Healthy Skepticism Library item: 2526

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

Aboud L.
The Wall Street Journal, Generic Fares Well in Big Psychiatry Study
The Wall Street Journal 2005 Sep 20
http://online.wsj.com/public/us?mod=network_opinionjournal

Notes:

Ralph Faggotter’s Comments: The Wall Street Journal looks at the financial implications for the use of the new ‘atypical’ anti-psychotic agents after it is discovered that they are generally no more effective and have the just as many adverse ( albeit different) effects as the older traditional anti-psychotics.

See the New England Journal of Medicine http://content.nejm.org/cgi/reprint/NEJMoa051688.pdf for the original study and HSL2932 for more information.

Full text: The Wall Street Journal, Generic Fares Well in Big Psychiatry Study: Newer Costlier Drugs Have Little Advantage for Schizophrenia; Comparative Data on Side Effects by Leila Aboud, September 20, 2005 D-1

EXCERPT
In a surprising finding, a government study comparing schizophrenia treatments found that an older generic medicine was as effective as all but one of the newer and more expensive brandname drugs widely used to treat the mental illness.

The $67 million federally funded study also exposed just how poorly current antipsychotic drugs really work: Nearly three-quarters of people treated stopped taking the medicine they had been givern within 18 months, due to side effects or poor control of symptoms. The results, from the experience of 1,500 patients, are to be published in this week’s New England Journal of Meicine.

The findings may have significant implications for how doctors treat the 3.2 million people in this country suffering from schizophrenia. The newer, costlier antipsychotics make up 90% of the market today. They are also used for bipolar disorder, and for severe cases of depression, kids with extreme behavior problems, and dementia.

But psychiatrists have been prescribing these drugs with incomplete information about the benefits and risks of each drug. The studies that companies do to get drugs approved aren’t designed to compare available treatments or shed light on the difference between similar drugs. When companies do compare their drugs to others, the studies have often been subject to criticism that they were designed in favor of a particular drug. So psychiatrists have had no head-to-head, impartial comparison to help them weigh treatments.

Now this trial, part of a six-year push by the National Institutes of Health to examine a range of psychiatric drugs, “provides a comprehensive set of data that were obtained independently of the pharmaceutical industry and in a scientifically rigorous way,” says Jeffrey Lieberman, head of psychiatry at Columbia University and principal investigator on the trial…..

It remains to be seen whether the finding s will lead psychiatrists to change their prescribing habits. One thing to watch is whether public programs like Medicaid or private insurers use the findings to justify trying older generic medeicines before the new ones. The researchers plan to analyze the cost-effectiveness of the various treatments, using data on the rates of hospitalizations, doctors’visits and drug costs……

See also: New York Times Study Finds Little Advantage in New Schizophrenia Drugs By Benedict Carey September 20, 2005 F-1

EXCERPT
…… The findings may not significantly alter the prescribing patterns of doctors in private practice, who often do not have to worry about cost, psychiatrists said. But they are likely to have an enormous effect on state Medicaid programs, many short on funds in part because of the high cost of schizophrenia drugs.

Several states, including Kentucky, West Virginia and Maine, have limited access to newer drugs, which cost 3 times to 10 times more than the older drugs. “The
new study presents an opportunity but also a risk,” said John Goodman, president of the National Center for Policy Analysis, a policy research group based in Dallas, which estimates that Medicaid programs spend at least $3 billion a year on antipsychotics, more than for any other drug class. “The opportunity is to lower the cost of these drugs,” Dr. Goodman said. “The risk is that state Medicaid programs use this excuse to entirely deny some patients access to more effective and more expensive drugs which work for those patients.”

The government study set out to judge each drug by how long patients and their doctors continued the therapy, a criterion rarely used in studies by drug makers
but crucial in real-world practice. People with schizophrenia struggle with delusional thoughts, private voices, blunted emotions and other symptoms, and
most try multiple drugs in trying to avoid severe side effects……

The most common reasons were that the drug was not effective, the patient could not tolerate taking it, side effects like sleepiness and weight gain or neurological symptoms like stiffness or tremors. Doctors’ concerns about neurological side effects in particular have sped the switch to newer schizophrenia drugs over the last decade. Studies have shown that these medications carry a lower risk than the older drugs of tardive dyskinesia, a disorder that causes tics, lip-smacking and other involuntary movements.
But the study found that at more modest doses, the older drug, perphenazine, while just as effective, was not significantly more likely to cause neurological
symptoms. Dr. Lieberman said that there was no reason to believe that modest doses of other older drugs, like Haldol, would perform differently.

The patients on Zyprexa were less likely to be hospitalized because their condition worsened than those taking the other drugs, the study found. But these
patients also gained the most weight, adding an average of two pounds a month while on the drug, and their lipid levels increased more than those of people on
the other drugs. Weight gain and elevated lipids are risk factors for diabetes. In the doses used in the study, a month’s supply of perphenazine costs about $60, compared with $520 for Zyprexa, $450 for Seroquel, $250 for Risperdal and $290 for Geodon, according to Drugstore.com.

“Probably the biggest surprise of all was that the older medication produced about as good an effect as the newer medications, three of them anyway, and did not produce neurological side effects at greater rates than any of the other drugs,” said Dr. Lieberman in an interview.