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Drugmakers are facing a summer of intense scrutiny over the safety of anti-depressants for children and questions about the suppression of negative research on the lucrative drugs.
The anti-depressant market, particularly for selective serotonin reuptake inhibitors (SSRIs) - of which the most famous is Eli Lilly's Prozac - is big business.
Some $19.5bn worth of anti-depression drugs were sold in 2003, according to IMS Health, up 10 per cent year-on-year. IMS estimates SSRIs and selective norepinephrine reuptake inhibitors (SNRIs) will have $11bn in US sales this year, a rise of 11 per cent.
The industry foresees continuous growth from the 85m patients with depression worldwide, although less than 50 per cent of them meet diagnostic criteria. Just under half of treated patients take themselves off the medicines in the first three months.
The Pharmaceutical Research and Manufacturers Association, an industry lobby group, says depression costs the US economy about $80bn annually from missed work days and associated issues.
It says a high percentage of those with depression do not receive treatment. A subcommittee of the House of Representatives Energy and Commerce Committee plans hearings this month on FDA research and its regulatory position on the safety of anti-depressants' for children.
The panel also wants to review the circumstances this year under which the FDA apparently barred Dr Andrew Mosholder, its investigator, from publicly releasing his conclusion that certain anti-depressants carried an increased risk of suicidal tendencies in minors.
Other legislators, possibly in the Senate, are also interested in probing the FDA's decisions, or lack of them, on anti-depressants used by children. "The point is to get things into the public record, where anyone can access them for future inquiries," says one person close to the Senate.
Meanwhile, pharmaceuticals groups, regulators, doctors, parents and industry critics alike await an independent trial of anti- depressants by Columbia University. Due this summer, the FDA-commissioned study aims to produce a more standardised picture of suicidal and self-harming behaviour in children treated with anti-depressants. The result could prompt US regulators to continue to allow doctors to use the drugs for children, or lead to a ban for those not approved for such use. Only fluoxetine, which is Prozac or its generic equivalent, is approved for minors.
The investigation by Eliot Spitzer, New York attorney-general, also continues. Mr Spitzer has charged Glaxo- SmithKline with "persistent fraud" for allegedly hiding research that reveals dangers of its anti-depressant Paxil in children.
Mr Spitzer has requested documents from Forest Laboratories, maker of Celexa and Lexapro anti-depressants. His investigation could expand to others.
These developments increase the growing scrutiny of anti-depressants, as well as regulators' approval of them. They shine a harsh light on drugmakers' selective use of positive research to promote drugs, despite the heightened potential for suicide-inducing side-effects. They also dig into US regulators' ability to monitor trial data for safety problems.
A study published in 2002 in Progress in Neuro-Psychopharmacology and Biological Psychiatry found that more than 90 per cent of doctors prescribed SSRIs first when treating depression.
SSRIs changed the anti- depression market and how drug companies viewed depression. Once seen as small drugs for a small market, depression drugs have become one of the most lucrative areas for drugmakers, who in turn have reshaped society's views of depression and psychopharmacology (the use of drugs for diseases of the mind).
SSRIs have had a chequered history, but staggering commercial success. Since Prozac's release in the late 1980s, the class of drugs has weathered persistent connections with potential increases in suicidal behaviours.
In 1991, the FDA held hearings into how Prozac could stimulate suicidal ideas. The agency ruled that the evidence did not support such a finding, but recommended further research.
"Once [the FDA] get it in their mind that a drug is safe and effective, they're almost as difficult to convince [otherwise] as the drug companies," says Dr Sidney Wolfe, head of the health watchdog group at Public Citizen.
The industry - and many doctors and scientists - have argued that it is the disease, not the drug, that causes suicidal behaviour in patients.
In March the FDA warned doctors to monitor patients on any of 10 anti-depressants for potential suicidal behaviour. US regulators began reviewing the issue last June after looking at Glaxo's trial data for children taking Paxil.
Prescriptions to children have soared. The FDA says doctors wrote 10m anti-depressant prescriptions for children aged 1 to 17 in 2002. About 20 per cent of those were for Paxil, which was the second-most prescribed anti-depressant for children, even though it was not approved for such use.
In December, UK regulators barred use of anti-depressants in children, except Prozac.
With new anti-depressants on the way, such as Lilly's Cymbalta, the summer could prove pivotal in their use for children and how drugs companies promote them.
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