Strattera article

“The company said a study showed instances of suicidal thinking were rare.”

“Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.”

Good to know the FDA considers 1 in 272 is a “rare’ event.

“Dr. Harold Koplewisz, a professor of child and adolescent psychiatry at the New York University School of Medicine, said that 19 percent of all teenagers have suicidal thoughts, making “suicidal thoughts in adolescents part of the normal experience.”

“There are 2,400 adolescents thinking about suicide for every one that commits suicide,” he said in an e-mail.”

2,400 to 1 is considerably different from 5 to 1, would you think? Only 48,000% difference…

Couple of things, Dad.

The FDA doesn’t state that it considers 1 in 272 to be a “rare’ event. Eli Lilly used the word rare.

The FDA said it still considers the risk to be low and the drug to be [b]effective[/b]. Effective in what, they don’t venture to say.

Also, perhaps you erred making your ratio comparison. did you mean:

2,400 to 1 is considerably different from 272 to 1?

Still considerably different, though.

The most shocking thing is the manner in which Eli Lilly treats this. The fact is that they have been made to place a very serious label on their drug. The company at that point appear to show no concern and to grind the defence machine into gear:

“The company said a study showed instances of suicidal thinking were rare. ” That’s good since it seems its common knowledge that 19% of ALL adolescents indulge it - pils or no pills.

If they were concerned wouldn’t they conduct new studies in to the new findings on possible suicide links. Or are they only concerned when the class actions kick in down the road?

Now, where does Dr. Harold Koplewisz get his figures from? 19% of adolescents are thinking about suicide? What does that mean? That they wondered what goes through a suicide’s mind, or that their lives are so bad that they’ve begun looking at the more serious options for fixing their problems? Can any survey that asks adolescents: “Have you thought about suicide?” be reliable? Would 19% respond in the affirmative to the same question rephrased for homicidal thoughts? How can he just toss off those percentages without giving more details or a source?

And, if it is true, then we might as well just pack it in. 19% of adolescents would probably translate to a much higher % of total population (does life get any better as we grow older? - if we’re thinking about suicide in college, do we miraculously cheer up later on when the real pressure hits?)- that’s around 60 million Americans thinking about suicide? It doesn’t matter if they do it or not - what’s wrong with the society that would make them think that way?

Now, is that statistic not enough to make you sit up and think that perhaps environment (society) may have more to do with “ADHD” behavior than Eli Lilly would give it credit for? The [b]19% of adolescents [/b](that’s millions of young people) don’t have “brain disorders” - they just have divorce, insecurity, neglect, pressure, etc. The same as the little boy who won’t sit still and be quiet and who is destined to consider tragic means of resolving in adolescence, what his parents tried to resolve with a pill in childhood.

Really, can anything good come form the mass medication of our youth?

You are correct that it was Lilly’s words about “rare” events. I have read two write ups about this story now, and did not see anywhere where the FDA corrected Lilly in their statement, so they must not have any issue with this. The FDA does call other adverse events associated with other emdications “rare” however, which have even higher rates of incidence (one example is the onset of tardive dyskinesia associated with the long-term use of Risperdal; in adult formulation it is understood to affect 1 in 6 people who use it for longer than 1 year, the FDA calls this “rare”).

Still, you were correct to point out the mistake I made in my posting (damn my haste!)

On the other point, I was not grabbong the wrong figures. The statement made by the “expert” of juvenile suicide was 1 in 2400 children who contemplate suicide act accordingly. In Lilly’s trial, 5 children reported thinking about suicide and 1 attempted.

Now there is a small difference in that the pyshe did not say how many children who contemplate suicide attempted it to have the 1 “success”. On the otherhand, the children taking part in Lilly’s trial would have been more closely monitored than the average teen in society.

This does make the third psychoactive drug reported to cause an increase in teen suicide attempts (Luvox and Paxil being the other two). Considering the FDA does not require the Pharmas from turning over ALL notes and study results when evaluating medication application for market, how do we establish a proper risk-benefit ratio so we can determine which drugs are worth the chance and which are not?

Since any “suicidal thoughts” information would necessarily have to be volunteered by the individuals in the study, that study has to be open to widespread abuse and skewing.

