Healthy Skepticism Library item: 17010

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E
Drugging Kids for Profit
Portfolio.com 2009 Jan 4
http://www.portfolio.com/industry-news/health-care/2010/01/04/drugging-kids-for-profit/index1.html

Abstract:

As uses for antipsychotic drugs multiply, these powerful substances with strong side effects are being used to treat kids more and more often.

Full text:

If elderly people with dementia are so vulnerable to the risks posed by antipsychotics, why are so many nursing-home residents regularly prescribed the medications?

The answer can be found in a controversy with its roots in aggressive marketing and lackadaisical supervision. Known in the medical community as atypical antipsychotics, this group of drugs was originally approved by the Food and Drug Administration to treat adults suffering from schizophrenia. They go by snazzy names such as Zyprexa, Geodon, Abilify, and Seroquel. Later, regulators allowed doctors to prescribe them for treating bipolar disorder. Over the past decade, the pills have become a veritable goldmine; in 2008 alone, sales in the U.S. reached $14.6 billion.

But critics say those big sales are actually due, in part, to an epidemic of off-label marketing, which is promoting a drug for unapproved uses, although doctors are free to write a prescription regardless. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters. This was particularly troubling, given that the drugs can cause diabetes and weight gain, side effects that prompted thousands of lawsuits claiming that drugmakers tried to hide evidence of these problems.

Another side effect is even more disturbing-unnecessary deaths among elderly patients, who shouldn’t receive these medicines if they suffer from dementia. A recent study found that more than 140,000 dementia patients in the U.K. are given these meds needlessly and some 1,800 elderly deaths are linked each year to overprescribing. Moreover, only 20 percent of 180,000 dementia patients received any benefit.

In general, people taking antipsychotics are nearly twice as likely to have a stroke compared with those not on the meds, according to a study in the British Medical Journal. And the risk is higher-about 3.5 times-for those with dementia, which means doctors should only prescribe the pills as a last resort.

Of course, there are people in nursing homes with behavioral problems such as agitation and psychotic episodes. Yet reports periodically emerge that chronically understaffed nursing homes all too often dispense antipsychotics in order to subdue patients. A recent investigation by the Chicago Tribune, for instance, found that nursing-home residents in Illinois are drugged without their consent or without a legitimate psychiatric diagnosis that would justify treatment.

“Companies want to sell drugs, doctors prescribe the drugs most heavily marketed, nursing homes need doctors to legitimize their actions, and nurses are probably overworked and want doctors to medicate people so they’re more malleable,” says Robert Rosenheck, a Yale University professor of psychiatry and epidemiology and director of the Division of Mental Health Services and Outcomes Research.

“The participants start to gain, but the general public and the patients may not be better off. There’s evidence the drugs aren’t always effective, may be harmful, and can cost a good deal of money, but there’s nothing we can do about it, because we’re committed to the principal that doctors should be able to choose whatever treatments are best for their patients,” he continues. “About 60 percent are prescribed off label for non-psychiatric conditions for which there’s no FDA approval.”

Off-label marketing has led to huge fines. Last year, Pfizer paid a $2.3 billion fine to settle civil and criminal investigations into fraudulent marketing of several drugs, including Geodon. Eli Lilly, which markets Zyprexa, paid a $1.4 billion fine and pled guilty to a misdemeanor for promoting its drug to the elderly with dementia, even though the pill was never approved for that use. And AstraZeneca reached a tentative $520 million deal to settle probes into off-label marketing, among other charges.

But drugmakers weren’t the only ones tagged. Omnicare, a big pharmacy that specializes in providing drugs to nursing homes, agreed to pay $98 million to settle charges of soliciting or paying kickbacks. One example-payments were made in exchange for recommending Johnson & Johnson’s Risperdal antipsychotic to nursing homes. “Illegal conduct like this can undermine the medical judgments of health care professionals, lead to patients being prescribed medications they do not need, and drive up the costs of health care,” Tony West, Assistant Attorney General for the Justice Department’s Civil Division, said in announcing the settlement.

Whether the fines will alter marketing practices-and by extension, prescribing habits-remains to be seen. But Sube Banerjee, a professor of mental health and aging at the Institute of Psychiatry at King’s College London, says changes must be made immediately and recommends that the use of antipsychotics be cut by two thirds over the next three years in order to minimize deaths.

But as Yale’s Rosenheck notes, billions of dollars are at stake, and changing habits can be difficult. “It’s a major problem, and it goes well beyond these drugs. It’s really the system in which they all participate and has determined the culture in which we live and think about these medications,” he says. “Once you persuade doctors to use these drugs for every mental illness, well, you can sue the company, but litigation won’t make a company go back to doctors and tell them not to use the drugs as they have been doing. The horse is out of the barn.”