Long ago I learned to ignore most of what is printed in the New York Times, the paper I read cover to cover everyday for 40 years but canceled two years ago when the internet offered alternative sources of information and the Times agenda journalism became too much to bear. I still check out the front page on line and occasionally check out an article. Until recently I naively thought that there might be areas in which the Times played it straight with the news. Their misreporting of an issue with which I am quite familiar should disabuse me of that notion for good (but probably won't.)
Here is the title of an article in today's science Times: Little Difference Found in Schizophrenia Drugs
The title contains a misstatement (if one is charitable) or a lie (if one is not) as will be seen in a moment. The article purports to report on a study published in the September 19, 2005 New England Journal of Medicine on the Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia. Some highlights from the Times article include:
A landmark government-financed study that compared drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few - if any - benefits over older medicines that sell for a fraction of the cost.
In the entire article, the only place in which any support for the newer drugs appears is in the third paragraph:
One of the newer drugs, Zyprexa, from Eli Lilly, helped more patients control symptoms for significantly longer than the other drugs. But Zyprexa also had a higher risk of serious side effects - like weight gain - that increase the risk of diabetes.
Toward the end of the piece, the article quotes a number of Doctors for the Drug companies suggesting that the study offered some support for their contention that they are safe and effective. The last paragraph quotes one of the study lead authors:
"The message is the glass is half full," Dr. Lieberman said. "The drugs work but they are not satisfactory to many patients, and three-quarters of the people in our study voted with their feet and discontinued the drugs."
Because I have a fair amount of familiarity with all the medications mentioned and I have seen in my patients very significant improvements in patients' experiences with the newer versus older drugs, I thought I would see if the study actually supported the headline. After all, we perform double-blind experiments expressly because anecdotal evidence is so often incorrect. Strangely enough, almost immediately, it became clear that the reporter had either not read the study or misunderstood what he read. Quoting from the actual study report is this:
The newer agents appear more efficacious than conventional drugs in reducing negative symptoms (e.g., lack of emotion, interest, and expression), possibly owing to the absence of extrapyramidal symptoms or other secondary causes of negative symptoms (e.g., depression) rather than to direct therapeutic effects.
I would imagine most people would agree that a drug that didn't cause negative symptoms like those listed, or depression, would be a major improvement over drugs that do cause such problems. Many patients who have switched from older, cheaper drugs, to the newer, expensive drugs report feeling that they have returned from the living death and feel fully alive for the first time in years. I would suggest this is not, as the Times reporter would say, a "little difference."
The study relies on a single measure to determine efficacy; that is, how long the patients stay on the drug. However, in looking closer it appears that in all measures, Zyprexa is beneficial, though the authors do what looks like statistic sleight of hand to minimize its advantage by averaging all the new drugs versus the older drug (Perphenazine) they use. I might add that the authors use relatively low doses of medication and this likely has something to do with their high relapse rates and discontinuation rates.
The time to the discontinuation of treatment for any cause was longer in the olanzapine (Zyprexa) group than in the quetiapine group (hazard ratio, 0.63; P<0.001), the risperidone group (hazard ratio, 0.75; P=0.002), or the perphenazine group (hazard ratio, 0.78; P=0.021) (Table 2). However, the difference between the olanzapine group and the perphenazine group was not significant after adjustment for multiple comparisons (required P value, =0.017).
The time to the discontinuation of treatment for lack of efficacy was longer in the olanzapine group than in the perphenazine group (hazard ratio, 0.47; P<0.001)
The emphasis is mine. Without going into the details, it is clear that patients in this study stayed healthy longer and discontinued the medications much later than in the old, cheap drug group. The biggest problems with Zyprexa are sedation, which can usually be dealt with by taking it at night and only rarely will lead to discontinuation, and weight gain (~30% gain significant weight on the drug) with its attendant possible increased risk of Diabetes. This is a serious side effect, however, many patients who have been faced with the choice of a weight gain and chronic illness of some severity or medicines which they found less effective with more troublesome side effects, have chosen Zyprexa. And then there is this:
Fewer patients in the olanzapine (Zyprexa) group than in the other four groups were hospitalized for an exacerbation of schizophrenia (11 percent vs. 15 to 20 percent, P<0.001). After adjustment for the different durations of treatment, the olanzapine group had a risk ratio for hospitalization of 0.29 per person-year of treatment, as compared with risk ratios of 0.45 to 0.66 in the other groups.
I have not been convinced that the other, newer anti-psychotics tested in this study offer significant advantages over the older medicines in terms of efficacy in treating positive psychotic symptoms (auditory hallucinations, delusions) though they do seem much better for the negative symptoms mentioned. I would add to this that Perphenazine has long been known as one of the older anti-psychotics least likely to cause the serious side effects that the newer ones were designed to avoid. At the low doses used int he study, most of these drugs do not cause serious neurological problems (Tardive dyskinesia and extra-pyramidal syndromes). However, the study is significant for its support of the contention that Zyprexa is a major advance in the treatment of the most debilitating psychiatric disorder, Schizophrenia.
Perhaps the Times reporter meant to write a different story with a different headline: "New Medication for Schizophrenia Offers Major Improvement Over Older Medicines While Presenting Difficult Choices." Of course, it is possible that this story merely moves forward the story line that appears in many Times stories about the greed and maliciousness of the drug companies who continually find new ways to suck money form the poor and helpless.
Recent Comments