FDA lied to Congress about child suicides related to antidepressants

[shereads]

A year ago, a friend's daughter took her life, after months of what seemed to be a dramatic recovery from depression. She was taking Paxil on the advice of her doctor. Today I read this in the Washington Post:

FDA Told Its Analyst to Censor Data on Antidepressants

By Shankar Vedantam
Washington Post Staff Writer
Friday, September 24, 2004; Page A08


A Food and Drug Administration medical officer was told by top agency officials to delete material on the risks of antidepressant drugs from records he was submitting to Congress and then to conceal the deletions, according to documents released yesterday at a hearing on Capitol Hill.

A bipartisan panel said the FDA also repeatedly prevented Andrew D. Mosholder from disclosing his conclusions that the medications increase the risk of suicidal thoughts and behavior among children, potentially delaying the issuance of a public warning. During the day-long hearing, legislators repeatedly accused the agency of obfuscating the risks, slowing action and subjecting Mosholder to harassment.

The disclosures added a new dimension to a year-old controversy over the use of antidepressant drugs in children, which led a government advisory panel to recommend last week that the FDA require a strongly worded "black box" warning on the medications. While depression itself is known to increase the risk of suicidal behavior, two FDA analyses, including one by Mosholder, have concluded that the drugs may double the risk of suicide among some children.

After revelations that Mosholder was asked not to present his findings at a public forum in February led to an outcry, the agency's internal investigative arm told Mosholder he might be subject to disciplinary action, the documents showed. He was asked whether he had leaked his findings to the news media and denied doing so.

He then prepared a sworn statement about his findings and stated that he had been targeted by the internal inquiry. When investigators working for Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) sought a copy of his records, Donna Katz of the FDA's Office of Chief Counsel urged him to delete material from the statement and submit a cleaned-up version.

"I don't think it's necessary to indicate this document represents a version of the earlier one by noting that things have been omitted; that simply invites the committee to ask further questions about what was omitted," Katz wrote in an e-mail to Mosholder on May 4.

Among Katz's suggested edits was a section where Mosholder stated: "I understand this statement is part of the Office of Internal Affairs investigation and have been informed that I may be subject to disciplinary proceedings."

Investigators from Grassley's committee, as well as the House Energy and Commerce subcommittee on oversight and investigations, which conducted yesterday's hearing, have said they were outraged to learn that Mosholder had been the subject of an internal inquiry and disciplinary threats.

Mosholder declined to make the changes Katz requested, saying they would be tantamount to perjury. He asked instead to black out the material, which would have let congressional investigators know there had been deletions. The FDA said the deletions were required because agency rules require that ongoing investigations be kept secret.

The hearing produced new demands from legislators to know why the FDA did not respond sooner to concerns about the widely used antidepressants. Mosholder said he found as early as last September that drugs such as Paxil, Zoloft and Effexor were associated with an increased risk of suicide among children.

Agency officials praised his work but did not act on it, citing a lack of confidence in the data. Even after British regulators warned doctors not to prescribe most antidepressants to children last December, the FDA declined to make Mosholder's findings public. Instead, they had the data reanalyzed by Columbia University scientists. That evaluation resulted in a report last month largely identical to Mosholder's findings a year ago.

"Was the public health served by a longer deliberative process in this case?" asked Rep. Greg Walden (R-Ore.).

Robert J. Temple, the FDA's associate director for medical policy, defended the agency's cautious approach. He said regulators are days from issuing new warnings about the drugs and perhaps "a couple of weeks" from "probably" acting on the recommendation that the labels carry a prominent warning. Regulators are weighing whether to add to the labels information about studies that found most of the drugs to be no more effective than sugar pills.

Another document released yesterday showed that as far back as 1996, an FDA official had suggested an increased risk of suicide among children taking Zoloft. Rep. Joe Barton (R-Tex.) asked why the finding had not been followed up.

"When did the FDA first become aware of a potential link between antidepressants and suicidality in children, and what did they do to get to the bottom of it?" asked Barton, who chaired the hearing.

FDA officials acknowledged that a letter sent at the time to Zoloft's manufacturer, Pfizer Inc., is no longer in the agency's files.

