The blood of these children is on your [the FDA's] hands.''

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure

http://www.ahrp.org

 

FYI

 

NY TIMES Quotations of the Day:

A. " I think that we now all believe that there is an increase in

suicidal thinking and action that is consistent across all the drugs. "

Dr. ROBERT TEMPLE, of the Food and Drug Administration

 

B. " The blood of these children is on your hands.''

Mathy Milling Downing of Laytonsville, Md., whose 12-year-old daughter

hanged herself in January, said: " Candace's death was entirely

avoidable had we been given the appropriate warnings. "

 

We have turned a corner in this segment of the prescription drug war!

The Washington Post reports: " In a sharp departure from a decade-old

position, agency officials said the increase in suicidal tendencies

was not a result of the children's underlying depression but was

caused by the medications themselves. "

 

For the first time in the 20-year controversy about SSRI drug-induced

suicidal acts in some people--a battle has been won!

 

First, the FDA acknowledged a causal link between SSRIs and suicidal

behavior: " If 100 children and teenagers are given the drugs, two or

three will become suicidal who would not have been suicidal if given

placebos. "

 

Second, AHRP's unequivocal demand for a black box warning requirement

*[see below]-a demand of families who testified as well--has been

recommended by FDA's advisory panel. All antidepressant drugs will

have to carry a black box warning about the suicidal risk on the

label and on consumer package inserts.

 

However, the issues that were brought to a head in the SSRI children

debacle continue to plague the process of drug testing, data

disclosure, safety and efficacy assessment, and drug approval. The

FDA's complicity in years of deception cannot be underestimated.

 

1. WHY DO PUBLIC OFFICIALS WITH INSIDER INFORMATION---who are closest

to the smoke alarms--wait for outsider critics to report the fires?

 

FDA officials have deliberately engaged in paralysis through

analysis--i.e., the Columbia University reclassification was simply a

delay tactic that added nothing toward improving children's safety. It

is FDA's responsibility to establish a unified consistent adverse

event classification system and to require drug manufacturers to use

it. However, FDA officials turned a blind eye whereas every

independent knowledgeable analyst recognized the cluster

of red flags without the Columbia classification scheme.

 

The Associated Press reported [below]: " Dr. Robert Temple, director of

the FDA's office of drug evaluation, told reporters he had no regrets

delaying the testimony at a previous hearing because he still thinks

Mosholder's data may be flawed. "

 

Does no one bear responsibility for putting additional children in

harm's way because of an unjustifiable unconscionable delay in warnings?

 

2. WHY DOES THE PRESS BEHAVE LIKE DEFERENTIAL LAP DOGS VIS A VIS

AUTHORITY FIGURES?

 

Inasmuch as senior FDA officials have made numerous safety and

efficacy claims that proved to be unsupported by the evidence-some

would call these pronouncements deliberate lies--it is odd that

members of the press have failed to question FDA officials about the

charge that suicides had occurred in adult clinical trials. Evidence

about those suicides was presented at

AHRP's press briefing by a foremost authority on the subject. Indeed,

Dr. David Healy's analyses of both the pediatric and adult data have

forced the FDA to re-evaluate the data that has been concealed in

FDA's files.

 

But then, the press had similarly failed to follow up on the

suppression of Dr. Andrew Mosholder's report--even though its

suppression was announced at the Feb. 2 advisory meeting. Indeed, the

press did not wake up to the Mosholder muzzling, nor the significance

of the SSRI children debacle until two congressional committees began

investigations-and only after New York State Attorney General Eliot

Spitzer charged GlaxoSmithKline with fraud.

 

3. WHY IS " the Fourth Estate " DISINCLINED TO GO AFTER THE HYPOCRISY

LURKING BEHIND CONFLICTS OF INTEREST?

 

The FDA waived financial disclosure requirements for advisory panel

membersand excluded any independent authorities in psychopharmacology

who haveanalyzed the data and raised the issue of unreported suicides.

Furthermore, FDA withheld all published scientific analyses of the

SSRI data by knowledgeable independent experts who would have brought

greater clarity to the discussion. The FDA's failure to conduct a fair

and open debate--with all sides of the debated represented--is endemic

to the culture of secrecy and concealment. FDA's suppression of

evidence and exclusion of independent experts who have additional

evidence, were calculated to create confusion and uncertainty.

 

Observers noted that two of the most outspoken opponents to warnings

onantidepressant labels were Dr. Matthew Rudofer and Dr. Daniel

Pine-they arepublic officials at the National Institute of Mental

Health (NIMH).

 

Their position reflected NIMH's bias toward expanding psychotropic

drug usein children and adults, and the agency's defense of industry's

products.

NIMH and its psychiatrists have unacknowledged financial relationships

withpharmaceutical companies.

 

WHO HAS WHAT TIES TO WHOM?

These three strands can be found in each and every one of the

revelationsthat the Alliance for Human Research has brought to public

attention.

 

Ed Silverman of The Newark Star Ledger put the SSRI debacle in proper

perspective: " The recommendations cap more than a year of escalating

controversy overantidepressants, which generated more than $11 billion

in retail sales lastyear and include well-known names such as Zoloft,

Paxil and Effexor.

Scientists, parents and politicians have weighed in on a debate that

startswith a basic question: Do these drugs help or hurt? "

 

" The controversy may not be over, though. Congressional inquiries are

underway, and momentum is building to require drug makers to register

theirclinical trials with a national registry. A hearing by a House

panel is scheduled for next week on the FDA's handling of the issue. "

 

The AP reported on Sept. 14: " The FDA isn't bound by

advisers'recommendations but usually follows them. FDA drug chief Dr.

Robert Templesaid a decision could come within months but noted

advisers were divided,making it " less of a sure thing. "

 

In light of FDA's record of inaction and its willingness to sacrifice

children's lives to maintain sales goals, AHRP believes that mandatory

legislative requirements are essential to ensure enforcement of safety

warnings.

 

* AHRP recommendations for immediate FDA action submitted to the FDA

advisory committee:

 

(1) information concerning the increase in suicide-related events

associatedwith exposure to antidepressants in pediatric clinical

trials be placed atthe front of product labels of antidepressants of

the SSRI and SNRI class;

 

(2) this information should be contained in a bold black box warning

in theproduct label;

 

(3) manufacturers of SSRIs (selective serotonin reuptake inhibitors)

andSNRIs (selective norepinephrine reuptake inhibitors) should be

required tosend " Dear Doctor " letters to the nation's physicians

detailing the risk ofsuicide-related events associated with their

products, reminding physiciansthat these products have not

demonstrated a benefit for children and havenot been approved by the

FDA for pediatric use.

 

[AHRP's written comments--FDA's Waiting Game Exposes Children to

PreventableRisks-will be posted on our website shortly--as will the

presentations ofthe panel of experts from AHRP's press briefing.]

 

An excellent article in The Denver Post, See:

http://www.denverpost.com/Stories/0,1413,36%257E11676%257E2394179,00.html

 

Press reports about the advisory committee meeting:

 

New York Times:

http://www.nytimes.com/2004/09/15/health/15depress.html?ex=1096261888 & ei=1 & en=2f\

7cda406440db68

 

Associated Press:

http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/091504dnnatant\

idepress.ada45.html;

 

Washington Post:

http://www.washingtonpost.com/wp-dyn/articles/A21780-2004Sep14.html

 

Bloomberg News:

http://quote.bloomberg.com/apps/news?pid=10000006 & sid=aZtKtuO_ZC6Q & refer=home

 

Denver Post:

http://www.denverpost.com/Stories/0,1413,36%257E11676%257E2402182,00.html#

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

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