Fwd: [SSRI-Research] Grave Concerns Over Anticipated FDA Whitewash of British Regulators' Ban on SSRIs For Children

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[sSRI-Research] Grave Concerns Over Anticipated FDA Whitewash of

British

Regulators' Ban on SSRIs For Children

 

December 12, 2003

FOR IMMEDIATE RELEASE

 

Baum Hedlund, A Law Corporation

12100 Wilshire Blvd., Suite 950

Los Angeles, CA 90025

 

 

In Response to British Regulators' Ban on SSRIs For Children

Firm Representing Thousands of SSRI Victims Expresses Grave Concerns Over

Anticipated FDA Whitewash

 

http://www.baumhedlundlaw.com/media/ssri/paxil/BH-Response%20to%20UK%20SSRI%

20ban.htm

 

Los Angeles, December 12, 2003 -- Following the United Kingdom's December

10, 2003 ban on all SSRIs (except Prozac) for children and adolescents under

18, Los Angeles-based law firm, Baum Hedlund, while applauding the UK

regulator's actions, expressed its continued skepticism that the FDA is

gearing up for a whitewash of the SSRI suicide issue in the United States.

An FDA Advisory Committee meeting is scheduled to take place on February 2,

2004 to review the SSRI suicide issue related to children and adolescents in

the U.S.

 

" There are so many reasons we have grave doubts about the legitimacy of the

February 2, 2004 meeting, " stated Baum Hedlund attorney Karen Barth Menzies,

" it's hard to begin. " For instance, according to an October 28, 2003 New

York Times article, the FDA " plans to re-examine many of the clinical

conclusions made during studies of the drugs. " In essence, the FDA will be

second-guessing the clinical judgment of the researchers who had first-hand

contact with these patients and who, at the time, determined that the

patient experienced a suicidal event and in some instances came to the

conclusion that the SSRI caused the suicidal behavior.

 

According to world renowned psychopharmacologist, Dr. David Healy, of the

University of Wales College of Medicine: " The principles of clinical trial

randomization mean you cannot post hoc analyze to look for confounding

factors. "

 

" The FDA's planned methodology can only lead to one conclusion -- the

suicidal behavior will be minimized and the whole issue will be swept under

the carpet, " said Barth Menzies. " What the FDA proposes is scientifically

illegitimate and predestined to reach a favorable conclusion for the drug

companies, " she stated. " The FDA is not looking at all of the pediatric data

to determine if some events were missed or not properly recorded. The

suicidal events can only decrease, thus there can be but one conclusion and

that is the drugs are not to blame " she concluded.

 

If that were not enough, the New York Times reports that the FDA intends to

" determine whether those given antidepressants may have been, in aggregate,

at greater risk of committing suicide than those given inert pills. If so,

the larger number of suicidal events among those given antidepressants could

be explained by their increased suicidal tendencies and not to the drugs. "

Barth Menzies stated: " The FDA is looking for ways to explain away the

higher rates of suicide, not to legitimately examine the issue. The FDA's

bias could not be more plain. "

 

The FDA has not indicated whether it will be looking into the efficacy

issues related to the SSRIs, however, this would be necessary in order to

balance the benefits vs. risks. A pivotal part of the British government's

review concerned the drugs' lack of efficacy. The question of whether these

drugs are generally efficacious has been a public issue for many years. In

fact, according to an internal memorandum written by former FDA official,

Dr. Paul Leber, there was some concern within the FDA that the approval of

Zoloft may " come under attack " because the FDA is not " as demanding as it

ought to be in regard to its standards for establishing the efficacy of

antidepressant drug products. "

 

Dr. Leber went on to state: " I have considered the fact that the evidence

marshaled to support [Zoloft's] efficacy as an antidepressant is not as

consistent or robust as one might prefer it to be. "

 

According to Leber, there were a number of studies that " found no difference

between placebo and [Zoloft] treated subjects. " Any conclusions the FDA

reaches following the February 2 meeting should include the question of

efficacy.

 

The FDA has refused to identify who will be sitting on the advisory

committee panel. Without the identities, it is impossible for the public to

determine whether and to what extent conflicts of interests exist among the

panelists. In fact, the first panel formed to look at the SSRI suicide issue

in the UK was disbanded because some members were too closely tied

financially to the drug companies.