Agency officials repeatedly said that they were worried that the controversy would needlessly frighten parents and families away from useful drugs. Many clinicians believe the drugs are effective against depression.

 

[dr_mabeuse]

We've discussed this before, and this is a tough one. What should be the FDA response? Should it discourage doctor's from prescribing anti-depressents to depressed children? Should they be taken off the market? Should doctors be required to tell parents to keep a closer eye on their medicated child? Don't parents already do that?

If you had a seriously depressed, possibly suicidal child, whould you put them on medication knowing that it might help but knowing that it might increase the risk of impulsive suicide too? Or would you just gut it out and hope they wouldn't kill themselves because of the depression?

It's a tough one.

---dr.M.

 

[Lucifer_Carroll]

If you had a seriously depressed, possibly suicidal child, whould you put them on medication knowing that it might help but knowing that it might increase the risk of impulsive suicide too? Or would you just gut it out and hope they wouldn't kill themselves because of the depression?

It's a tough one.

---dr.M.

Hope they have good friends who know the hiemlich.

I don't know. I had a couple of suicidal friends, none actually made it. I don't see how the pills are supposed to work. They seem to just be a false crutch no different than booze and cannibus. A way to destroy the mind to keep it from thinking about death.

Personally with all the horror stories about anti-psychotic drugs, I feel pretty good as an unmedicated psychotic.

 

[Guest]

Thanks, she -

Yes - we've been following this story.

Our daughter is extremely intelligent but perfectionistic to the point of actually keeping herself awake at night with worry.

She is on the smallest dose of Zoloft which we cut in half. Without the drug she'd be in frustrated tears half the time.

Now what are we supposed to do? It seems every type of anti-depressant is not recommended for children.

We see an incredible child psych and I've already emailed him about possible options. Hopefully he has suggestions.

 

[dr_mabeuse]

Hope they have good friends who know the hiemlich.

I don't know. I had a couple of suicidal friends, none actually made it. I don't see how the pills are supposed to work. They seem to just be a false crutch no different than booze and cannibus. A way to destroy the mind to keep it from thinking about death.

Personally with all the horror stories about anti-psychotic drugs, I feel pretty good as an unmedicated psychotic.

Yes, they are crutches if you want to look at it that way. So is heart medication and antibiotics, I suppose.

I only know that I was unable to write for over 20 years because of my depression, which told me that everything I wrote was crap, and I was unable to do most of the things I saw people around me doing, like taking any pleasure in accomplishments or finding satisfaction in work or relationships, and I always blamed myself. That's how depression works.

Personally, amphetamines work better for me, and I self-medicated for many years, but they're illegal, and anti-d's are the best I can do. They don;t make me high, they don't make me expecially happy. They do relieve me of the most crushing pain and despair, and if that's a crutch then just call me crippled.

---dr.M.

 

[dr_mabeuse]

Hope they have good friends who know the hiemlich.

I don't know. I had a couple of suicidal friends, none actually made it. I don't see how the pills are supposed to work. They seem to just be a false crutch no different than booze and cannibus. A way to destroy the mind to keep it from thinking about death.

Personally with all the horror stories about anti-psychotic drugs, I feel pretty good as an unmedicated psychotic.

Yes, they are crutches if you want to look at it that way. So are heart medication and insulin and antibiotics, I suppose.

I only know that I was unable to write for over 20 years because of my depression, which told me that everything I wrote was crap, and I was unable to do most of the things I saw people around me doing, like taking any pleasure in accomplishments or finding satisfaction in work or relationships, and I always blamed myself. It was always my fault but I couldn't do anything about it. That's how depression works.

Personally, amphetamines work better for me and I self-medicated for many years, but they're illegal and anti-d's are the best I can do. They don't make me high, they don't make me especially happy. They do relieve me of the most crushing pain and despair and on the whole make life more worth living, and if that's a crutch then just call me a cripple.

---dr.M.

 

[Virtual_Burlesque]

I don’t believe that anyone should decide to suppress these antidepressants based upon this article. What it shows is more a defect in the FDA, than in the drug.

Different medications react differently with different people and different problems. Withdrawing a medication for all because it does not work for some people is no answer.

