Taverne/Glaxo/Nukes/Crick/Regulatory cover-ups (4/8/2004)

Items 2-3 relate to UK regulatory cover ups and what happens to advisory committee members who dissent.

Final item refers to W. French Anderson, the University of Southern California researcher who has been leading the charge on both somatic and human germline gene therapy

A question of ethics:
1.Taverne's conflict of interest
2.Why I resigned over 'happy pill' cover-up
3.Agency blamed for promoting Seroxat
4.Government gags experts over nuclear risks
5.Life, the universe...and nothing - Francis Crick,
6.Gene therapy pioneer W.F. Anderson arrested on molest charges

1.Taverne's conflict of interest

Lord Dick Taverne recently contributed a pro-MMR (measles, mumps, and rubella) vaccine article to the British Medical Journal in which he argues against legal aid being granted for a claim against its manufacturers.

In the article he is billed as the Chairman of Sense about Science. The BMJ requires disclosure of interests. Glaxo SmithKline is a major vaccine manufacturer and, specifically, an MMR manufacturer. Taverne fails to mention any link between Sense about Science and Glaxo even though the company is listed as one of the lobby group's donors.

2.Why I resigned over 'happy pill' cover-up
by RICHARD BROOK, Daily Mail
23rd March 2004

Last week I resigned from the Government's watchdog on anti-depressants after it tried to cover up its own ten-year failure to identify serious side-effects of the controversial drug Seroxat.

The Medicines and Healthcare Products Regulation Agency found from information that had been in its possession for more than a decade that high doses of the anti-depressant can lead to aggression and thoughts of suicide.

But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings.

Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.

Mind, the mental health charity, has been tracking Seroxat for a decade and found it to be the most problematic anti-depressant. Side-effects include nervousness, aggression, irrational thoughts and, in some cases, feelings of suicide.

Although Seroxat has been effective for thousands suffering from severe depression, there are many who blame tragic events, including murders and suicide, on it. Last year, BBC's Panorama showed that - despite denials from the manufacturer - people can get hooked on Seroxat and suffer terrible withdrawal symptoms when trying to come off it.

Manufacturer played down side-effects

The drug's manufacturer, GlaxoSmithKline, has sought to play down its side-effects, denying until last year that it could be addictive. Mind - along with dozens of people suffering the drug's side-effects - held a demonstration last June outside MHRA's headquarters in London, calling for the drug regulator to take action.

By the end of that week, I had been invited to join its expert panel to look at the effectiveness of the so-called "happy pills", selective serotonin re-uptake inhibitors (SSRIs) - drugs prescribed to tackle depression, anxiety and other psych-ological problems. They include Prozac and Seroxat.

I hoped we could issue clear guidance to doctors on how to prescribe SSRIs safely. But my colleagues at the regulator, all from the medical establishment - doctors, academics and psychiatrists - had different ideas. They appeared more interested in putting their reputations, and those of drugs companies, before the safety of patients.

In October, the MHRA reviewed data from the earliest trials of Seroxat. The information was supplied by GlaxoSmithKline in the late Eighties, and it was the MHRA's responsibility to analyse the statistics to inform its decisions.

In four reviews of these statistics over ten years, the regulator had failed to pick up the vital information that any dose of Seroxat above 20mg a day doesn't work any better but significantly increases the side-effects.

Hundreds prescribed dangerous levels

Some 17,000 people were prescribed more than 20mg of Seroxat last year. But the panel wanted to kick the findings into the long grass, passing it to European regulators. It would take months. In that time, hundreds would be prescribed dangerous levels of Seroxat.

It was then that Professor Woods made clear I faced prosecution if I revealed what the regulator had found, citing the need to protect the "commercial confidentiality" of drugs firms.

On the MHRA website, Professor Woods defends the watchdog, saying its advice is backed by clinical data.

A few days later, I went to see Health Minister Lord Warner to tell him of my concerns. He said he would speak to the regulator, and soon after they reluctantly published the findings.

