident, " 47 percent said they were

> " somewhat confident " and 19 percent said they were " not confident at all. "

>

> Rehnquist's report found that some FDA reviewers believed that the

> speeded-up process for reviewing drugs required by Congress was causing

> morale problems among overworked scientists. More than half of

> respondents said they did not think there was sufficient time to conduct

> an in-depth, science-based review in the six months required for drugs

> given " priority " status.

>

> Graham, who participated in the inspector general survey, said he had

> never seen the complete survey results before. The findings are

> consistent with a 2001 study conducted by Public Citizen's Health

> Research Group.

>

>

>

> =============================================

> News@... is a free service of the National Vaccine Information

> Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed

> consent rights http://www.nvic.org

>

> Become a member and support NVIC's work

https://www.909shot.com/Making%20Cash%20Donations.htm

>

> To sign up for a free e-mail subscription

http://www.nvic.org/emaillist.htm

>

>