 

See: http://baumhedlundlaw.com/media/ssri/paxil/UKReplacesTeamReSSRIs.htm

 

Another cause for skepticism is that the FDA, in the past year, has joined

forces with drug manufacturers and against consumers in SSRI litigation. For

instance, the FDA intervened in a Zoloft suicide case in favor of Pfizer,

the maker of Zoloft, after the FDA's newly appointed Chief Counsel, Daniel

Troy, received a personal telephone call from Pfizer's national counsel,

Malcolm Wheeler, asking for help. Alarmingly, Baum Hedlund learned that Troy

worked for Pfizer during the pendency of the case. The FDA also intervened

this past year to prevent a United States District Court judge in California

from forcing Paxil's manufacturer, GlaxoSmithKline, to stop airing

television commercials that proclaimed Paxil to be " non-habit forming. "

 

According to lead attorney, Karen Barth Menzies: " FDA has been violating its

own mandate to act in the interests of the American consuming public by

taking sides with the pharmaceutical companies it is supposed to police. The

problem is not only the cover-up by the pharmaceutical industry, it is the

FDA's lack of objectivity, which facilitates that cover-up. The consequences

of this complicity has, in far too many instances, led to tragedy and

death. "

 

A former FDA scientist who reviewed drugs for approval between 1995 and

2000, Michael Elashoff:, has stated: " t was pretty well understood that

if you were advocating turning a drug down -- particularly if it was from a

large pharmaceutical company -- that that wouldn't be good for your career. "

Elashoff told PBS's Frontline that he was marginalized within the agency

after he voiced his concerns about a new flu drug called Relenza.

See: http://www.pbs.org/wgbh/pages/frontline/shows/prescription/

A study released on June 1, 2003, in the Journal of the American Academy of

Child and Adolescent Psychiatry: " SSRIs have become the most rapidly

increasing psychotropic used to treat children and adolescents in the United

States. "

" According to Laurence L. Greenhill, M.D., Director of Research Unit in

Pediatric Psychopharmacology at New York Psychiatric Institute,

'SSRIs like paroxetine have become the most rapidly increasing psychotropic

drugs used to treat U.S. children and adolescents.' "

See:

J Am Acad Child Adolesc Psychiatry. 2003 Jun;42(6):627-33

Review of safety assessment methods used in pediatric psychopharmacology

See also:

J Am Acad Child Adolesc Psychiatry. 1999 May;38(5):557-65. Review.

Psychoactive medication prescribing practices for U.S. children: gaps

between research and clinical practice

NAMI's website states: " [T]he number of prescriptions for popular drugs,

such as Prozac, are rising each year, with '200,000 in the past year just

for the top four new medications.' " See http://knox.nami.org/youth/fda.htm

According to a study by Herman Van Praag published recently in " World

Journal of Biological Psychiatry " titled " A Stubborn Behaviour: the Failure

of Antidepressants to Reduce Suicide Rates, " despite the increased use of

antidepressants " completed suicide has remained quite stable " and " suicide

attempts even seem to have increased. "

In addition, a recent study published by Harvard psychiatrists Wilens,

Biederman et al. titled: " A Systematic Chart Review of the Nature of

Psychiatric Adverse Events in Children and Adolescents Treated with

Selective Serotonin Reuptake Inhibitors " found that 22% of children and

adolescents receiving SSRIs experience psychiatric adverse events (PAEs, or

" behavioral side effects " or " disturbances in mood " ).

Baum Hedlund has been litigating SSRI suicide cases for over a decade and

currently represents thousands of SSRI victims, including dozens of families

of children and adolescents who have committed suicide or attempted suicide.

The class of antidepressants known as selective serotonin reuptake

inhibitors (SSRI's) includes Zoloft, Paxil, Prozac, Effexor, Celexa, and

Luvox.

----------

----

CHRONOLOGY RE UK'S BAN OF SSRIs IN CHILDREN AND ADOLESCENTS:

June 2003:

The Committee on the Safety of Medicines (CSM) and Medicines and Healthcare

products Regulatory Agency (MHRA) announced on June 10, 2003, that " [n]ew

data from clinical trials in children and adolescents ... do not demonstrate

efficacy in depressive illness ... and show an increase in the risk of

harmful outcomes including episodes of self-harm and potentially suicidal

behavior in the [Paxil] group compared to placebo. Various analyses suggest

that the risk of these outcomes is between 1.5 and 3.2 times greater with

[Paxil] compared to placebo. " (Emphasis added.)

See:

http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/serox

at18.pdf

The announcement also stated with respect to withdrawal:

" In studies that used a tapered withdrawal regimen, symptoms reported during

the taper phase or upon discontinuation of paroxetine at a frequency of at

least 2% of patients and that occurred at a rate at least twice that of

placebo were: nervousness, dizziness, nausea, emotional lability (including

crying, mood fluctuations, self-harm, suicidal thoughts and attempted

suicide) and abdominal pain. " (Emphasis added.)

According to the Chairman of the CSM, Professor G. Duff: " [Paxil] should not

be used in children and adolescents under the age of 18 years to treat

depressive illness. " (Emphasis in original.) (Paxil is called " Seroxat " in

the U.K.)

This is the result of a review conducted by an independent panel appointed

by the UK Regulators to look into Paxil and other SSRIs (such as Zoloft and

Prozac) and their relationship to suicide and withdrawal.

The first group impaneled was disbanded after revelations that some of the

members had shareholdings in GSK and other SSRI-producing companies.

See: http://baumhedlundlaw.com/media/ssri/paxil/UKReplacesTeamReSSRIs.htm

According to Daily Mail in London, GSK may have " suppressed a series of

negative studies, " but, GSK has denied claims that it was involved in a

cover-up.

