"Your question is not particularly pertinent because these trials are not designed to influence suicide. If you look at any one individual trial it is very unlikely you will find a suicide in the trial, and generally we don't."

"It's only if you accumulate data across a large  number of trials that you even have enough data to look at. What you do see in individual trials is that patients who get drugs improve more than patients who get placebo. That's what we see.

 

When you do a meta-analysis  across a large number of trials and you look at the other outcomes of suicide and attempted suicide, you don't see any particular benefit from being assigned the drug compared to placebo."

"the drug is not approved for the treatment of suicide. They are approved for the treatment of depression. Dr. Khan's findings and our findings suggest that these drugs that we're studying and approving for depression don't appear to have a benefit on the outcome of suicide. That is not to say that they don't have a benefit in treating depression."

"What this [increased suicide rate] would tell us, is that this is a serious condition, not a trivial condition. Depression is a serious condition. If you look at individual trials there are so few suicides that you wouldn't be able to make sense of it all. It's only after  you look across multiple development programs over a very long period of time that you have enough events that you can get this kind of analysis." 

"because the data are very clearly showing that these drugs benefit patients. What this tells us is that it is very difficult to exclude patients that are suicidal. As hard as  you try you really are not able to predict who is suicidal and who is not.

 

It [the trial data] does not tell us that being in clinical trials puts you at risk of suicide. It is not surprising to see a few suicides when you look at a fairly large number of patients, many of whom are followed for months or years."

"Clinical trials are skewed against the placebo."

"What happens in these drug trials is that people who respond well are put into an extension of the trial. The point is that the longer people are kept on whatever arm they're in - either placebo or drug - you expect suicide rates to drop over time. It's only the good responders  through the six-week trials that are put into the extension trials, and so it's biased against the placebo because after six weeks no one is kept on to do extensions on placebo."

"You shouldn't be seeing four to five times the suicide rate  in drug-treatment groups, especially when these drugs are supposed to  prevent this. It's terrible that the FDA approved drugs with these high suicide rates. Naturally they do expect some suicides, but the question is  whether there is something the drug is doing that is increasing that rate, and here it looks like it may be. A further question that has to be asked is why it has taken 15 years to find out about this data. Why are we  learning about these increased suicides in clinical trials 15 years after the drugs were approved?"

"There are  two questions that need to be raised about the FDA review. First, is there an elevated suicide risk beyond the background rates [number of depressed people in the population] such that the drug should be seen as unsafe?

 

And, second, is there enough of a hint of suicide risk that it needs labeling?  Is a public warning needed with the SSRIs?"

"confirmation of what a lot of people have  been complaining about for many years. An analogy would be that you have some disease, like cancer or heart disease, and you're going to see death in those trials. The question with the new treatment is, 'Are you getting a lower, higher or no difference in the number of deaths?'

 

There is a key piece of information missing from Dr. Khan's research and that is the background rate for depression. Even so, we should be seeing in these trials a lower rate than the background rate because people who are suicidal are excluded from participating in the clinical trials - they are supposed to be testing these drugs among safe populations. This data tells me something is very wrong."

"In the case of trials for depression and anxiety disorders, suicide rates were in fact higher among those who received the investigational drugs than the placebo."