Unethical Pharma Marketing – Why It Means Life Or Death
Does anyone remember Thorazine? It was an antipsychotic given to mentally ill people, often in institutions, that was so sedating, it gave rise to the term “Thorazine shuffle.” Ads for Thorazine in medical journals, before drugs were advertised directly to patients, showed Aunt Hattie in a hospital gown, zoned out but causing no trouble to herself or anyone else. No wonder Thorazine and related drugs Haldol, Mellaril and Stelazine were called chemical straitjackets.
But Thorazine and similar drugs became close to obsolete in 1993 when a second generation of antipsychotics which included Risperdal, Zyprexa, Seroquel, Geodon and Abilify came online. Called “atypical” antipsychotics, the drugs seemed to have fewer side effects than their predecessors like dry mouth, constipation and the stigmatizing and permanent facial tics known as TD or tardive dyskinesia. (In actuality, they were similar.) More importantly, the drugs were obscenely expensive: 100 tablets of Seroquel cost as much as $2,000, Zyprexa, $1,680 and Abilify $1,644.
One drug that is a close cousin of Thorazine, Abilify, is currently the top-selling of all prescription drugs in the U.S. marketed as a supplement to antidepressant drugs, reports the Daily Beast. Not only is it amazing that an antipsychotic is outselling all other drugs, no one even knows how it works to relieve depression, writes Jay Michaelson. The standardized United States Product Insert says Abilify’s method of action is “unknown” but it likely “balances” brain’s neurotransmitters. But critics say antipsychotics don’t treat anything at all, but zone people out and produce oblivion. They also say there is a concerning rise in the prescription of antipsychotics for routine complaints like insomnia.
They are right. With new names and prices and despite their unknown methods of action, Pharma marketers have devised ways to market drugs like Abilify to the whole population, not just people with severe mental illness. Only one percent of the population, after all, has schizophrenia and only 2.5 percent has bipolar disorder. Thanks to these marketing ploys, Risperdal was the seventh best-selling drug in the world until it went off patent and Abilify currently rules.
Here are some of the ways Big Pharma made antipsychotics everyday drugs.
Everyone has heard of “mission creep.” In the pharmaceutical world, approval creep means getting the FDA to approve a drug for one thing and pushing a lot of other drug approvals through on the coattails of the first one. Though the atypical antipsychotics were originally drugs for schizophrenia, soon there was a dazzling array of new uses.
Seroquel was first approved in 1997 for schizophrenia but subsequently approved for bipolar disorder, psychiatric conditions in children and finally as an add-on drug for depression like Abilify. The depression “market” is so huge, Seroquel’s last approval allowed the former schizophrenia drug to make $5.3 billion a year before it went off patent. But before the add-on approval, AstraZeneca, which makes Seroquel, ran a sleazy campaign to convince depressed people they were really “bipolar.” Ads showed an enraged woman screaming into the phone, her face contorted, her teeth clenched. Is this you, asked the ads? Your depression may really be bipolar disorder, warned the ad.
Sometimes the indication creep is under the radar. After heated FDA hearings in 2009 about extending Zyprexa, Seroquel and Geodon uses for kids–Pfizer and AstraZeneca slides showed that kids died in clinical trials–the uses were added by the FDA but never announced. They were slipped into the record right before Christmas, when no news breaks, and recorded as “label changes.” Sneaky.
And there is another “creep” which is also under the radar: “warning creep.” As atypical antipsychotics have gone into wide use in the population, more risks have surfaced. Labels now warn against death-associated risks in the elderly, children and people with depression but you have to really read the fine print. (Atypical antipsychotics are so dangerous in the elderly with dementia, at least 15,000 die in nursing homes from them each year, charged FDA drug reviewer David Graham in congressional testimony.) The Seroquel label now warns against cardiovascular risks, which the FDA denied until the drug was almost off patent.
Perhaps no drugs but ADHD medications have been so widely used and often abused in children as atypical antipsychotics. Atypical antipsychotics are known to “improve” behavior in problem children across a broad range of diagnoses but at a huge price: A National Institute of Mental Health study of 119 children ages 8 to 19 found Risperdal and Zyprexa caused such obesity a safety panel ordered the children off the drugs.