1. If I asked you: “Have you ever considered taking your own life”?, you may return a negative answer (for many different reasons - see below). Labs might like that answer. What if I rephrased the question to: “Have you ever thought about suicide?” Since suicide is a part of life in our society, and you have 2 response options, yes or no, the answer would probably be in the affirmative. Some groups may favor receiving that answer, i.e. in order to show that these thoughts are ‘normal’ and not connected with the use of a specific drug. Both sets of results could be published (or at least reported erroneously in the press) as results for: “Have you had suicidal thoughts”. We’d need to know the exact phrasing of the question asked. Even then we’d all have our own interpretation of what the words signified and the answers would still be less than reliable. So, on one hand, we’re being sold that suicidal thoughts are “normal” in teens and, on the other, via the company, that it rarely occurs when using that drug. That almost sounds like an adolescent can shed his “normal” suicidal thoughts” by USING the drug. Surely then, they should have gotten a Nobel prize and not a black label? 100% of my neurons polled said they believed manipulation of data and words is rife in all areas of our society. Don’t listen to polls - seek facts and err on the side of caution.

2. If someone conducted a poll with the question: “Do you beat your wife?” Could we expect that all those asked would return an honest response? Is shame still a human trait? Could it skew results? What about: “Have you had suicidal thoughts?” Any shame in answering yes to that? Any chance that a child would accept any escape route offered by ambiguous wording or psychological prompting? Could a child even grasp the full significance of that question without further explanation - biased on one side or the other? Can we ever rely on surveys (for that is what they are when the only evidence is the word of mouth of the participant) conducted by drug sellers? We must realise the difference between an in-house poll and a double blind scientific experiment conducted by an independent third party. Since the government has seen fit to demand a “black label” based only on these polls, should we be even more concerned regarding what is probably the reality of the effects of these drugs? It’s the most serious label a pill bottle can have. Remember that the next time you are halfing an aspirin for the same child.

3. Can we be certain that there is always a lead-up “suicidal thoughts” period before an actual suicide occurs. Are murders always premeditated? Don’t some people just snap? Can’t that happen in the case of a suicide? Can life just suck for a while and the idea present itself out of the blue at a convenient point and place in time, or prompted by an isolated circumstance? Surely, a better poll question would have been: “On a scale of 0 to 10, 0 being couldn’t-be-worse and 10 being excellent, how would you rate your life?” Why ask about plans for remedying the situation that may not have occurred to the respondee as yet? Or do we not care that life for our children is the pits, as long as they don’t come up with ideas on how to go about ending it? Parents should want to know if their children are suffering AT ALL, as a result of medication. Especially if that parent’s own “suffering” has been equally reduced by the administration of the same drug. Obviously, if some childen are suicidal as a result of taking some drugs, many, many more are somewhere on a scale from blue to very depressed. Since parents (and teachers) don’t wait until they’re suicidal before medicating “inactive, kind of reserved, farm children”, why use that as a criterion for drug efficacy? I wonder how many medicating parents keep a log of their child’s resonse to the above happiness question? I wonder how many care? Where does a child’s happiness and psychological well-being rate on a parent’s/teacher’s own happiness and psychological well-being chart? How does it import beside things like “quiet” and “good grades”?

Children should be happy, not just non-suicidal, right (don’t use your own 40-something existence as a benchmark)? Who’s doing studies on drugs and their effect on child happiness? And, finally, what can be more important than a child’s happiness?

One other thought…

I do not recall reading how long the Stratterra test was. When pychologists state “x% of teens have suicidal thoughts” they are talking of several years in the average teens life; the actual thinking of suicide which we understand to be part of being a teen is for the most part a sporadic thing and I suspect it occurs during those times in puberty when the hormones are raging the hardest. Since the Stratterra test was almost assuredly not years in length (and in fact probably only weeks in length) it is not surprising that they have a lower reported rate of suicdal thinking than might be otherwise expected.

Not to mention the fact that they screen out suicidal people before the trials begin (which I think is stated in the article or an earlier posting). Any placebo controlled study that shows a higher incidence of suicide than the general population should be of GREATEST concern, because we are talking about suicidal thinking and even action in people who were pre-screened to eliminate these possibilities. If you included people with suicidal tendencies or even significant levels of stress, depression, or anxiety, it is highly likely that these numbers would be greater even if the drug effect is small. The reason these people are excluded from the placebo study is so that we CAN say for certain that the increase in suicidal thinking (or whatever other effect is seen) is caused by the drug rather than some other condition. So the real expected rate of suicidal ideation in a placebo controlled study of this nature should NOT be the rate in general society, it should be ZERO (or at most, the rate seen in the placebo group). ANY suicidal ideation or other such effects that occur in the pacebo studies should be a big concern that should never be swept under the rug.