Congress to FDA: Ban Antidepressants to Protect America's Children

[Guest guest]

atracyphd2

Fri, 15 Oct 2004 08:46:41 EDT

Subject:[drugawareness] Congress to FDA: " Ban Antidepressants to

Protect America's Children "

 

 

 

From today's issue of the American Psychiatric Association's

publication, Psychiatry News, in an article titled, " Congress Hammers

FDA Over Handling of SSRIs " we read:

 

" Unsatisfied with answers and explanations from [FDA] agency officials

during the second hearing, at least two committee members, Rep. Diana

DeGette (D-Colo.) and Rep. Bart Stupak (D-Mich.), threatened to

introduce legislation banning the prescribing of antidepressants to

anyone under age 18 " if the FDA didn't act forcefully and swiftly to

protect America's children. "

 

Comments Vera Sharav of www.ahrp.org :

 

" How intreresting that this report in Psych Times, an APA publication,

more accurately reflects the two Cong hearings than did any reports in

the major ‘ independent’ press!Â

 

It is also disconcerting that the press didn’t grasp the

significance of the ‘ missing’ memos:  FDA officials like

Knudsen, have ‘off channel’ discussions with drug manufacturers

that leave no trace in FDA’s files…. The Committee even announced

that when asked what the agency’s document retention policy is, the

FDA responded “we have none!†   Not a raised eybrow…. "

 

Yet, the public and the press continue to act as if the FDA exists to

protect the public's interest! For decades the FDA has been referred

to as the Washington Branch for the phamaceutical giants. I commend

Congress for continuing to put pressure on the FDA to do what we have

been led to believe they are suppose to do - protect the public health.

 

And let me point out once again that there are TWO ongoing

Congressional investigations into these antidepressants and one Senate

investigation. With that in mind consider this:

 

-- It took only one Congressional investigation to have LSD banned

when Eli Lilly gave that drug to us as a cure for mental illness.

 

-- It took only one Congressional investigation to have the

benzodiazaphines [the Valium family of drugs] made controlled substances.

 

Clearly, with two Congressional investigations and one Senate

investigation into one group of drugs, this is one of the most

important public health issues facing this country today.

 

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

 

 

Psychiatric News October 15, 2004

 Volume 39 Number 20

http://pn.psychiatryonline.org/cgi/content/short/39/20/1

 

 

Congress Hammers FDA Over Handling of SSRIs

 

Jim Rosack

 

At press time, APA was waiting to hear whether the FDA would issue a

black-box warning for pediatric use of SSRIs. Here is a summary of the

events leading up to this strongly expected outcome.

 

 Officials of the U.S. Food and Drug Administration (FDA) first

suspected an increase in suicidal thoughts and behaviors linked to

antidepressant use in children and adolescents in March 1996†" eight and

a half years ago. Yet no apparent action was taken by the agency until

a pattern seemed to emerge in the first half of 2003.

 

 During a dramatic pair of hearings before the House Energy and

Commerce Committee's Subcommittee on Investigations and Oversight last

month, FDA officials were repeatedly put on the defensive as to whether

there existed a conspiracy to cover up the link between the drugs and

harmful behaviors.

 

 Unsatisfied with answers and explanations from agency officials during

the second hearing, at least two committee members, Rep. Diana DeGette

(D-Colo.) and Rep. Bart Stupak (D-Mich.), threatened to introduce

legislation banning the prescribing of antidepressants to anyone under

age 18 " if the FDA didn't act forcefully and swiftly to protect

America's children. "

 

 Committee members' frustration and anger seemed to have built steadily

through the first of the two hearings, which were held two weeks apart.

During the first hearing, on September 9, pharmaceutical company

executives were grilled about their apparent selective disclosure and

publication of clinical trial findings. Only four of the 15 trials of

antidepressants in pediatric patients with depression have been

published†" all with favorable results.

 

 Company executives fiercely defended their disclosure records, noting

that the vast majority of clinical trial data not published in

peer-reviewed journals†" including negative data†" had been presented on

more than one occasion as poster presentations or symposia during major

psychiatric meetings.

 

APA's Committee on Public Affairs was among the many components that

met last month in Washington, D.C., to conduct the Association's work.

More on the meetings appears on page 18 and page 19. Above are, from

left, Deborah Cross, M.D., Leslie Hartley Gise, M.D., and Britt

Peterson, M.D.

 

 

 

 However, it was FDA Acting Deputy Commissioner for Operations Janet

Woodcock, M.D., who took the heat from committee members. They charged

that the FDA had shirked its responsibility to protect the public

health by not keeping track of all the data available and ensuring

disclosure.

 

 Woodcock reminded the committee members that the FDA has little

statutory authority to compel disclosure or publication, fueling calls

for a legislated mandatory clinical trials registry (see page 2).

 

 During the second of the two hearings, held September 23, Rep. Joe

Barton (R-Tex.), chair of the Energy and Commerce Committee, emphasized

Congress's frustration with the agency. " The fact that children taking

antidepressants were experiencing psychiatric adverse events at greater

rates than adults was known at the agency as far back as 1996 and

1997, " Barton said. " I want to know what did the agency do to respond

to those concerns? "

 

 Barton was referring to a previously undisclosed letter from an FDA

reviewer dated March 19, 1996, in reference to Pfizer's data on the use

of Zoloft (sertraline) in children and adolescents with

obsessive-compulsive disorder. The FDA letter said in part, " We note

that there appears to be an increased occurrence of suicidality events

in pediatric patients exposed to sertraline in pediatric trials "

compared with observed rates in comparable adult patients. In fact,

there was a fivefold higher risk in patients taking sertraline compared

with those taking placebo. The FDA medical reviewer asked Pfizer for

" clarification and explanation " of the data.