Their statement "reminded" doctors not to prescribe more than 20mg, as if it had been common practice all along. Previously, the MHRA's recommended "safe" dose was 20mg to 50mg a day.

I resigned. If a regulator will not own up to its mistakes, who knows if data about other drugs has not also been overlooked, with potentially fatal results.

Regulators are supposed to be a stop-check for safety issues. But at the MHRA, many of the people who work there or advise it have ties to drugs firms. Some have shares in the companies, research departments funded by them or receive fees for advice.

The only protection is a musical chairs system where you leave the room if you have an interest in the drug being discussed or its manufacturer, or you can stay but not vote.

Need for independent inquiry

There is an urgent need for an independent inquiry into the MHRA. The Government must also change its culture of secrecy.

Seroxat is far too extensively prescribed, especially for mild and moderate depression. But anti-depressants - including SSRIs - do work, and can prevent suicides in severe cases. However, they are not wonder drugs.

GPs should clearly outline all the options to sufferers and anti-depressants shouldn't be the automatic answer. If vital information such as that the MHRA tried to cover up is not released, these decisions cannot be fully informed.

Likewise, patients on Seroxat concerned by my findings should consult their doctor before adjusting their medication.

Mind does a lot of work with the Government, and we have a good relationship. But I am very concerned that I was put under such pressure not to reveal the regulator's findings.

My only hope in speaking out is that the regulator will change. It must listen to people suffering negative side-effects of drugs and to be more accountable to patients rather than to pharmaceutical companies.

Dr Alastair Benbow, European medical director at GlaxoSmithKline, says: "We remain fully confident in the effectiveness of Seroxat, an important medicine that has helped many millions around the world lead fuller lives."

3.Agency blamed for promoting Seroxat
Seroxat: more harm than good
10:07am 8th May 2003
The body which regulates medicines is playing Russian Roulette with people's lives over the common antidepressant drug Seroxat, a charity claimed today.

Mental health charity Mind said the Medicines Control Agency - now the Medicines and Healthcare products Regulatory Agency - had failed in its duty as the body responsible for the safety of prescribed drugs.

Seroxat, which is manufactured by GlaxoSmithKline, is one of the most commonly prescribed antidepressants.

But some who have taken it have claimed they became hooked on the drug, while others have reported feelings of self harm, or even suicide.

Mind chief executive Richard Brook said the MHRA had not listened to the experiences of people who had taken Seroxat.

"Many of these people have suffered terrible side effects when taking or trying to come off the drug and some people, it is believed, have died," he said.

On Monday, Mind and people who have taken Seroxat, will protest outside the offices of the MHRA in London.

Mind is calling for Seroxat not to be issued for new prescriptions until a full and independent inquiry has been conducted involving people who have taken the drug.

The charity is demanding urgent meetings with health minister Hazel Blears, GlaxoSmithKline, and the Royal Colleges of GPs and Psychiatrists. It also wants discussions about stronger warnings of potential side effects on information leaflets and better training for doctors.

In October the documentary series Panorama raised concerns about Seroxat and the BBC was contacted by thousands of people who had taken the drug. Of these, 239 agreed to take part in a survey about their experiences.

Some 97% reported unwanted side effects and 50% of these said they had had feelings of self harm or suicide.

Withdrawal problems were experienced by 83%, while 66% of those who tried to stop taking the drug said they felt unable to do so. Of the 55% who asked their doctor about side effects, 31% had been told there were no side effects and 39% were informed that the drug was not addictive.

Currently members of the medical profession can report adverse drug reactions to the MHRA's yellow card scheme.

But Mr Brook said the BBC had received more reports of problems than the official yellow card scheme. He called on the MHRA to promote its yellow card scheme more widely.

A spokeswoman for GlaxoSmithKline said since its launch Seroxat had helped tens of millions of people worldwide with depression to lead fuller and more productive lives.

