Regulation in the UK – the MHRA

Here are some more ‘did you know’ moments.

It’s a surprise to many that regulation of drugs in the UK is not governed by the Department of Health. It was effectively ‘privatised’ and handed over to a body now named the MHRA which is entirely financed by the Pharmas. Its present chief executive worked for 27 years at GlaxoSmithKline, while its current Director of Licensing was Glaxo’s Worldwide Director of Safety in his last job. Regulators and industry are intimately intertwined.

The MHRA investigation into Seroxat has been heavily criticised for delays and lack of scientific rigour. Embarrassingly, the initial committee set up to look at the safety of Seroxat was force to disband after months of work. Half the ‘independent experts’ on the committee had links with GSK. Significantly and courageously Richard Brook, the mental health charity Mind’s Chief Executive at the time, resigned from the MHRA expert group on SSRIs. He said that continued membership was incompatible with Mind’s remit to represent the interests of mental health service users. He revealed that the MHRA had delayed publishing for ten years data they possessed of the dangers of Seroxat for children.

Mind has a distinguished record of tackling the might of the Pharmas. They take no money from the industry. The integrity of other charities may have been compromised; Depression Alliance admits to taking more than 80% of their funding from Pharmas in the recent past. Their mouths have been bandaged into silence throughout the exposure of the Seroxat scandal – Depression Alliance’s sole contribution to the debate was an attack on the accuracy of programmes on the subject made by the BBC’s Panorama .

Charities and patients’ groups depend on Pharmas’ cash. In a survey conducted, 18 charities involved in parliamentary lobbying said that they took donations; six refuse. Young Minds charity stated, “It is Young Minds’ policy not to enter into financial partnerships with Pharmaceutical companies. This enables the organisation to maintain its independence and avoid any possible instances of compromise.”

Many of these groups provide support for Commons All-Party. No declarations of interests are currently required. The groups may be used as Trojan Horses to wield influence in parliament. Full transparency is being sought.

Marketing vs R&D

Did you know that Pharmaceutical companies spend 2 – 3 times as much on marketing their drugs than they do on research and development?

What this means is they invent awareness of conditions that can be treated by their drugs.

The ballooning demand for anti-depressants is a phenomenon.

In barely a decade depression has gone from a rare disorder to being classed as the second major affliction of humankind. Can a thousand-fold increase be explained other than as deliberate marketing ploy to medicalise unhappiness? A new disease of social phobia has been invented, packaged and sold along with its anti-depressant cure. The repeated claim that drugs correct a faulty ‘chemical balance’ in the brain is a theory that has no scientific base. But millions of prescriptions are issued without any test of brain chemical activity. In the USA ten million children are dosed up with antidepressants. That includes 2 million prescriptions for Seroxat.

Pharmas have cynically created dependence on happy pills. Their fable is that life should by perpetual euphoria from cradle to grave. We have been conditioned to believe that if we feel sadder today than we felt yesterday, we are sick. Stress and depression are swelling epidemics in prosperous Western countries. The impoverished developing world has other things on their minds. But unhappiness, boredom anxiety even grief and despair are the inevitable trials of the human condition. They are to be endured not to be smothered with a drug. Grief suppressed is grief multiplied. Without misery, we would not recognize happiness. Most works of art are the products of anguish. If Beethoven and Michelangelo had been on SSRIs their creative animus would have withered.

This is the Pharmas’ greatest success in disease mongering and medicalising society. Their aim, expressed to Paul Flynn MP in a letter from GlaxoSmithKline (GSK) is that half of the population of the UK should be on anti-depressants at some time in their lives.

A drugged nation delivers bounteous Pharmas profits.

Glaxo HAS suppressed Paxil suicide data – and admits it!

On February 27, 2006, an excerpt from a previously sealed product liability report against GlaxoSmithKline (GSK) was made public. The medical expert report documents how the company systematically hid and manipulated data concerning Paxil-induced suicidality in depressed adults. The number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated.