What should have happened is that the FDA should have published a warning to physicians about the possible problems and what to look out for. In the meantime, more testing should have been ordered to determine what causes the different reactions, and how to anticipate who will respond adversely.

Meantime, doctors would have had to refrain from handing them out like candy as a cure-all, only resorting to it in serious cases, and then under close observation.

By not warning about the problems the FDA abrogated their mandate to protect the public and exposed their subservience to the pharmaceutical companies they are supposed to police.

I feel certain that few people were surprised to learn that those pharmaceutical companies' most important consideration was neither public welfare nor anything philanthropical.

When a full investigation has been made, those who are responsible for withholding the information should face serious charges — reckless disregard, at least.

 

[Colleen Thomas]

Hope they have good friends who know the hiemlich.

I don't know. I had a couple of suicidal friends, none actually made it. I don't see how the pills are supposed to work. They seem to just be a false crutch no different than booze and cannibus. A way to destroy the mind to keep it from thinking about death.

Personally with all the horror stories about anti-psychotic drugs, I feel pretty good as an unmedicated psychotic.

If you can function without them, then you have an option. I, and many people who suffer the same kind of depression I do, do not. I could have Lucky, Lou, Min, Abs, Mats, Des and all the rest of the women here sitting in my liiving room taking numbers to take me to bed and without my meds I wouldn't have the energy nor inclination to take them up on it. Even worse, I wouldn't find the situation wonderous or even nice. No color. No hue and cry. Without them the world is just a blank gray landscape without significant features.

A year of my life is a great, gaping hole in my memory, with only one day standing out, and that day was a tragedy, when a friend lost her arm in an automobile accident. Depression made the world so drab, I have no memory of the events. The neurotransmitters in my brain do not balance and without drugs noting is good. For me, and a lot of people, anti-depressants are hardly a crutch.

There is a significant stigma to mental illness in this country. I know several men who suffer from depression, but would never go to a doctor. Women too. It's difficult enough to get someone to admit they have a problem, even more difficult for a parent to admit to themself that their little angel has one.

If you further stigmatize anti-depressants the possibility is strong parents will not allow thier children to go on them. That's the big fear when it comes to studies like this. One of the strongest paradoxxes of severe depression is that you are too listless to even go to the trouble of taking your own life. When the ad's first begin to work and you find energy again, that is when many people find the will to do what they have been contemplating for a long time.

Supressing evidence like this, can have the very best of intentions. A panic that has children who need help not getting it is a very real possibility. At the same time, not warning parnts seems particularly callous. But where do you draw the line? At what point does the risk to children who are on the drugs out weight the fear that those who need them might not get on them? I don't envy anyone who is in the position to make that decision. I thank god I am not, because I frankly have no answer at all.

-Colly

 

[sweetnpetite]

We've discussed this before, and this is a tough one. What should be the FDA response? Should it discourage doctor's from prescribing anti-depressents to depressed children? Should they be taken off the market? Should doctors be required to tell parents to keep a closer eye on their medicated child? Don't parents already do that?

If you had a seriously depressed, possibly suicidal child, whould you put them on medication knowing that it might help but knowing that it might increase the risk of impulsive suicide too? Or would you just gut it out and hope they wouldn't kill themselves because of the depression?

It's a tough one.

---dr.M.

Certainly a tough desision, and one for each parent to make for *their* child, not for the FDA to make by witholding information so that parents and doctors are not able to make informed chocies.

Doctor's *should* tell parents to keep a closer eye on medicated children. Many parents may feel that w/ the med they can now relax because their kids will be fine. Even if parents already do, doctors should stress the importants of it anyway, and be able to tell them *speciffically* which behaviors or other indicators are normal (with the meds) and which are worisome. And then of course- they should be clear what the parent should *do* lest a parent with good intentions do the *wrong* thing, like suddenly taking child off medications in certain cases- or just stopping and not seeing the doc (since we've lost faith in the doctors ability- after all s/he* perscribed the meds s/he* said things would get better)

How the FDA should respond is *honestly.* You can't solve problems by sweeping them under the rug. They should do there job, (at least try to) be unbiased, and *protect* consumers and children. NOT try to protect drug companies instead.

