BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception

BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception

Sun, 3 Oct 2004

BBC-Panorama is airing its third in a series of investigative reports about the betrayal of trust in psychiatry, drug manufacturers and government regulators.

The first program, The Secret of Seroxat, aired October 13, 2002, revealed in case after case, that Paxil / Seroxat caused severe adverse drug reactions–including previously unreported suicides.

Public response to the program–and the thousands of people who reported their horrific experience on the drug, forced the British Medicine authority to convene an expert panel to examine the data. However, revelations of the panelists’ conflicts of interest forced the agency to disband the first panel and convene a second panel.

When confronted with the previously concealed evidence of harm–particularly harm to children and adolescents for whom the drugs had not shown a benefit in clinical trials–led the British to prohibit the use of antidepressants for children, except Prozac.

This exception is inconsistent with Eli Lilly’s UK Prozac label which specifically notes:
NOT RECOMMENDED FOR CHILDREN.

The action taken by UK regulators who were under pressure from the public, led the FDA to analyze the pediatric clinical trial data that the agency had ignored for years.

Tonight’s program focuses on the collusion between UK government regulators and GlaxoSmithKline.

Dr Mike Shooter, President of the Royal College of Psychiatrists, said of the Seroxat issue: “It has serious implications for the whole of psychiatry, it has serious implications for the whole of medicine.”

“I think a few years down the line we are going to be talking about this with many more sorts of medication.”

Indeed, Merck’s belated withdrawal of Vioxx from the market is yet another example of the regulatory system’s failure to protect the public.

But, as Panorama will show, the regulatory system is made up of officials, and those officials have been complicit in concealing the truth. They should be held accountable for the lives lost because of their failure to reveal the facts.

FDA officials have failed to protect the public from hazardous drugs–including drugs that increase heart attacks, and drugs whose adverse effects are so severe that some people are driven to commit suicide. FDA officials have lied under oath and they should be held accountable. FDA officials have intervened in court to shield drug manufacturers from being held accountable for concealing evidence of harm, and making false advertising claims. They should be held accountable.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://news.bbc.co.uk/go/em/pn/-/1/hi/programmes/panorama/3677792.stm
SUNDAY OCTOBER 3 22:15 BST – BBC ONE
Taken on Trust

We take it on trust that the drugs our doctors prescribe are safe and effective.

But this special investigation exposes huge failings in the system of medicines regulation that is supposed to monitor drug safety.

It reveals how patients’ lives have been put at risk as a result.

For the last two years, Panorama has been investigating claims that Seroxat can cause addiction, self-harm, aggression and even suicide.

The medicines regulator always denied there was evidence to back up these claims.

But now the programme reveals that, not only is the evidence there, it’s been lying dormant in the regulator’s archive for at least 13 years.

One insider tells the programme: “I have little confidence that the drugs they’re licensing day by day are being licensed in a way that I would feel appropriate and – I have very little confidence in drugs that have been regulated in the past.”

Some of the most influential names in medicine are now asking if we’re being told the truth about the pills that we take.

Dr Mike Shooter, President of the Royal College of Psychiatrists, said of the Seroxat issue: “It has serious implications for the whole of psychiatry, it has serious implications for the whole of medicine.”

“I think a few years down the line we are going to be talking about this with many more sorts of medication.”

Forty years after the thalidomide tragedy prompted the setting up of drug safety monitoring, the regulator is accused of letting down the patients it’s supposed to be there to protect.

Tune in on Sunday to find out more.

bbc.co.uk/panorama
http://news.bbc.co.uk/go/em/pn/-/1/hi/programmes/panorama/default.stm

Related links from BBC News Online
13 October 02 | Panorama | The Secrets of Seroxat
http://news.bbc.co.uk/go/em/pn/-/1/hi/programmes/panorama/2310197.stm

11 May 03 | Panorama | E-mails from the Edge
http://news.bbc.co.uk/go/em/pn/-/1/hi/programmes/panorama/2982797.stm