She also said suicide was a potentially avoidable consequence of depression, and Seroxat could therefore help prevent it.

"This is probably one of the most extensively investigated medicines that is available in the UK today and like all medicines is subject to continuous ongoing safety monitoring," she said. "Information from patients about how they have responded to treatment and the impact the treatment has on them is extremely important and is something that GSK takes very seriously."

She added that for patients the most important source of information was their doctor as he or she knew the individual's background and what was the best treatment for them.

4.Government gags experts over nuclear plant risks
Mark Gould and Jonathan Leake
The Sunday Times
August 01, 2004

A BITTER row has broken out inside a government safety committee after two of its experts were barred from voicing fears that radiation from nuclear installations poses a greater threat than previously thought.

Government lawyers have blocked a minority finding written by the two from being included in the committee's final report - which follows a three-year investigation into the effects of low-level radiation.

Dr Chris Busby and Richard Bramhall, members of the committee examining radiation risks from internal emitters, believe that the risk of cancer from low-level radiation dangers is greater than realised.

They claim that previous methods of calculating the effects of emissions on people living near nuclear installations have underestimated the risk by a factor of up to 300.

If correct, the study could explain the clusters of cancer and leukaemia cases found close to nuclear installations in north Wales and Essex and near Sellafield in Cumbria. But the claims have divided members of the committee, with some supporting the gagging while others have accused civil servants of censorship.

A senior radiation scientist has already resigned in protest and the last meeting of the committee became a shouting match that members feared was going to degenerate into a fist fight.

The committee's official report - which has majority support - will be published this autumn and says the risk is greater than previously thought, but only by a factor of 10.

Lawyers at Defra, the environment ministry, have sent letters to all 12 members of the committee warning them that they could be sued for defamation if they include Bramhall and Busby's minority report.

Michael Meacher, who set up the committee while he was environment minister in 2001, is furious that not all the experts' views will be represented. "I have written to Elliot Morley, the current environment minister, asking for an explanation," he said.

The committee was created to examine concern that the government's method of estimating the risk of cancer to people living near nuclear installations was inadequate. Such calculations were based on the radiation doses received by casualties from the Hiroshima bomb used against Japan in 1945.

There have long been doubts about such data, partly because they are so old and partly because Hiroshima victims were exposed to a short and very intensive dose of external radiation. By contrast, people living near nuclear sites tend to experience a different form of radiation - suffering small doses over a long period of time from eating or breathing contaminated particles.

Such radiation is thought to do proportionately more harm because it is inhaled or ingested and so can directly attack the body's most delicate organs.

Recognising the complexity of the science, Meacher set up the committee with representatives of the nuclear industry, green groups and independent scientists and asked them to include a range of views in their findings, including any minority reports.

Busby and Bramhall say that since Meacher was sacked the committee has been taken over by people with pro-nuclear views who have done their best to suppress opposing opinions.

"The basis of these calculations is completely wrong and as a consequence people living near Sellafield and other installations have been suffering elevated rates of cancers and all sorts of other diseases," Busby said.

"The other members of the committee and Defra may not agree with our report, but they should still be publishing it."

Some other committee members disagree. They point out that both men are ardent anti- nuclear campaigners and claim that their report was riddled with inaccuracies.

"The extreme views held by these two meant that the committee became completely polarised with members shouting at each other in anger and exasperation," one said. "In the end we could not be associated with a minority report that was factually wrong, so it was referred to the lawyers."

Fears that the committee is being gagged are echoed by Marion Hill, a senior scientist with 30 years' expertise in radiation safety.

Hill, who emphasises that she is not a member of the green lobby, resigned from the committee in February. In her letter of resignation she accused the committee chairman, Professor Dudley Goodhead, and Ian Fairlie, another member of the secretariat, of biasing the report process so that Busby and Bramhall's views were marginalised.

She said yesterday: "It's a complete failure when you have a scientific committee that is not allowed to write anything about disagreements over science."