See: http://www.guardian.co.uk/uk_news/story/0,3604,974175,00.html

The independent panel is in the process of " examin[ing] urgently what

implications, if any, these data have for the use of SSRIs in adults ... "

The FDA issued its own warning about the use of Paxil in children and

adolescents on June 19, 2003, however, it has stated that it is still

examining the issue. (The UK, on the other hand, made a definitive

determination re children/ adolescents -- and stated that it is still

examining the issue of all SSRIs and suicide in both children and adults.)

GSK issued " Dear Doctor " letters to doctors in the UK, but not in the US.

August 2003:

On August 7, 2003, the New York Times reported that of the 10 experts on the

1991 PDAC panel, seven now say that " the new information [about Paxil] would

prompt them to reconsider that decision, if they were asked. "

The New York Times stated: " While the regulators' warnings address only

Paxil, many of the experts on the 1991 panel said all S.S.R.I.'s act

similarly in the body, so concerns about one could apply to all. "

According to Dr. Jeffrey Lieberman, a professor of psychiatry and

pharmacology at the University of North Carolina and member of the 1991

panel: " In 1991, we said there wasn't sufficient evidence to support a link

between these drugs and suicide. ... Now there is evidence, at least in

children, and I wouldn't rule out that it's in adults, too. "

On August 22, 2003, Wyeth, the maker of a similar drug, Effexor, issued

similar warnings to doctors in the US:

Safety and effectiveness in pediatric patients (individuals below 18 years

of age) have not been established. In pediatric clinical trials, there were

increased reports of hostility and, especially in Major Depressive Disorder,

suicide-related adverse events such as suicidal ideation and self-harm.

(Emphasis in original.)

In the meantime, on August 27, 2003, Pfizer released (knowing full well of

the investigation of all SSRIs and suicide in children and adults in the UK)

a study conducted by Dr. Karen Dineen Wagner, which, according to the author

demonstrates that Zoloft is effective and safe in children and adolescents.

This same doctor, Dr. Karen Dineen Wagner, conducted FOUR Paxil studies,

apparently never published, which formed the basis, in part, of the UK's ban

and FDA's warning re Paxil in children and adolescents.

October 2003:

An October 1, 2003 article in The Guardian, a British publication, pointed

out that, like Zoloft, " Dr. Wagner and colleagues ... concluded that [Paxil]

was effective and well-tolerated " in children and adolescents.

Dr. Wagner reportedly has now conceded, however: " I think it requires

further investigation and looking at the entire database of these

medications. "

Just last month, the CSM issued an " SSRI Factsheet, " which states:

" 5. Are SSRIs associated with a risk of suicide?

The answer: " For a small number of people, there may be an increase in

suicidal thoughts and behaviour in the early stages of treatment with any

antidepressant, including SSRIs. This is nothing to be ashamed of. If you

experience thoughts or feelings of suicide or wanting to harm yourself you

should talk to your doctor as soon as possible. "

This is the very type of warning that could have saved lives!

On October 27, 2003, the FDA issued a Public Health Advisory regarding SSRIs

and suicidality in the pediatric population, stating that " preliminary data

suggest an excess of such reports for patients assigned to several of these

antidepressant drugs compared to those assigned to placebo. " The FDA also

announced that on February 2, 2004, the FDA will hold an advisory committee

meeting, which will be open to the public, concerning the issue of SSRIs and

suicidality in the pediatric population.

Despite the above Public Health Advisory and announcement that an advisory

committee would be assembled to examine the issue, Dr. Thomas Laughren of

the FDA told a New York Times reporter: " I think probably that we have

backed off a little bit from the advisory issued in June, which recommended

against using Paxil. " (October 28, 2003, " FDA Intensely Reviews Depression

Drugs. " )

November 2003:

On November 13, 2003, PBS's Frontline aired an exposé about the failures of

the FDA in assessing the dangers of pharmaceutical drug products and

discussed the FDA's inappropriately cozy relationships with the

pharmaceutical industry. Not only should the SSRI-producing companies and

their drugs be investigated, but the FDA should be investigated as well.

(See: http://www.pbs.org/wgbh/pages/frontline/shows/prescription/)

December 2003:

On December 10, 2003, the MHRA announced that it has banned the use of all

SSRIs (except Prozac) in children and adolescents.

See http://www.guardian.co.uk/uk_news/story/0,3604,1103563,00.html and

http://www.mhra.gov.uk.

According to the UK regulators: " The commonest reason for discontinuation of

treatment [for Zoloft] was suicidal thoughts/self harm ... " In conclusion,

the MHRA stated, with respect to Zoloft: " The data show a consistently

higher incidence of suicidal thoughts and self harm in children and

adolescents with depression treated with sertraline [Zoloft], which is in

the region of twice the apparent placebo rate. " It made similar findings

related to other SSRIs (except Prozac) and stated that the risk/benefit

balance was unfavorable for Zoloft, Effexor, Luvox, Celexa, and Lexepro.

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