When drug companies hide data
June 6, 2004 1:48 PM   Subscribe

When drug companies hide data.

"The attorney general's civil suit accuses the drug giant GlaxoSmithKline of committing fraud by concealing negative information about Paxil, a drug used to treat depression. The suit says that the company conducted five clinical trials of Paxil in adolescents and children, yet published only one study whose mixed results it deemed positive. The company sat on two major studies for up to four years, although the results of one were divulged by a whistle-blower at a medical conference in 1999 and all of the studies were submitted to the Food and Drug Administration in 2002 when the company sought approval for new uses of Paxil. At that time it became apparent that Paxil was no more effective than a placebo in treating adolescent depression and might even provoke suicidal thoughts.

My Dad was on Paxil until 26 days ago..... that's when he shot himself.
posted by Lusy P Hur (45 comments total)
I am so sorry to hear that. You should contact a lawyer and sue glaxo, on the basis the medication did not help your father although it was targeted at preventing depression. Any lawyers here think that would stand in court?
posted by Keyser Soze at 1:54 PM on June 6, 2004

Sorry to hear that, Lusy :(
posted by slater at 2:05 PM on June 6, 2004

Um, the FDA approved the medication based on it's trials. That's why the prescribing info says, "Pediatric Use: Safety and effectiveness in the pediatric population have not been established (see WARNINGS—Clinical Worsening and Suicide Risk). " The company violated the law by marketing off-label use. The physicians are ultimately responsible for that use and theoretically have the expert knowledge to choose to use medication in an off-label way. The implication is that GlaxoSmithKline mislead physicians into thinking that the use was justifiable based on the single study.

As for your father, I am sorry for your loss. Blaming the medication that was used to treat his depression for an outcome that is associated with the disease is a little silly. To date, there isn't an conclusive proof that medication of any kind will create suicidal thoughts in depressed patients who don't have them already. There is an increased of suicide with treatment for some groups of depressed patients which is a very different thing but this can occur with other classes of antidepressants as well. Depression is a hard disease to treat and sometimes doesn't respond to medication at all.
posted by shagoth at 2:10 PM on June 6, 2004

trharlan, there's a missing link in your analogy, and that would be if someone marketing aspirin for its cardiopulmonary health benefits had hid information which said that it wasn't more effective than a placebo.

Failure of a drug to work as hoped is not criminal. Failure to report results of studies about drug effectiveness is.

Lusy, very sorry. This is awful.
posted by weston at 2:18 PM on June 6, 2004

skallas: not exactly. The studies lead toward the possibilities that suicide risk increases in adolescents and children or merely that people with ineffectively treated depression are more likely to kill themselves.
posted by shagoth at 2:24 PM on June 6, 2004

Lusy, I am so very sorry...

Is there any chance at all that your father could have had undiagnosed bipolar disorder? I have it, and was not diagnosed at the time I took an ssri antidepressant. In fact, in some people, antidepressants are what trigger it...these medicines are nothing to play around with. And for people like me, antidepressants can be very dangerous.
posted by konolia at 2:26 PM on June 6, 2004

I'm so sorry for your loss, Lusy.

There have been lawsuits against Paxil for a while now, and it's a wonder they still can sell it.
posted by amberglow at 2:26 PM on June 6, 2004

My condolences, Lusy. It's gutsy to put personal stuff like that on the blue; sometimes it can seem inappropriate, but in this case I think it helps to drive home the awful results of the concealment.

Here's a link to the Times editorial that won't go bad after a week.
posted by languagehat at 2:36 PM on June 6, 2004

Lusy, sorry. My mother is on Paxil and trying to get off, it is a long and difficult process and it has been hard for the whole family. Some days are better than others your story helps to take this even more seriously now, thank you.
posted by stbalbach at 2:45 PM on June 6, 2004

i tried all those miracle anti-depressants and none ended my depression. now i've resigned myself to a life of good nutrition and lots of sweat and exercise. now, if THAT doesn't work, well... i just don't know. i'm terribly sorry about your dad, lusy.
posted by quonsar at 2:52 PM on June 6, 2004

Paxil does work for some forms of social anxiety (such as mine), but I can't recall it being all that effective for depression itself. Every once in a while you do feel terribly upbeat about something non-specific, which is puzzling, but on the long run it's not the best treatment for depression.

I am likewise very sorry about your loss lusy.
posted by clevershark at 2:57 PM on June 6, 2004

An antidepressant is contraindicated for anyone who is bipolar and not unipolar depressive (either acute or chronic). Antidepressants will not be effective and will, in fact, exacerbate the mania side of the illness—which is thought to be the engine that runs the bipolar cycle.

Antidepressants vary greatly in effectiveness in individuals, and a given drug may be ineffective. If so, given that the illness treated is major depression, suicide is a risk. Suicide is by definition a risk for anyone being treated for depression. Not to mention that these drugs usually require a gradual withdrawal regimine to avoid either strong mood swings or the onset of a severe depression, and many tragedies occur because patients foolishily go "cold turkey".

It may be the case that for a small number of patients, an antidepressant, even when correctly prescribed and monitored, might be worse than ineffective and actually induce a more severe depression than would otherwise exist. If so, the number of people so affected is a tiny fraction of those whose lives have been saved by the drug. Any medical intervention has a risk associated with it, just as any activity has a risk associated with it.

More to the point, disallowing a medication, medical procedure, or activity also has a risk and a cost associated with it; and it is worse than irresponsible to demand zero risk without weighing it against that cost. Every surgery has a possibility of being fatal or iatrogenic, general anasthesia is itself life-threatening. No one demands that surgery be perfectly safe.

