May 23, 2003
Public Response to The Secret of Seroxat
In a stunning follow up to its investigative report, The Secret of Seroxat,
aired October 13, 2002, the British Broadcasting Company (BBC) featured the
public responses to its earlier program as the focus of its Panorama program
on Sunday May 11. The focus was on severe adverse drug reactions--including
previously unreported suicides--in patients prescribed Seroxat (Paxil,
Paroxetine), one of the SSRI antidepressants.
http://news.bbc.co.uk/2/hi/programmes/panorama/2982797.stm
[The program received extraordinary approval from the British
press see:
http://news.bbc.co.uk/2/hi/programmes/panorama/press_reviews/2798203.stm
]
For years, drug manufacturers and regulators (in the UK and US) have
maintained that antidepressants reduce the risk of suicide. But Dr. David
Healy, Director, North Wales Department of Psychological Medicine, a
psychiatrist with an international reputation (author of 12 books and 120 peer
reviewed articles), an expert in psychopharmacology, disputes those claims. He
examined confidential internal company documents to which he gained access in
his capacity as an expert witness in a lawsuit against GlaxoSmithKline. These
internal documents, Dr. Healy says, show the results of the company's own
clinical trials testing Seroxat (Paxil, Paroxetine), an antidepressant
classified as a selective serotonin reuptake inhibitor (SSRI). The evidence,
Dr. Healy says, shows that RATHER THAN REDUCE THE RISK OF SUICIDE, THE DRUG
INCREASES THE RISK.
"The evidence is that roughly one person in sixty that goes on this drug makes
a suicide attempt. Now you have to contrast that with the people going on
placebo or sugar pill, and the rate there is one person in five hundred and
fifty. That's nine or ten times less. The risk on the drug is nine or ten
times greater than the risk on sugar pill." Dr. Healy says this data was known
to both the drug company and regulators in the UK and US for 13 years. Neither
the British Medicine Authority nor the American FDA have disputed these
claims.
Following its October 13, 2002 broadcast, BBC received an avalanche of
response from viewers: close to 1,400 e-mail reports and over 5,000 telephone
calls--mostly from people who had suffered drug withdrawal symptoms and
thought they were alone. The e-mails were analyzed by independent experts and
the findings were then forwarded to the British Medicine Authority.
A published medical report analyzed 1,374 e-mails:
234 reports [17%] rated paroxetine (Paxil, Seroxat) "very positive to “worth
taking";
647 reports [48%] rated paroxetine negative from not worth taking to severely
disabling);
469 reports [35%] were uncertain, giving no or insufficient evidence of having
taken paroxetine.
See:
http://news.bbc.co.uk/1/shared/spl/hi/programmes/panorama/paroxetine/pdf/paroxetine.pdf
BBC continues to catalog additional e-mail reports it receives and to
report these to the British Medicine Authority.
Dr. Healy is one of the few psychiatrists who has gone to battle on behalf of
patients' right to know the risks and adverse side effects that may result
from SSRI drugs. He has challenged the drug manufacturers to disclose the side
effects known to them to patients and physicians so that lives can be saved.
He told BBC that he had mixed feelings about the public outpouring: "I'd been
hearing essentially similar stories for 12 years now and against that
background the fact that people had been as isolated in their suffering as
they have been seems unconscionable."
He suggested that Glaxo SmithKline should sponsor a forum "where doctors faced
with patients faced with these problems can begin to realize that they the
doctors are not on their own and that maybe through their collective efforts
they can come up with insights on how best to handle the problems."
Among the individual tragedies reported by BBC was Rhona Aldred, a woman
diagnosed with depression by her doctor in October 2001, and prescribed
Seroxat. She kept a daily record in her diary of how she was feeling while
taking the drug. After 11 days she committed suicide.
In a riveting moment in the program, BBC asked: "Did Seroxat kill Rhona Aldred?"
Dr. Healy replied: "Yes, I think you can be pretty confident that it did. Her
death happened within the classic timeframe of deaths that happen on this
group of drugs. She had nightmares, restlessness, mood swings, all of which
occurred very quickly after she went on the drug, and I think can make all of
us fairly confident that yes, if she hadn't had this drug, she wouldn't have
killed herself and she would be here now today."
Adults are not the only tragic victims of adverse drug effects. BBC reported:
"Among the most disturbing patient reports were 23 about children who'd had a
terrible time on the drug. Seroxat has not been approved as safe for use in
under 18s but doctors are allowed to prescribe it to them if they think it may
help them."
When confronted by BBC's Shelly Jofrey, "in the carefully done study, it was
the biggest study of its kind in America, more children became suicidal on
Seroxat than on placebo – sugar pills"
Dr. Alistair Benbow, of SmithKlineGlaxo acknowledged: "Yes, that may be true
in that particular study, but if you look at…"
JOFREY: Well that's pretty worrying, isn't it?
BENBOW: "No, that's part of the pieces of evidence that we have to gather
together to decide together with the regulatory authorities and obviously they
are the appropriate people to assess this.
They will look at all the data that's been generated in children."
JOFREY: "The Medicines Control Agency relies on clinical trial data to work
out whether a drug is safe to be prescribed. In the 1960s it was thalidomide,
a very different drug to Seroxat, that highlighted the need for medicines to
be monitored for side effects long after they've been approved as safe."
In light of the BBC disclosures about the suicide evidence, it is unlikely
that the British Medicines Control Agency will approve SSRI antidepressants
such as Paxil (Seroxat) for children. American children aren't so lucky. The
US Food and Drug Administration ignored the evidence in its own files about
the suicide risk and approved SSRIs for children.
BBC reported: "Most damning of all, Panorama has discovered that the number of
suicides that may be linked to Seroxat has been significantly underreported to
the regulator." FDA officials acknowledge that FDA receives reports for only
1% to 10% of actual adverse drug reactions.
The major American news media--including public television--are averting their
gaze from a public health menace that needs to be investigated. What keeps
America's major news media from conducting an investigation that would shed
light on the scope of the problem in America, where most of the psychotropic
drugs--including SSRI antidepressants--are sold?
How many Americans are suffering from drug-induced dependency and severe
withdrawal symptoms? How many American may have been driven to suicide as a
result?
Perhaps, major newspapers such as The New York Times--which claim to publish
"All the News That's Fit to Print"--are reluctant to investigate the drug
industry lest such reports threaten their advertising revenue.
Equally deafening is the silence of the psychiatric community. Neither the
American Psychiatric Association, or the American College of
Neuropsychopharmacology have addressed the problem of drug-induced suicide
either in their journals or conferences.
Those who are in possession of the facts--including the FDA-- are suppressing
vital information from clinicians who prescribe these drugs without knowledge
of their potential lethal side effects, and from millions of people who take
them even for minor discomforts.
BBC Panorama:
See complete Transcript of May 11, 2003. From the Edge:
http://news.bbc.co.uk/nol/shared/spl/hi/programmes/panorama/transcripts/emailsfromtheedge.txt
Complete Transcript of October 13, 2002. The Secrets of Seroxat:
http://news.bbc.co.uk/1/shared/spl/hi/programmes/panorama/transcripts/seroxat.txt
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav
212-595-8974
e-mail: veracare@ahrp.org
Last Updated on
04/14/04
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