June 2, 2008

Prozac: this wonder drug could seriously damage your health

ICSPP thanks The Bulletin, Brussels’ newsweekly in English, for their kind permission to reprint this article which appeared in their June 5, 1997 issue. 
Warning: this wonder drug could seriously damage your health 
Woke up this morning feelin’ so blue. Took an antidepressant. But what’ll it do?
Thousands of people are being prescribed Prozac and other so-called wonder drugs to stop them feeling depressed. Do they risk doing themselves more harm than good?
Clare Thomson reports.
"I’m not mad " says Frank van Meerendonk, a former English teacher who is now unemployed and on sickness benefit. He runs the Benelux section of Prozac Survivors Support Group (PSSG, founded in the United States in 1990. Its members all claim to have suffered serious adverse reactions to the so-called miracle drug. Sitting in the lounge of his red-brick home in Oisterwijk, near Tilburg in the Netherlands, the Dutchman is calm and lucid, despite evident difficulty concentrating for long periods. "I don’t want anyone taking the drug to panic," he insists. "I’m not against Prozac or biological psychiatry, but I want people to know the other side of the story."
Van Meerendonk was prescribed Prozac in 1990 by a psychiatrist: he was not suffering from depression, but dizziness, fatigue, tinnitus and hearing loss, after severe flu. "I stopped taking it after my head began to feel strange and my muscles started twitching," he recalls. His old symptoms persisted, despite visits to specialists and an ear operation.
A year later, his family doctor prescribed Prozac for "masked depression", assuring him that any apparent side effects were "all in the mind". But after five days on the drug, Van Meerendonk was a physical wreck. "I felt as if a magnet were pulling the back of my head. There were electrical surges rising through my body. The tinnitus got much worse. I was terrified."
He recalls lying in bed, sweating and hallucinating. Even after his doctor took him off the drug, the symptoms persisted. "It appeared to have caused a huge chemical imbalance," says Van Meerendonk. He was referred to a psychiatric ward. "They wanted to give me medication, including Prozac. I refused. They said I was a hypochondriac, that Prozac couldn’t have done this."
Desperate, he looked elsewhere for help, finally finding a doctor of Chinese medicine at Utrecht University Hospital, who continues to treat him with acupuncture. He has partly recovered, but still suffers from muscle twitching and tinnitus.
"I phoned the Dutch drug authority many times to complain but they weren’t interested," says Van Meerendonk. "Everyone said that Prozac was harmless."
Convinced that the drug was to blame for his ailments, he began collecting information about it. He found out about serotonin, a compound involved in the transmission of nerve impulses. Low levels of the compound, which is thought to influence mood, have been found in the brains of people who have committed suicide: some scientists believe that "selective serotonin reuptake inhibitors" (SSRIs),of which Prozac is one, can alleviate depression by raising the serotonin level.
But problems can occur if receptors in the brain stem and spinal chord are over-stimulated. Sufferers experience fever, chills, muscle spasms, agitation and confusion, dubbed "serotonin syndrome".
Prozac is made by US drug company Eli Lilly. The company’s official line is that serotonin syndrome can occur when Prozac is used with other antidepressants. "You don’t get this syndrome with the recommended twenty milligram per day Prozac pill," says Marc Czarka, director of pharmaceutical affairs for Eli Lilly Benelux.
"Van Meerendonk is among the thirty percent of patients who don’t respond to Prozac," he adds. "People who have had psychiatric diseases often have a distorted view of their symptomology. These illnesses change their perception of reality."  
Van Meerendonk and others argue that their deterioration was sudden and happened after taking Prozac. "Eli Lilly doesn’t listen to patients," claims Van Meerendonk. "If you’re satisfied with Prozac, they say it’s because the drug is effective. If not, they say it’s because of your underlying disease." Van Meerendonk is certainly not alone: the US Food and Drug Administration (FDA) has received a record number of complaints about the drug: 35,000 by 1996.
In 1995, Prozac accounted for 1 billion BF of the 70 billion BF spent on medication by Inami, Belgium’s national health insurance group. It is the sixth best-selling drug in Belgium, where Eli Lilly has a research laboratory (in Louvain-la-Neuve) that is responsible for a sixth of its drug development work. This country was the first to authorise the drug, in 1986, a year before FDA gave it the US go-ahead.
Yet things aren’t all going Lilly Benelux’s way. Recent developments in this country include: 
  • fears of over-prescription were raised in the federal Parliament in March; o a Belgian doctor is collecting anecdotal evidence about the drug’s side-effects;
  • a Flemish group set up last year, Patients’ Representation in Mental Health (PRMH), is questioning the safety of Prozac and other psychiatric drugs;
  • later this year, Van Meerendonk will testify in a murder trial involving a Dutch naval mechanic who last year bludgeoned his mother to death with a hammer. He says Prozac changed his personality. It is the first Benelux case in which the defense will argue that the drug can cause violent behaviour. The "Prozac defense" has been used nearly 70 times in the United States, but with little success.
Czarka insists that the drug is safe. "We’re far ahead in neuro-science," he says, pacing his office and bombarding me with scientific documents. "We’re researching drugs for Parkinson’s disease, for Alzheimer’s, for osteoporosis."
