The number I wrote in the original entry is actually worse, expressed as a relative risk increase — it’s 53% (I had meant to say that 1/3rd more people taking the drug reported adverse psychiatric symptoms than those taking a placebo). You say it puts the NNH at 6 (it seems closer to 7).

But the reason I didn’t trot out the NNH statistic, used in diseases where “harm” is well defined (e.g., in schizophrenia, for instance, it’s used to describe serious problems [such as tardive dyskinesia] connected to the powerful antipsychotics prescribed), is because it doesn’t seem like we’re talking about “harm” as such with this drug. We’re talking about other problems which could, but not necessarily, lead to harm. To me, it’s more of a quality of life issue and understanding that the reason you’re suddenly depressed while taking this potential drug (it’s not on the market) is because of the drug, not you.

Given the continuing stigmatization in society of many common mental disorders, people may not be aware of this connection (or told of it, unless they read it buried in the patient information pamphlet, especially if sold over-the-counter).

Continuing on since you brought this second group up, severe psychiatric side effects occurred at 3.8% in the placebo group and 4.7% in the rimonabant group. Looks like an increase but with a p=0.52 the number of patients who developed these symptoms is too small for the results to have any statistical significance. As far as clinical significance of these severe psychiatric outcomes, you get a Number Needed to Harm of 100 / (4.7-3.8) = 111. Whether the drug is worth taking when you have less than a one in a hundred chance of developing these severe effects is the patient’s and doctor’s call.

Back to the original group you were discussing, who developed much milder psychiatric side effects, such as anxiety, depression and insomnia, you had 43% of those who took rimonabant having these milder psychiatric effects compared with 28% of those who took the placebo. Now the paper gives a p

Although rimonabant has been approved in several countries, an FDA Advisory Panel did not recommend approval and requested additional safety data on psychiatric adverse effects.17 In the current trial, to more fully characterize the safety of rimonabant in a broad population, we deliberately enrolled patients whether or not they had a history of psychiatric illness. In addition, we amended the protocol to include a questionnaire designed to standardize reporting of these adverse effects. Our findings confirm that inhibition of CB1 receptors with rimonabant does increase psychiatric and gastrointestinal tract adverse effects, specifically anxiety, depression, and nausea. The inclusion of patients with a history of psychiatric illness and the use of a questionnaire increased the rate of reported psychiatric disorders in the placebo and rimonabant groups compared with prior studies. Although these adverse effects resulted in an increase in drug discontinuations, 73% of patients were able to successfully complete 18 months of rimonabant therapy, compared with 84% in the placebo group.

Severe psychiatric adverse effects, including major depression, suicidal ideation, and attempted or successful suicide were relatively uncommon, occurring with similar frequency in the placebo- and rimonabant-treated patients (3.8% vs 4.7%, respectively; P = .52). However, the study was not powered to assess severe psychiatric effects. One placebo-treated patient attempted suicide, and a single rimonabant-treated patient completed suicide. In interpreting these data, it should be noted that obesity and body weight reduction have been linked to an increased incidence of depression.33 Overall, our findings demonstrate that rimonabant is associated with an increase in psychiatric symptoms.

Reference: Effect of Rimonabant on Progression of Atherosclerosis in Patients With Abdominal Obesity and Coronary Artery Disease

And you _are_ claiming “something that is both statistically and clinically significant;” but when you look at the numbers is simply not true. You _are_ cherry picking the numbers to suit your point.

I expected better from you.

I have never claimed any company is evil, but I have written when companies make mistakes and then try and cover their tracks. I write about drugs of dubious benefits, as these seem to be. I also write of drugs and other types of treatment that seem to help people, according to the research.

Alli does help some people, and no doubt, if another weight-loss medication was approved, it too would help some people. But there’s also a greater chance of serious psychiatric side effects that people should know about ahead of time and be prepared for if/when they take such medications. That is, after all, the purpose of this blog — information and education.

43% of those who took rimonabant had adverse psychiatric effects, mostly anxiety, depression and insomnia, compared with 28% of those who took the placebo.

That’s a one-third increase in such feelings, something that is both statistically and clinically significant. [...]

Really? Using the incidence of side effects with exposure to rimonabant and their incidence to those taking a placebo, I get and Number Needed to Harm of between 6 and 7. That is, if 6 people are take rimonabant, then only 1 will develop the side effects that would not have otherwise.

So the clinical significance of these s/e’s are doubtful. And you can’t claim any statistical significance if you don’t know (or won’t tell) how many people participated in this study.

Come on. Don’t just throw out numbers that suits your agenda and expect everyone to just lap it up. You’re supposed to be a professional and cooking the conclusions to suit the point you want to make is no different than the “evil” pharmas you like to bang on here so much.

Would the side-effects really constitute mental illness since they are medication induced??