5.Life, the universe...and nothing
Did Francis Crick, who died last week, discover the secret of life? It will take more than DNA to do that
Bryan Appleyard
The Sunday Times
August 01, 2004

'Francis," wrote James Watson in his book The Double Helix, "winged into the Eagle to tell everyone within hearing distance that we had found the secret of life."

The Eagle is a pub in Cambridge. With the aid of Abbot Ale, I too have often found the secret of life there. It was in March 1953 that Francis Crick, who died last week at the age of 88, had "winged" in there to announce his discovery of life's secret - the molecular structure of DNA. Brilliant, arrogant and tactless, he was 36 years old and for two years had been working in partnership with Watson, a 25-year-old American.

Their specific project was the deciphering of the structure of DNA, a long and apparently boring molecule found in living cells. But their true project was the overthrow of religion. Both, as Watson has explained to me, were militant atheists and they wished, by exposing the material basis of life, to reveal that there was no transcendent trickery involved.

Life was extraordinarily well organised matter, but it was still just matter. The mechanism of its organisation was explained by Darwin, the details were worked out by Gregor Mendel and, finally, by Watson and Crick.

What they found was, on the face of it, staggeringly simple and weirdly topical. The search for the genetic messenger - the material that transmitted characteristics down the generations - had been long and fraught. Neither Darwin nor Mendel had any idea what was involved; indeed, Mendel's discoveries about inheritance in plants were, at first, taken to be a refutation of Darwin.

DNA, first discovered in the late 19th century, had usually been dismissed as a possible candidate precisely because it looked so simple and boring. Life was complex and so it was assumed that the messenger must be something equally complex, like, for example, proteins.

But the molecule unravelled by Watson and Crick simply consisted of four chemical "letters" - ACGT - repeated over and over again in various combinations, three billion times in the case of human DNA. This was topical because it happened at a time when we were just beginning to realise how complexity could arise from simplicity.

Information theory, the foundation of modern computing, had just got under way and the first gigantic computers were crunching numbers in a few very advanced laboratories. Those computers, as well as the tiny super-complex ones we use today, deployed only two digits - 0 and 1 - and yet they proved capable of immensely sophisticated and rapid operations.

The obvious point to make here is that ever since the birth of modern science, when Galileo first looked through a telescope in 1609, we have tended to see life in terms of the dominant machine of the day.

The most exact analogy for the Watson and Crick discovery was the discovery of the circulation of the blood by William Harvey in the 17th century. Suddenly the body looked like a hydraulic system and with the advent of the industrial revolution of the 18th century, and its vast lifelike machines, the possibility that we were a similar system of pulleys, pumps, tubes, levers, camshafts, fuel and waste was born.

Yet vitalism - the belief that there is something special about the stuff of life - persisted in the minds of most people. This was partly because, amazing as these new machines were, they displayed none of the strange autonomy and complexity of living things. But it was also because of the human brain. It was one thing to see animals as machines, as Descartes had, but quite another to see ourselves in the same way. We were self-conscious, reflective and apparently possessed of free will; how could such a creature emerge from ordinary matter? Descartes said that unlike animals we had a soul which, weirdly, he located in the pineal gland in the brain.

The question of how human consciousness arises from matter, in spite of a deluge of propaganda to the contrary, has not actually been answered. We still have no idea whatsoever how matter becomes conscious. We are not even sure what the question means. Yet the model of the computer convinced many that it was, in principle, answerable. Both DNA and the computer's binary code showed that layers of ever greater complexity could be constructed from the simplest elements.

The power of this idea led to a new scientistic triumphalism that is still with us. Crick, for example, produced a strange book in 1994 called The Astonishing Hypothesis. What, he said, was astonishing was that identity and free will are nothing more than "a vast assembly of nerve cells". Why such a blank statement of an ancient scientific orthodoxy should be astounding to anybody was never explained. In addition, we have had the hard scientistic propaganda of Stephen Hawking and Richard Dawkins. The latter's "selfish gene" hypothesis turns the human being into a mere gene- replicating machine. Such strange fetishisation of the gene has proved to be one of the most bizarre and implausible post- Christian cults.

