PFPC Daily - January 29, 2005

NOTE: While last year the Baycol story placed Bayer on "The 10
Worst Corporations of 2003 list", this year GlaxoSmithKline and
the Paxil issue were chosen...

For complete list, see:
http://www.alternet.org/story/21088/

GlaxoSmithKline: Deadly Depressing

AlterNet - Jan. 26, 2005

By Russell Mokhiber and Robert Weissman

GlaxoSmithKline, Paxil and selective serotonin reuptake inhibitors
(SSRIs): It was the story that foreshadowed and strikingly paralleled
the controversy surrounding Merck, Vioxx and Cox-2 inhibitors.

With the antidepressant Paxil (generic name: paroxetine), the story
was driven primarily from the United Kingdom, by the BBC program
Panorama and a public interest group called Social Audit. They called
attention to the severe side effects from the drugs; notably that
they are addictive and lead to increased suicidality in youth.

In 2003, the evidence of dangerous side effects had piled too high
for British regulators to continue to ignore them. In June, the UK
health experts advised that children should not be prescribed Paxil.

In February 2004, Panorama reported on internal documents from
GlaxoSmithKline (GSK) showing the company knew that Paxil could not
be proved to work in children.

In March 2004, days after the Medicines and Healthcare Products
Regulatory Agency (the UK's drug regulatory agency) advised that
Paxil dosages should be kept to low levels, an expert participating
in the Paxil review resigned, claiming the agency had possessed
evidence for more than a decade suggesting that Paxil dosages should
be kept low, but failed to act on it.

By this time, the story had started to heat up in the United States.
Dr. Andrew Mosholder, of the FDA Office of Drug Safety, had conducted
an analysis of clinical trials related to antidepressant use in
children, and found a heightened risk of suicidality. But his
superiors refused to let him present his findings to an advisory
panel convened to look at the issue in the wake of the British action.

According to an investigation by Sen. Charles Grassley, R-Iowa, the
FDA actually tried to get Mosholder to present data that deceptively
underrepresented the risk of suicidality.

Although Paxil is not approved by the FDA for prescription to
children, doctors routinely write "off-label" prescriptions for the
product for children, a practice permitted under FDA rules. More than
two million prescriptions for Paxil were written for children and
adolescents in the United States in 2002.

In April 2004, the Lancet, the prestigious British medical journal,
published a paper showing that clinical test data did show problems
with prescribing Paxil and other SSRIs to children.

In June, New York State Attorney General Eliot Spitzer filed suit
against Glaxo, charging the giant drug maker with suppressing
evidence of Paxil's harm to children, and misleading physicians.

GSK responded in a statement that it "acted responsibly in conducting
clinical studies in pediatric patients and disseminating data from
those studies. All pediatric studies have been made available to the
FDA and regulatory agencies worldwide."

Spitzer's complaint cited a 1998 GSK memo which states that the
company must "manage the dissemination of these data in order to
minimi[z]e any potential negative commercial impact."

Responding to Spitzer's suit, GSK claimed that, "As for the 1998
memo, it is inconsistent with the facts and does not reflect the
company position."

The New York complaint asserted as well that "GSK has repeatedly
misrepresented the safety and efficacy outcomes from its studies of
paroxetine as a treatment for MDD [Major Depressive Disorder] in a
pediatric population to its employees who promote paroxetine to
physicians."

In August, the company settled with Spitzer for $2.5 million, plus a
commitment to maintain the policy of posting clinical trial results,
for all drugs marketed by the company.

The next month, the Star-Ledger of New Jersey reported on a Glaxo
memo from the year before, instructing the company's sales force not
to talk to doctors about company data showing dangers from
prescribing Paxil to kids.

In October, the FDA ordered Glaxo and other SSRI makers to include a
"black box" warning with their pills. The warning says SSRIs double
the risk of suicide in children, though some medical researchers say
the number should be higher. At least one GSK clinical trial showed
7.5 percent of youth taking Paxil suffering from suicidality (versus
zero percent among those taking a placebo).

Glaxo continues to insist that it disclosed information to
appropriate authorities as soon as it discerned important results
from its clinical studies.

SOURCE:
http://www.alternet.org/story/21088/