Horrifying legacy of the 'celebrity sedative'
marketed without tests
Sunday Express, October 29, 2000
by Lucy Johnston and Jonathan Calvert
MILLIONS of patients have been given a leading tranquilliser without being told of its potentially catastrophic long-term effects.
And the manufacturer of Ativan – which is claimed to be linked with damage to the brain and nervous system – will this week face accusations that it should have known about its addictive dangers.
The drug – produced by the American pharmaceutical giant Wyeth – has been prescribed since the Seventies as a wonder cure for anxiety.
Wyeth has always insisted that it is harmless, but in the late Eighties it was forced to advise patients against long-term use of the drug – by then known as Lorazepam – because of health risks.
Now long-term users, such as Mike Burkinshaw 56, who took Ativan for 18 years and is disabled and in constant pain, say they should have been told earlier.
The former British Telecom engineer was prescribed Ativan at 34 for feelings of aggression. Just months later he suffered a violent seizure. He developed memory problems and soon lost his job.
Today he is in constant agony walks with sticks, and suffers vision and memory loss.
Barry Haslam, 58, also claims he became addicted to Ativan following a nervous breakdown. He suffered violent mood swings and memory loss so severe that he has "lost" 10 years of his life.
"It is like having a chemical lobotomy" said Mr Haslam, from Oldham, Greater Manchester who doesn't remember his children growing up and still suffers ill-health.
Today the Sunday Express can reveal that two of Wyeth's own medical directors had grave concerns about the long-term use of the drug.
In documents seen by this newspaper they claim the company should have been aware of the potential dangers.
They believe detailed research ought to have been carried out before so many people became dependent on the drug.
One of the medical directors is Dr Thomas Harry who masterminded the crucial clinical trials for the drug at the company's research centre in Taplow, Bucks. The UK was the launchpad for licensing Ativan around the world.
In his statement he says he was never asked to undertake trials to find out whether it was safe to prescribe the drug for several months or more.
He believes one reason why long-term trials were not carried out "was that there was nothing to be gained by them, but everything to lose in the sense we could be courting disaster".
Ativan was launched in 1972 and became one of the company's most successful products with sales of £36million a year in the early Eighties.
High profile users of this and similar drugs have included the late TV presenter Paula Yates, actresses Liz Taylor and Judy Garland, singers Marc Almond and Liza Minnelli and comedian Freddie Starr.
Dr Harry, a former psychiatrist, says the drugs were designed to be taken for only a few weeks, and if he had been told it was to be used long term, he would have queried the instructions over the trials.
"I would have to advise a company that it would not be proper to market the product for a long-term," he said. But he says that for years after they went on sale, the company failed to make it clear that the drugs were not to be taken over a prolonged period.
"The company did not tell doctors, either in data sheets or elsewhere, that Ativan should only be prescribed short-term," he said.
In fact, many people became dependent on the drug for years. Dr Harry says the company could have foreseen this potential danger if they had done more research before Ativan was launched.
He said: "The view of most people in the industry at the time was that there was a high probability that a patient would have difficulties in withdrawing from any drug that acts on the central nervous system.
"The trials were carried out for too short a period of time to reveal the side-effects which, we now know result from prolonged administration of this drug."
He says no proper long-term research work was done on dependency until after 1986 – 14 years after the drug had gone on sale – despite the fact, he says, that "there was a growing awareness of the dependency problem from, at the latest, the late 1970s".
He also alleges that Wyeth failed to pursue research which had earlier indicated that the drug could cause seizures, memory loss and tremors.
In separate documents, Dr Deepak Malhotra, a former medical director of Wyeth Australia, also claims that Wyeth failed to warn the public about the dangers of Ativan.
The company is obliged to highlight potential health risks in its data sheets distributed as a warning to doctors.
In the UK, the first mention made of "possible dependence problems," was in 1979. By 1983 the company admitted that prolonged use may "occasionally" result in "some psychological dependence with withdrawal symptoms on sudden discontinuation".
But it was not until 1988, after pressure from the public and medical professionals, that the Government forced Wyeth to issue strict guidelines. These stipulated that the drug should not be taken for more than four weeks unless a specialist gave exceptional reasons for doing so.
By then the drug had lost its patent and was being produced by a series of manufacturers under the new name Lorazepam. It is still known by that name today and has carried the warning since 1988.
Thousands of people now claim to have been harmed by Ativan, which belongs to a group of tranquillisers known as benzodiazepines. According to Government figures they kill more people than heroin, Ecstasy and cocaine combined.
It is believed that if they are used over a long period, the tranquillisers disrupt electrical pathways in the brain, causing damage to the central nervous system.
This is alleged to have caused a number of symptoms including depression, epileptic fits, stomach disorders, irregular blood pressure, hallucinations, loss of vision or memory, insomnia and muscle problems.
The evidence against Ativan and other tranquillisers will be heard at an international conference in Croydon this week. Scientists, MPs and victims will be calling for a public inquiry into how the drug was given approval.
The company said on Friday that the drug is now only prescribed for short-term use because it is not desirable that people should become dependent.
It does not accept that the drug is – or ever was – harmful and says its knowledge of the dependency problem developed over a number of years.
In a statement it said: "While Wyeth sympathises with those patients whose illnesses have clearly caused them considerable distress and difficulties in life, the company firmly believes that there is no medical or scientific basis to substantiate allegations in this regard made against benzodiazepine products."
A joint legal action against the manufacturers involving thousands of long-term users, collapsed in 1994 after the Legal Aid Board ended its funding for their case. Now 35 of them are taking their cases to the European Court of Human Rights, claiming they were denied a trial.
Reg Peart, ex-atomic scientist and national co-ordinator of Victims of Tranquillisers, said: "This is the biggest medical scandal of the 20th century perpetuated by drug companies and resulting in a catalogue of misprescriptions, misdiagnosis and suffering."
Pam Armstrong, co-founder of the Liverpool-based Council for Involuntary Tranquilliser Addiction, added: "The legacy goes on. Thousands have been permanently damaged and we are picking up the pieces. Even today the addictive potential of these drugs is not being recognised.
"This is a drastically under-estimated problem and even doctors don't realise how bad it is."
See Sunday Express Report, May 13, 2001
See Sunday Express Report, July 22, 2001
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