October 26

BBC Panorama: Unprecedented public response to evidence of SSRI drug harm

BBC Panorama: Unprecedented public response to evidence of SSRI drug harm

Wed, 21 May 2003

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/par oxetine.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

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