 

 The subcommittee obtained the FDA's letter to Pfizer from the company,

not from the agency. FDA officials acknowledged that no record of the

memo was found in the agency's files. On March 28, 1996, only a week

after the letter asking for clarification and explanation, the FDA

approved Pfizer's application for pediatric exclusivity without any

apparent resolution of the medical reviewer's questions.

 

 After the application had been approved, Pfizer responded to the

agency's request. That response was retained in the FDA's files.

 

 Details also emerged about the agency's handling of a report by FDA

medical reviewer Andrew Mosholder, M.D., who had analyzed the pediatric

exclusivity data on antidepressants, submitted to the FDA as required

under the Best Pharmaceuticals for Children Act. Mosholder's report was

the first to assert openly an increased risk of suicidal thoughts and

behaviors associated with antidepressant use in children and

adolescents. While his analysis was instrumental in prompting an

advisory committee hearing in February, Mosholder was prevented from

delivering his report at that meeting.

 

 Several members of Congress, including Barton, asked numerous

questions regarding the handling of Mosholder's report and why he had

not been allowed to deliver it at the public advisory committee

meeting.

 

 Mosholder testified that after he had completed his report, his

superiors at the FDA did not agree with some of his conclusions and

recommendations†" he had not only identified an association, but also

recommended actions that should be taken regarding strong warnings for

the drugs. He testified that there was " considerable discussion " at the

agency regarding the report and his interpretation of the SSRI

pediatric exclusivity data.

 

 Robert Temple, M.D., the FDA's associate director for medical policy,

strongly defended the agency's handling of Mosholder's report. " We were

concerned about an overemphasis that could lead to a deterrent to

treatment, " Temple testified. " At the same time, we didn't want to

ignore an important signal. "

 

 Members of Congress on the oversight committee pushed Temple to

explain why the agency waited so long to issue stronger warnings on

SSRI use in children, when the agency had Mosholder's report since mid

2003.

 

 " We had questions that were not answered to our satisfaction, " Temple

said. " We were not worried about [Mosholder's] analysis of the data,

but we had significant questions about the credibility of the data he

had available to analyze. We decided to withhold any agency opinion on

the issue till everything possible was known. "

 

 The FDA then decided to seek the independent reanalysis of the data by

suicidality experts at Columbia University, Temple said. " We had no way

of knowing what the reanalysis would bring†" whether it would strengthen

or weaken [Mosholder's] conclusions. We really had no preconceived

notions, no preference. "

 

 Meanwhile, by late spring both House and Senate committees began

investigating the FDA's handling of the issue. Members of Congress

began expressing a sense of frustration over what they characterized as

" a slow and obstructive response. "

 

 " The FDA's lack of cooperation with the committee in obtaining

relevant and responsive information in a timely fashion on a matter

that involves the safety of our children leaves me wondering whether

this is sheer ineptitude or something far worse, " Barton noted during

the first of the two hearings in September.

 

 

 During the second hearing, it was revealed in documents released by

the committee that on at least one occasion, documented in internal FDA

e-mails between Mosholder and his superiors, Mosholder was advised to

change his conclusions, deleting material on the risks. An FDA attorney

then advised him to conceal the change when asked to submit documents

to Congress.

 

 " I don't think it's necessary to indicate this document represents a

version of the earlier one by noting that things have been omitted;

that simply invites the committee to ask further questions about what

was omitted, " wrote Donna Katz of the FDA's Office of Chief Counsel in

an e-mail to Mosholder.

 

 The Columbia analysis, which took roughly four months, was reviewed by

an internal FDA Office of Drug Safety medical officer, Tarek Hammad,

M.D. Hammad's conclusions mirrored those of Mosholder: there is roughly

a one-and-a-half to twofold higher risk of suicidal thoughts and

behaviors in children and adolescents taking certain antidepressants.

 

 " We had to proceed cautiously on such an important matter, " Temple

emphasized. " To get it wrong would create more problems than we could

hope to solve. "

 

 The Columbia analysis, he added, helped to determine that the data

that Mosholder had analyzed were valid and, therefore, that his

conclusions were valid.

 

 Following the second advisory committee hearings, on September 13 and

14, several members of the subcommittee pressed Temple to disclose what

the FDA's final position would be (see article at right).

 

 " Stating that the drugs are associated with, linked to, or cause

suicidal thoughts and behaviors in pediatric use is a given, " Temple

said. " What is at question is what form that warning will take. It

could be a black box; it could be a bolded warning within the warnings

section of the full label. "

 

 Stupak shot back, " When are you finally going to decide? "

 

 Temple replied that a decision would be made " within a few days. "

 

 " But if these drugs don't work well in kids, and they increase

suicidality in kids, why does the FDA allow them to be prescribed to

kids? " Stupak asked. " Can't the FDA ban prescribing them to children? "

 

 " We could contraindicate their use, " Temple replied, " but we don't

think that would be particularly helpful in protecting the public

health. "

 

 Temple emphasized more than once during his testimony that the agency,

as well as members of the advisory committees, had been reluctant to

contraindicate antidepressant use in children out of fear that

children who need care would not get it.

 

 " Two-thirds of the [members of the committees] voted in favor of a

black-box warning, " Temple emphasized, adding that when a committee

vote is split, the agency does not automatically go with the

majority†" it must deliberate the pros and cons of each position and

determine the best course to take.

 

 " There's no question there will be a strong warning, " Temple said. " We

need a patient med guide, and the drugs need to be in unit dose

packaging. " That way, he explained, the warning language required in

labeling would be assured of getting to each patient taking the

medications at issue.

 

 " The only thing we are still thinking about is the box, " Temple

concluded. " All the rest of the advisory committee's recommendations

will be implemented. "