Professional Issues >> Standard of Care

One advertisement on the New York subway can be enough to undo years of careful treatment of mentally ill patients in the care of Ralph Aquila.

Usually, about 400 people walk in every day for medical treatment and job training at Fountain House, where Dr Aquila works in Manhattan's Hell's Kitchen district.

But some patients suddenly stop coming to see him - even after months of regular contact, he says - in response to warnings that their medication, known as atypical antipsychotics, can be harmful for schizophrenics. The adverts are an example of what doctors, companies and independent experts say is a rapidly growing national problem of alarmist and misleading claims by lawyers seeking new clients.

Attorneys use the ads to claim that such products as Eli Lilly's Zyprexa, Johnson & Johnson's Risperdal, and AstraZeneca's Seroquel can cause diabetes and even complications that lead to comas or death.

"It's a pretty touchy kind of thing for people who don't necessarily have the [mental] resources to weigh what's going on. The repercussions can be truly, truly tremendous," says Dr Aquila, who is also a psychiatrist at St Luke's Roosevelt Hospital.

Many observers agree that the adverts are proliferating because of the public's increasing risk aversion. Product withdrawals, demonisation of regulators and alarmist talk of side-effects are drowning out a balanced understanding of important patient benefits, they say.

The television, radio, print and billboard adverts typically include "urgent warnings" and flashing lights behind the drug name - and hold out the prospect of financial compensation for anyone who may have suffered the slightest ill effect.

Plaintiffs' attorneys maintain that their publicity is legal and that the safety concerns are genuine.

"By and large, lawyers who advertise with regard to drugs or products like asbestos are calling attention to the public of very real dangers," says Carlton Carl of the Association of Trial Lawyers of America. Any "over-the-top" adverts were no worse than consumer advertising put out by the drugmakers, he added. But according to a 2003 study by the pro-business US Chamber of Commerce, 38 per cent of doctors reported instances of patients who stopped taking drugs because of lawsuit advertising.

About 44 per cent of pharmacists surveyed reported that a patient had stopped taking a prescribed medication. While drug safety concerns and litigation over pharmaceutical risks have risen since Merck's withdrawal of Vioxx, the real menace, some doctors say, are adverts that target medicines treating schizophrenia, epilepsy, multiple sclerosis and depression - illnesses that can be dangerous for the sufferer, or even the general public, if not managed properly. Advertising by attorneys falls under the authority of the Federal Trade Commission, not the Food and Drug Administration, the US chief medicines regulator.

However, the FTC says it pays little attention because the messages are either protected by a constitutional right to free speech or are the responsibility of state authorities because they are broadcast only locally.

"It rarely crosses our radar," said Thomas Paul, FTC's assistant director of advertising practices. Adverts could warrant scrutiny, he said, if deemed to exaggerate risk far beyond the FDA's intention or to put patients in imminent danger.

But he added: "If it's not false or misleading and the government wants to prohibit it, the government would face extremely high hurdles to do so, and with good reason." Eli Lilly says it has managed to force several plaintiffs' attorneys to drop false or misleading claims from their adverts. But it admits that Zyprexa advertising is so widespread that monitoring all the messages is like searching for "needles in a haystack".

Pfizer says it found one 15-second television spot by a law firm targeting side-effects from Neurontin, an epilepsy drug, that showed a silhouette of a woman looking up at a noose -a blatant and unfair suggestion of a link to suicide, Pfizer says.

"These plaintiffs' lawyers are causing a public health crisis themselves," says Lou Bernstein, Pfizer's assistant general counsel.

"Maybe it's not like yelling 'Fire!' in a crowded theatre, but it's getting close."

Many doctors agree. For the mentally ill, they say, the tone of the advertisements can be just as detrimental to patients as the words: ominous music, flashing words such as "urgent".