Meanwhile, James Watson, one of the least pleasant individuals with whom I have ever had dealings, has travelled the conferences of the world making increasingly shocking statements based on his personal creed of scientism. I once asked him: if we found the gene for homosexuality and removed it from the human gene pool, what would be the impact on society? He thought for a moment, then replied, "Less ballet."

Scientistic triumphalism has now begun to look distinctly tattered. The Theory of Everything that the physicists promised us in the early 1990s seems more distant than ever. Indeed, it is widely accepted, as some of us pointed out at the time, to be logically impossible.

The attempt to create artificial intelligence - the reverse engineering of the theory that the human brain was like a computer - has failed miserably. The saner experimenters in this field have now concluded that the one thing the brain is nothing like is a computer.

In genetics and molecular biology - the offspring of the unravelling of DNA - the situation has become even more problematic. The simplicity of the workings of DNA was largely illusory. Even though it now seems that humans have only 30,000 genes, far fewer than originally thought, the interactions of these genes are phenomenally complex.

The American geneticist Craig Venter told me that we could not have designed this system and neither could evolution. Francis Collins, meanwhile, head of the American human genome project, is a born-again Christian. Despite the best efforts of Watson and Crick, God seemed to have re- entered through the back door of genetics. Almost all the claims for the discovery of "the gene for" homosexuality, alcoholism, indeed almost any human trait other than strictly single-gene disorders, have been quietly withdrawn.

Furthermore, the DNA-inspired attempt to locate human nature solely in nature rather than in nurture has also run into trouble. This pendulum swings back and forth. In the early 20th century the conviction that nature was all led to mass sterilisations of the genetically "unfit" in the United States and the tough advocacy of eugenics by, among others, Winston Churchill over here. Nazism discredited this belief and led to an equally extreme conviction that there was no such thing as human nature and that we were solely products of our environment. The neo-Darwinism that emerged in the wake of DNA has again sent the pendulum swinging back towards nature.

The truth is that we still don't know. The statistical methods that aspire to disentangle nature from nurture in, for example, intelligence and homosexuality are riddled with uncertainty. In the case of intelligence, we don't know what it is and we don't know how to measure it. IQ tests have proved hopelessly compromised by their cultural and historical settings. And even an apparently simple yes-no question such as "Are you gay?" leads to further confusions.

If, for example, homosexuality is 50% heritable, then the identical twin of a gay man is as likely to be straight as gay. Why? Crick was a great scientist who was deluded about the power of science. He was led astray by his justifiable awe and enthusiasm for the simplicity and beauty of the molecule that he and Watson had deciphered. They had not found the secret of life because there is no such secret. A far greater mind than any that I have so far mentioned saw this with devastating clarity, not long before the double helix was exposed to the world.

"We feel," wrote Ludwig Wittgenstein, "that even if all possible scientific questions be answered, the problems of life have still not been touched at all. Of course, there is then no question left, and just this is the answer. The solution of the problem of life is seen in the vanishing of the problem."

6.Gene therapy pioneer W.F. Anderson arrested on molest charges

LOS ANGELES Internationally prominent gene therapy researcher Dr. William French Anderson has been arrested. He's charged with sexually molesting a girl over a four-year period.

The 67-year-old scientist was arrested at his suburban Los Angeles home.

The county district attorney's office says he's charged with six felony counts of assault. It accuses Anderson, who was the girl's karate coach,
of abusing her at his home from 1997 to 2001.

Anderson, director of the Gene Therapy Labs at the University of Southern California's Keck School of Medicine, has been put on administrative leave.

He's being held in lieu of six (m) million dollars' bail. Arraignment is set for Tuesday in Pasadena.

Anderson led a team that performed the first approved human gene therapy trial in 1990. The therapy has had mixed results.

Associated Press

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