Last year, the company wrote to doctors condemning a September 1996 Paris-Match article that criticised Prozac and referred to the Wesbecker trial in the US (see box). "No one has won a case against Lilly involving Prozac," says Czarka. Despite such confidence, the company is quick to attack anyone and anything that questions the drug’s safety.
The letter to doctors dismissed the Paris-Match article as unscientific and insisted that Prozac, which had up to then been taken by 21 million people world-wide (that figure is now 25 million) is safe. It said that clinical tests with over 30,000 patients prove that the drug reduces aggression and suicidal tendencies.
One of the letters arrived on the desk of Dr. Robert Bourgignon, who runs Securimed, a small company on Avenue Louise that provides doctors with information about drugs. He sent questionnaires to doctors, inviting them to note their patients’ reactions to Prozac.
Eighty responded and reported reactions that included suicidal tendencies and violence.
Lilly has consistently denied a causal link between Prozac and suicidal tendencies. The company claims that the drug has fewer side effects than other antidepressants (for example, it causes less drowsiness), that it is safe because there is no risk of overdosing (SSRIs are less toxic than earlier antidepressants and are absorbed more slowly) and because it has been authorised by national regulatory bodies like the FDA.
"Prozac is a scientific advance," says Bourgignon. "Many people have benefited from it, but some have had bad reactions. I’m worried because the number of people taking it has risen tenfold since 1990 and more and more side-effects, including sexual dysfunction, hallucination and psychosis, are beginning to emerge."
In March [1997], Lilly took Bourgignon to court, accusing him of conducting a non-scientific survey that was commercially damaging to Lilly. Lilly lost the case, but has appealed. The verdict is due in September [1997].
The company has also received adverse publicity from Van Meerendonk, who bases his information on a substantial library of books, articles, videos, documents and scientific papers about Prozac and its manufacturers. Last year, Lilly accused him and the Benelux PSSG of being "pseudonyms for the Church of Scientology".
The Church of Scientology, which opposes all psychiatric drugs, offered to support the founders of the US PSSG after its members had experienced adverse reactions to Prozac. Since then, PSSG groups world-wide have disassociated themselves from the sect.
"I’m convinced Lilly uses the scientology ruse to deflect criticism," says Van Meerendonk, who is backed on this issue by writers and commentators. Van Meerendonk took Lilly to court for linking him with scientology. "I was convinced that I’d win and didn’t prepare a defence."
He lost. The judge said it was understandable that Lilly had connected him with the Church because of the early links between scientology and the PSSG, and because Van Meerendonk had not personally disassociated himself from the sect. Van Meerendonk is preparing an appeal.
"Van Meerendonk’s story is no reason to ban Prozac," Czarka insists. Yet Van Meerendonk is not asking for a ban. "I realise how bad depression can be and that psychotherapy doesn’t always help," he says. "But I’m convinced that many people have been wrongly prescribed Prozac: when they’re in mourning, want to give up smoking or drinking, want to lose weight or have been mugged. What these people really need is empathy and support."
Last year, Rose Chambers, an Englishwoman living in Belgium, was prescribed another SSRI, Seroxat. "I wasn’t depressed, just feeling a bit low," she says. "My doctor asked if I was tired and had trouble getting up some mornings. When I said yes, he told me that this drug would make me feel better. It didn’t. I became feverish and my head felt as if it was going to explode. He blamed it on a virus, but I’m sure it was the drug, so I stopped taking it."
"Nobody knows the long-term side-effects of Prozac or other SSRIs," argues Van Meerendonk. "For years, doctors denied that there were problems with Valium and benzodiazepines. Now we know that they can be addictive. Prozac should be prescribed only when absolutely necessary."
When Ecolo politician Thierry Detienne raised the issue of Prozac over-prescription in Parliament in March, he referred to a 1994 study by David Healy, one of Lilly’s consultants, which concluded that antidepressants, including Prozac, could induce suicidal tendencies.
Health Minister Marcel Colla said that there was no reason to doubt the drug’s safety, since regulatory bodies throughout the EU have authorised it. But he admitted that doctors need objective information, that they should take possible side-effects into account and prescribe with care.
The Prozac controversy in the US was fuelled by two books written by psychiatrists. In Listening to Prozac (1993), Peter Kramer claims that the drug transformed the personality of some of his patients, making them feel "better than normal" and that if you introduced it into mains water, everyone who drank it would be happier.
Kramer’s book boosted Prozac sales. Talking Back to Prozac (1994), by Peter Breggin, had the reverse effect. Breggin’s criticisms of Lilly are devastating. He researched clinical trials of the drug before it was marketed and concluded that they were inadequate because:
  • they were too short (four to six weeks);
  • they did not include children, the elderly or the suicidal;
  • many patients dropped out following adverse reactions;
  • patients were given sedatives to reduce Prozac’s stimulating effect;
  • fewer than one in three trials showed Prozac to be effective; even these suggested that it was no more effective than previous antidepressants.
