Anti-depressants becoming more of a problem than a remedy for patients

Charles Medawar, Specialist on Medical Policy and Drug Safety, Project Syndicate

The widespread prescription of drugs for troubled minds has always ended badly, right back to the days of opiates and cocaine, up through bromides, barbiturates, and tranquilizers: all proved to be highly addictive drugs, but only after years of denial did doctors admit that this was so. Now anti-depressants--global brands with household names--are the problem. The past decade has seen a three-fold increase in prescriptions. In England, prescriptions of anti-depressants now match Valium at its peak in 1979.

It is now clear that today's anti-depressants are not the wonder drugs they were touted as being. The sometimes intolerable withdrawal symptoms that can make it difficult and hazardous to stop taking anti-depressants also expose many users to severe and depressing side effects: substantial weight gain, loss of libido, and mood changes, to name just the most common complaints. Suspicions about such problems--especially about drug-induced suicidal behavior and sensitization to depression--have been rumbling for years, but searching scientific investigations have only just begun.

An important inquiry set up by the United Kingdom's drug regulators in mid-2003 will soon report its findings. They will no doubt be presented mainly as recommendations for small-print changes in the warnings on drug labels and in the instructions for the drug's use. This may help, it but won't address the real issue: how could regulators have allowed this problem to recur after so much bitter experience, and why should they now be allowed to investigate themselves?

On the Richter scale of drug disasters, the looming anti- depressant crisis appears to range between 7 and 11, where thalidomide rates a 10. Time will tell, but the key point is this: the thalidomide disaster of the 1950's and 1960's happened because there was no independent control of drug safety, whereas the anti-depressant crisis has grown under the aegis of an elaborate, expensive, and global regulatory system.

The nub of the anti-depressant crisis is not that these drugs could do so much harm, but that they were allowed to do so when the precedents were so plain. If and when this crisis is ever properly investigated, it will not so much open a can of pharmacological worms, as expose questions about what medicine is and should be.

These underlying issues seem all the more important because the Internet has for several years been groaning with evidence of the crisis to come. The explosive growth of the Internet introduced completely new opportunities for gathering, presenting, and communicating evidence. It broadened and deepened understanding of the problems associated with anti-depressants, giving patients a collective voice, as never before.

Previously, drug safety monitoring relied on occasional adverse reports from health professionals about patients' reaction to medicines. But this crisis revealed these reports' fundamental inadequacies, such that users' experiences with drugs can never credibly be ignored again.

United by the Internet, many thousands of patients from all over the world began to describe experiences with anti-depressant drugs and problems brought on by withdrawal that bore little resemblance to the labels' warnings. The impact of this user intelligence has been profound: in 2003, one pharmaceutical company revised its 2002 estimate of the incidence of withdrawal reactions from 0.2% to 25% (even as the manufacturer of a similar drug continues to claim that it is "not habit forming" at all).

The anti-depressant crisis provides, for the first time, dramatic evidence of the collective value of user reports in understanding drug risk. To be sure, user reports are not "scientific" and most, individually, might seem naove, confused, exaggerated, mistaken, and/or just plain self-absorbed. Yet in this case they provided, collectively, more reliable evidence than that reported in numerous controlled clinical trials.

So, now the question is not so much the value of patients' reports, but the integrity of medical research and the state of science. "Just how tainted has clinical medicine become," asked an editorial in the British medical journal The Lancet in 2002; the answer was "heavily and damagingly so." The duplicity surrounding the marketing of anti-depressant drugs underscores just how corrupt the profession has become.

The crisis now unfolding raises broad issues concerning democracy and science, the relationship between risk and benefit, and the conflict between imperatives of trade and health. But one feature above all others captures the underlying problem: the yawning gap between the words of patients who speak their minds and the terminology of producers, experts, and authorities who mince words.

The 1990's saw "depression" formally redefined as a serotonin- deficiency disease and the scourge of millions--a convenient and seductive view, but deeply simplistic. The term "drug dependence" was also redefined, to propose that loss of personal autonomy could never arise in a therapeutic setting. The ubiquitous term "discontinuation symptoms"--Orwellian newspeak for withdrawal--implied that anti-depressants carried no risk of dependence.

On the contrary, wishful thinking led experts to adduce "discontinuation symptoms" as evidence of the effectiveness of vital remedies. Later, suicides became routinely described as "non-accidental overdoses," and the broad-spectrum term "emotional lability" came into vogue, despite its inability to distinguish between a drug-induced suicide attempt and an outburst of tears.

By contrast, user reports of adverse reactions attempt to describe some human reality, rather than promote images that suit the vested interests involved. In the long run, the anti- depressant crisis thus may prove to be a blessing in disguise, but only if it brings about the transparency and intellectual honesty needed to make the medical profession ultimately accountable to the people it claims to serve.

Charles Medawar is currently a director of a small London- based unit, Social Audit Ltd, mainly funded by the Joseph Rowntree Charitable Trust.