Last month, when pressed by doctors and parents alike to disclose clinical trial information, manufacturers of Paxil, Zoloft, Effexor and Lexapro refused to do so. Claiming that these studies are "trade secrets," these drug companies still maintain their view that antidepressant drugs are safe for children under 18 to use.
According to the National Institutes of Health, one in eight adolescents may suffer from depression. Furthermore, suicide is the third leading cause of death among young people ages 15 - 24, and it is the sixth leading cause of death among children ages 5 - 14. And the numbers keep growing.
Even more disturbing is the fact that the medical cure for this problem rests on a shaky foundation -- the data collected from clinical trials on these drugs may not seem so peachy as the advertisements. Also, no law requires medication companies to release this data. It is given a positive test by both the company and the FDA and then sent off to the manufacturers. As long as there exists a positive test, the negative tests are often overlooked and called "skewed data collection," according to the British periodical The Guardian.
Clinical depression is a diagnosed illness that until recently was not understood to be a possible chemical alteration in the cerebrum. There are seven types of depression, all which are caused by the imbalances in the brain's level of serotonin, one of the key mood regulators in the human brain. A low level of serotonin leads to depression, and irregular, fluctuating serotonin levels contribute to bipolar disorders or manic depression. While there may be other biological and social factors when trying to pinpoint the causes of depression, serotonin levels are the final indication of a person's mental health.
Concern over the legitimacy of antidepressants as a cure for children has been raised after last year's warning by British administrators that the drugs may trigger thoughts of suicide and self-inflicted pain. Although a medical advisory panel of the FDA was scheduled two weeks ago, the agency's full U.S. analysis of the data is not likely to be completed until late August. This means there will be no alert on the public's prescriptions.
Guardian investigators uncovered another significant piece of news from GlaxoSmithKline, a drug giant in Europe. A position paper dated October of 1998 shows that managers at that company were troubled at the commercial distribution of two clinical trials in which the drug Seroxat -- the equivalent of Paxil or Zoloft -- was given to children and adolescents with major depression.
The results of both trials, known as protocols 329 and 377, showed that the Seroxat was no better than a placebo, a "pseudo' pill, in curing the children's depression.
Forced by both the government and the public to release data on these two trials, Glaxo submitted the full reports to BBC News. In a news release, they stated that since the drug had a good number of positive results in the protocol 329, the consequent manufacturing was still carried out. After careful evaluation, the British government decided to ban all drugs except Prozac for children less than 18 years of age.
On the other side of the coast, however, the public and the government do not have the luxury of demanding such information from drug companies. The news we do have is that besides Prozac, no other antidepressant drug has been tested on children under 18. According to The Washington Post, doctors writing prescriptions do not have approved labeling to guide them and must rely on their own judgment and the available scientific knowledge, even though some pertinent information is not being disclosed. And being 18 years old is pretty close to 19, 20, 21 or 22.
Antidepressant medication is also chemically addictive: When the reports in the U.K were released, British regulators warned people who were currently taking the medication not to stop because of the harmful side effects and sudden withdrawal symptoms.
The National Institutes of Health is currently performing other studies on these drugs. Because of the adamant nature of the drug companies, though, the NIH will primarily focus on adolescents and young adults, so as to only conduct experiments in which the industry is mutually exclusive of psychology.
The question remains: Is conventional psychiatry biased towards its well-known financial ties to the pharmaceutical industry?
"If the companies wanted to publish negative studies they could, but companies don't like to publish negative studies," said Russell Katz, director of the neuropharmacology division at the FDA, which has access to all the data, in a recent interview with the Post. "It's amusing so many people are making pronouncements about the data -- scientists and physicians -- ... without seeing the data."
Supria Ranade is a sophomore.
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