The entire product liability report is reproduced on www.breggin.com. It further documents how GSK hid the incidence of Paxil-induced akathisia (agitation with hyperactivity) and stimulation. Akathisia and stimulation are risks factors for suicidality and violence. The product liability report also cites previously unreleased FDA correspondence critical of GSK’s marketing and advertising tactics in regard to Paxil.

The excerpts were published as part of a Special Report by Peter R. Breggin, M.D. in Ethical Human Psychology and Psychiatry (Volume 8, Spring 2006, pp. 77-84).  Dr. Breggin’s original psychiatric expert report was written for Lacuzong v. GSK and signed as an affidavit in California on July 21, 2001.  It was based on a three-day examination of GSK’s sealed files at the company headquarters.
 
The Lacuzong case was brought by the widow of a man who drowned their two children and himself in a tub after taking Paxil for three days.  The attorney was Don Farber of San Rafael, California.

The Lacuzong case was “resolved” to the satisfaction of the family; the drug company denied all allegations. At GSK’s insistence, Dr. Breggin’s report remained sealed. However, in a more recent case against the company, Moffett v. Glaxo SmithKline, the United States District Court for the South District of Mississippi, the report was filed in the public record and is now available at the court as well as on www.breggin.com.
The FDA has recently issued a preliminary warning that newer antidepressants like Paxil may cause increased suicidality in adult patients. The FDA is planning further scientific review but, as this special report indicates, drug companies do not always reveal critical data to the agency.

Dr. Breggin stated, “The drug companies settle almost all legal cases brought against them in order to seal incriminating scientific data.  This deprives the FDA, medical profession and public of critical information on drug safety and efficacy. The publication of a previously sealed medical expert report is a rare event—the first in my experience. The law should be changed to require drug companies to publish all of the safety and efficacy data they generate in regard to their drug products.”   

In May 2006, in a move that had nothing at all to do with Dr Breggin’s report being made public, of course, GSK made a stunning admission.

In a release in collaboration with the manufacturer GlaxoSmithKline (GSK), the FDA acknowledged the antidepressant Paxil caused a statistically significant increased rate of suicidality in depressed adults as measured in controlled clinical trials. The results are based on a re-analysis of all adult controlled clinical trials that compared Paxil with placebo.

Buried in the FDA/GSK release was an astounding fact: Depressed people are 6.4 times more likely to become suicidal while taking an antidepressant than while taking a sugar pill.

SSRIs do cause suicide in ‘young adults’

On December 13, 2006 the FDA’s Psychopharmaceutical Drugs Advisory Committee (PDAC) met in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.

Now the agency admits the drugs cause the same disasters in young adults. Meanwhile, an independent review of all antidepressant trials submitted to the FDA has shown that the drugs are no better than placebo. America’s drug watchdog needs to come clean. It’s been approving depressants as antidepressants.

For Dr Peter Breggin’s detailed analysis on this please look here.

So Glaxo admits children, ‘young adults’ and pregnant women better watch out… but what about the rest of us – how long before Glaxo and the regulators come clean on this one?

The start of it all

I first took Seroxat (Paxil in the USA) in 1997. I finally decided to stop taking it in May 2004 and it then took me 22 months to slowly wean off the drug. All in all I have lost almost 10 years of my life to this drug.

I want to share with you what I’ve found out since May 2004. I’ve discovered how dangerous SSRIs can be and how dangerous the big drug companies are – especially GlaxoSmithKline (who make Seroxat).

I think at this point I must mention the drug regulators here in the UK (The MHRA) and the FDA in America. If you’re new to all this you might think they are the organisations that we can trust to keep us safe from nightmare drugs like Seroxat.

Not the case I’m afraid.

The public has been let down by them on all too many occasions. I’ve become very cynical since May 2004 and as I’ve learnt more and more and I have to say it looks from here as if the MHRA and The FDA are more concerned with protecting the Pharmaceutical companies than protecting the public.

There’s a lot of money to be made from selling new drugs to the world – a lot of money indeed. It doesn’t seem to matter if the drugs don’t quite work as well as they should or if people can become addicted to them. In the case of Seroxat, Glaxo has simply hidden trial data that shows how dangerous Seroxat really is.

In this Blog I’ll be naming and shaming the guilty and I’ll be telling the truth about Seroxat.