"The FDA supports the drug industry and its needs at the expense of the public and the consumer," writes Breggin, adding that an early in-house FDA report, ignored by the organisation’s top decision-makers, described Prozac as a stimulant that could, in a few cases, over-stimulate the central nervous system and worsen depression.
Lilly has dismissed Breggin’s criticisms. "We have no evidence that anything Kramer or Breggin says is true," Czarka insists. But Lilly did not sue either author and neither has had to retract any of his conclusions.
According to Van Meerendonk, giant pharmaceutical companies like Lilly persuade people that clinical depression is a physical illness that can be cured by medication. "Lilly gave ‘educational’ grants to organise American National Depression Screening Day in 1994," he claims. "They even orchestrated an edition of The Oprah Winfrey Show in which participants spoke glowingly of Prozac: some said it had saved their lives. What they didn’t reveal was that Lilly’s PR company, Burson-Marsteller, was behind the programme, hand-picking members of the audience and flying them in from around the country."
Czarka concedes that Lilly funds the American Psychiatric Association and that, with other pharmaceutical companies it sponsors and helped create the Belgian League of Depression in 1995. "It’s useful for us because, unlike American law European law does not allow us to talk directly to potential patients," says Czarka. "The league does it for us.
"We’re not marketing depression. We’re providing funds to fight a disease that can be deadly. It shows our dedication to patients. That’s why we fund research and studies throughout Belgium."
Psychiatric patients are waking up to the possibility of information manipulation. In terms of patient representation Belgium lags behind the Netherlands, but the Flemish group PRMH is lobbying Parliament to make people more aware of the power wielded by pharmaceutical companies.
Founder Jan Vanhaelen was prescribed an anti-psychotic drug for back pain. "I developed severe depression, was given a series of antidepressants, tranquillisers and sleeping pills and ended up in a psychiatric hospital for three months. I had to take a year off work.
"Doctors should know more about the drugs they prescribe," he says, adding that Belgian doctors prescribe twice the amount of psychiatric drugs per person as their Dutch counterparts. "Most psychiatrists know little apart from the promotional material companies send them. Several years later, they make their own observations about a drug’s efficacy. Meanwhile, patients suffer.
"I’ve talked to around a hundred patients who’ve had Prozac," Vanhaelen continues. "Ten percent say that it helped them enormously, ten percent said they reacted badly and the rest didn’t respond to the drug at all."
Many doctors admit that Prozac is not as effective as they had at first believed. Dr Guido Peeters, a Flemish psychiatrist who works with the Community Help Service, suggests why. "It’s well known in medical circles that you are more likely to prescribe a drug when it’s new. There’s a placebo effect that produces hope in the scientific community and among patients. Prozac seemed to work well in the beginning and it can be useful, although it’s probably over-prescribed. It’s easy for doctors to hand out pills and many patients prefer to go for the ‘quick-fix’ pill rather than discuss their problems.
"It is vital that doctors who prescribe antidepressants monitor their patients closely. Serious side-effects should be reported promptly to the Government. There’s been a lot of talk about Prozac, partly because of the debate about whether all psychiatric problems can be explained by biochemical mechanisms. There are arguments on both sides. We try to judge the value of research."
Eli Lilly insists that depression is a biochemical disease. "Depression kills" says Czarka. "You shouldn’t put people off medication when it can save their lives."
For Van Meerendonk, this is a reductionist view. "It’s naive to say that a malfunction in the neurotransmitter system is the main cause of depression and that the illness can be treated by drugs. It’s also convenient for employers, families and society to blame individual failings on biochemistry, rather than confront social problems like unemployment."
The Government is debating whether to follow the example of the US and authorise Prozac to treat other "biochemical" disorders, including obsessive compulsive disorders like bulimia. A decision is expected this year. If they give it the green light, sales of the drug are likely to soar.
Rough justice?  
Joseph Wesbecker had been taking Prozac when he walked into his workplace, an Indianapolis printing plant, in September 1989, shot dead eight colleagues, wounded 12 and killed himself. Survivors and relatives of the dead took Lilly to court in 1994. They claimed that Wesbecker’s violence was due to Prozac. The jury found that Prozac was not at fault.
Two years later, media pressure forced Lilly to admit that it had reached an out of court settlement with the plaintiffs. In return for an undisclosed – and reputedly large – sum the plaintiff’s and their lawyer agreed not to bring potentially damaging evidence about another Lilly drug, Oraflex, into the trial. The story is related in The Power to Harm: Mind, Medicine and Murder on Trial (Viking, 1996), by British journalist and writer John Cornwell.
In 1985, writes Cornwell, Lilly pleaded guilty to charges brought by the US Justice Department for failing to report fatal reactions in Britain to Oraflex, an anti-inflammatory drug for arthritis relief. The company, whose global sales total $7.3 billion (around 255 billion BF) – $2.4 billion from Prozac alone – was fined $25,000 (around 875,000 BF). Lilly had been forced to settle hundreds of civil compensation claims and, says Cornwell, urgently needed a best-selling drug.
The Wesbecker verdict boosted Prozac sales in the US even though, as Cornwell points out, "Prozac had failed to help the sort of patient it was designed for."