 

[Colleen Thomas]

Certainly a tough desision, and one for each parent to make for *their* child, not for the FDA to make by witholding information so that parents and doctors are not able to make informed chocies.

Doctor's *should* tell parents to keep a closer eye on medicated children. Many parents may feel that w/ the med they can now relax because their kids will be fine. Even if parents already do, doctors should stress the importants of it anyway, and be able to tell them *speciffically* which behaviors or other indicators are normal (with the meds) and which are worisome. And then of course- they should be clear what the parent should *do* lest a parent with good intentions do the *wrong* thing, like suddenly taking child off medications in certain cases- or just stopping and not seeing the doc (since we've lost faith in the doctors ability- after all s/he* perscribed the meds s/he* said things would get better)

How the FDA should respond is *honestly.* You can't solve problems by sweeping them under the rug. They should do there job, (at least try to) be unbiased, and *protect* consumers and children. NOT try to protect drug companies instead.

There is a problem with scientific studies and reports, Doc M. can correct me if I am wrong, but for a study to be deemed valid, the results must be reproduceable in another lab.

There have been a lot of studies and discoveries which seemed promising, but were not reproduceable by other scientists in a controlled enviorment and thus had to be thrown out by the scientific community at large. Off hand, the "memory of water" was one.

The FDA was right to not want to publish something with the potential to cause harm like this has, until the study was cobobarated. Once support came from independant sources they acted in a way that is at the least irresponsible, if not reprehensible. Still, I don't think anyone can jump to the conclusion that the actions taken were taken to protect drug companies. That is oversimplifying a rather complex question, IMHO.

-Colly

 

[dr_mabeuse]

There is a problem with scientific studies and reports, Doc M. can correct me if I am wrong, but for a study to be deemed valid, the results must be reproduceable in another lab.

-Colly

That's kind of what I expect happened: conflicting studies or interpretation of the data. You might have one study that found 4 suicides per so many depressed patients without AD’s, and another that found 5 suicides per same number of patients who were taking AD’s but also you have 30% of the users showing marked improvement compared to zero in the control group. What's your call? A warning? Do the results show a causal relationship between AD's and suicide?

First of all, are these studies valid? Are the results statistically significant and actionable? The numbers don’t lie but their interpretation may vary from researcher to researcher. Secondly, what will be the public health effect of reporting these findings? Do most parents have the statistical background to understand these numbers? Do most pediatricians have the time?

All my medications come with huge fold out information sheets that list all sorts of possible side effects that were encountered in clinical trials. I suppose it's my responsibility to read them, but I never do. They all say that depressed patients should always be closely monitored.

Some time ago the results of morbidity in children given DPT vaccinations (I think it was DPT) were released. Although the advantages of vaccination far outweight the disadvantages, there is a small but certain number of deaths caused by DPT vaccination, and parents started refusing to have their kids vaccinated. The same thing happened with the Alar scare. Small amounts of the pestricide alar were found in apples. It was never found to be harmful, but in a congressional hearing that eminent epidemiologist Meryl Streep testified that she wouldn’t give her children apples anymore and suddenly kids across the country stopped eating apples and drinking apple juice.

It’s really troublesome when you see the FDA being used as a political football, but the fact is that it’s become more political under this administration. (I know, I know: more Bush-bashing. Well, the politicization is undeniable and more than a few scientists have publicly complained about the way government science is being made to play politics under this administration. It’s unprecedented.) Especially when it comes to the morning-after birth control pill, the FDA is disguising morality as science. They also seem to be bowing more than usual to the pressures of the pharma industry.

So, as I said, it’s hard to know what to think about this.

---dr.M.

 

[thenry]

The study is more complicated than that. The study in question is a retroactive case study of patient records and the criterion for inclusion is not suicide but demonstrating "suicidal behavior," and unlike actual suicide participants can be included more than once. This is a good article discussing the study's statistical difficulties.

I, too, lost a year of my life to a black hole without memory. It usually doesn't bother me because I kept a journal at the time and can answer most objective questions. (Though it's become clear I was probably lying to myself on more than one occasion. I hope the bastard was laughing at the time.) Some questions continue to stump me, such as what I ate all year. I have no memories of regular eating. After months of heavy thought and reconstruction, I think I may have had a lot of oatmeal, but it doesn't satisfy me.

 

[shereads]

I think it's important to mention here that I'm a big fan of antidepressants. They saved my life. I'm not convinced that the link with suicide in children is any stronger than the old rumors about Prozac causing suicide in adults - Possibly it's just a case of the drug not having worked very well, in someone who was suicidal anyway.

Setting aside the issue of a causal relationship, here are a couple of things I've read since my friend's teenaged daughter took her life, that parents might want to be aware of:

Antidepressants that are proven effective in adults have not yet shown the same promising results in children. In fact, one study - I think it's referenced in the article above, as one of the studies the FDA tried to suppress - showed no better results in depressed children than with placebo.

(I've been hearing about Placebo for years, and I can't wait to try some of that.)

Parents of children who are taking an antidepressant should be aware that suicide may follow an apparent, sudden "cure" that's so dramatic, it seems too good to be true. For weeks before she died, my friend's teenaged daughter was so happy that virtually everyone commented on the change in her. This was a girl who had been in such bad shape she was cutting herself before her parents insisted she leave college and get treatment. She went from the lowest low to a degree of happiness that in retrospect, seems very much like the "manic" phase of bi-polar disorder.

I've read one theory that, in a child who suffers from bi-polar disorder and is misdiagnosed with depression, the "down" phase of the disease may be suppressed by meds to an extent that when it re-emerges, even for an hour or two as was the case with N., the low can be overwhelming. N. had a single, embarrassing incident with a stranger who called her childish, and her months-long happiness was transformed into something so bleak, she took her life without any explanation.

I've been in that pit of despair; suicidal depression is a state of utter hopelessness and self-loathing that may have nothing to do with circumstances. Ordinary slights cut to the bone; simple chores seem insurmountable. It was all I could do to summon enough concern for my own life that I was willing to try an antidepressant. For a teenager, who lacks the life experience to know that everythiing - even hopelessness - changes, it must be even worse.

If I were a parent, and aware that these drugs work diffferently in children and teenagers, I'd try to be wary of a sudden cure that seems too good to be true, and I'd ask my child's doctor to be on the lookout, also, for "better than well" behavior.

Antidepressants don't, or shouldn't, create happiness. They don't make you high, and they leave you open to appropriate sadness and grief. All they do - and it's a significant "all," when you're close to the point where the fact of being alive is almost too awful to bear - is give you back the capacity to feel normal emotional reactions, both good and bad. If a kid on antidepressants seems happier than she has reason to be, it might be something to take up with the prescribing doctor.

 

[thenry]

SSRIs exacerbate bipolar disorder. For the last few years, one of the most reliable pathways to a bipolar diagnosis has been the side effects associated with treatment by SSRI of misdiagnosed depression. SSRIs should only be perscribed for bipolar disorder with a corresponding mood stabilizer.

 

[SlickTony]

I hope to God this flap doesn't result in nobody giving antidepressants to kids anymore. My son has been taking fluoxetine for years--to counteract the depressive effects of the ADD meds he has to take. He has shown no signs of wanting to commit suicide.

I had a friend who was put on Prozac as an adult, and ended up going off them because she tended to beat people up, while she was taking them. Of course, being black and growing up in Natchez, Mississippi, a town where one half the people used to own the other half of the people, and no one has ever forgotten this, couldn't possibly have had anything to do with it...

I suffered from depression for years when I was a kid. Of course, nobody knew it was depression back then. It was just that during the day, I had the overwhelming desire to sleep, felt constantly tired, a sort of deadly languor--sort of like finding oneself stuck on a planet where the gravity is greater than the gravity of the planet you came from. It got labeled as "laziness"--just as the ADD symptoms got labeled as being "willful" and "recalcitrant"--words that, to this day, I have expunged from my vocabulary. Of course this was back in the 50s and early 60s, and parents and teachers could not have been expected to know anything about this. Back in those days, you occasionally heard hush-hush talk about this or that adult having a "nervous breakdown" and having to Go Away somewhere.

That's why it's so important that kids not be thrown back on being told, "You're going to have to snap to, straighten out, and fly right!" when they're in trouble from emotional and neurological stuff.