The truth of the matter is that the brain mechanisms underlying depression and the like are very poorly understood, and even the well-understood antidepressants are yet somewhat mysterious. These medications have costs both known and unknown. Only when the benefits are indisputably relatively large should such medications be taken. For many, many people, this is the case. Antidepressents save lives every day. Both physicians who casually prescribe or misprescribe medications such as antidepressants (or, a better target, habit-forming antianxieties, particularly Xanax), and passive, far-too-often ignorant patients bear the larger burden of the responsibility for the misuse of these drugs than do the drug companies. Make no mistake: I'm no fan of the drug companies, and I'm no fan of the relationship they have with physicians, nor their research priorities. But irrational fear and misinformation about antidepressents and, for example, vaccination, are actually dangerous to the rest of us.
posted by Ethereal Bligh at 3:21 PM on June 6, 2004

to clear it up:
i don't blame paxil solely for the loss of my father, there were a number of other factors that contributed to his death. there were noticable changes in his behavior while on the drug, and suicide was something he'd been contemplating for quite some time, so in that respect, i think paxil was a major factor. thank you all for your kind words, but please don't think of this as a sympathy plea. the point of his mention, as languagehat pointed out, was to drive home how dangerous this drug could be.

konolia, BPD was possible, in retrospect, but as you are probably aware of, it can be almost impossible to diagnose at times.
posted by Lusy P Hur at 3:49 PM on June 6, 2004

Lusy, you have my condolences. However, I must chime in with placing the blame on the medical community's current vogue for prescribing drugs for as quick (and from the perspective of insurance company's, cheap) solution for a very complex and difficult health problem, as opposed to blaming the drugs themselves. His doctors should have been monitoring him more closely and prescribed weekly or twice-weekly therapy at least until he recovered enough to get past the worst of his depression. He shouldn't have had to carry around all that pain having been given nothing more than a bottle of pills to treat it. That is outrageous and unfortunately, all too common.

I have struggled for most of my life with depression, only learning in the past few years that I have bipolar type II. Medication is what has kept me alive and relatively productive for the last 13 years. I'm lucky however that I had doctors who for the most part were very careful and dilligent in monitoring the effects of the medications.

Even so, I had a frightening experience where during a severe deep, dark depression, my doctor switched me to an antipressant that amplified my already intense desire to end my life. I hospitalized myself because I knew that I was dangerously close to acting on my feelings.

Unfortunately, meds can be a bit of a crapshoot but for people like me the alternative of no medication is far worse. Taking a new medication is taking a small risk of having an adverse reaction like the one I previously experienced. Not taking medication almost completely guarantees that I'll end up in the exact same place, albeit, much more slowly.
posted by echolalia67 at 4:27 PM on June 6, 2004

Lusy, I am so sorry for your loss. : (

I was on Paxil for a while. Not only did I gain quite a bit of weight while on it, but it completely killed my sex drive...so much so that I didn't even want my boyfriend touching me at all. Just the idea of sex turned me off. (For people who know me...that is completely unlike me.)

Needless to say, I went off it and am now on a Wellbutrin/Lexapro cocktail, which works well and does not have those side effects.
posted by SisterHavana at 4:49 PM on June 6, 2004

I have a coworker who had two family members on Paxil, his father and sister.

His father is dead (suicide), his sister permanently brain-damaged (attempted suicide).

The word "Paxil" makes my blood run cold.
posted by mr_crash_davis at 5:22 PM on June 6, 2004

Lusy, my condolences.

For anyone interested in reading about the history of treatment of mental illness in America I recommend Robert Whitaker's Mad in America. A great deal of the book is devoted to overconfident/fraudulent studies and how they can make any treatment seem like the miracle cure despite irrevocable damage to patients. It explains how the lobotomy lasted so long in this country. I thought that most of the worst frauds would have been part of the 19th century, but the horror stories run into the late 1990's.
posted by Alison at 6:32 PM on June 6, 2004

GSK is not a particularly nice company - in addition to suppressing information about Paxil's effectiveness in children, they went to great lengths to prevent the production of generic equivalents, and lied about the habit forming nature of the drug. [All of the preceding are self links - forgive the transgression, but these are issues I've spent much time considering, and the links connect to additional resources.]

That said, there's no denying that Paxil, and drugs like it, have done a great deal of good. It has improved my life, and the lives of countless others.

The problem is that GSK, Phizer and Eli Lilly have spent incredible sums on marketing schemes that target both physicians and consumers. Anti-depressants are grossly over prescribed - often to patients who might be better served by alternative treatments.

Doctors, having been wined and dined by drug companies (you'd be amazed at the perks and benefits they're treated to) often prescribe anti-depressant medication without careful consideration of a patients condition. In my case, I was put on Zoloft after a 15 minute consultation.

The solution is to make certain that your doctor is well versed in current research (rather than the marketing materials), and to insist on careful monitoring and follow-up examinations. A referral to a good therapist is a good idea too - especially if it helps head off worsening of symptoms under an inappropriate drug.

This is a complicated issue; drug companies clearly need to be taken to task for covering up important research, but this should not obscure the fact that their products help people. I've no love for GSK (I take a generic version of Paxil), but I am grateful to them for helping me get my life back.

And of course, my sincere sympathies go out to you Lusy. I've also lost a family member to suicide, and though I was very young at the time, I remember it clearly. It's part of what prompted me to seek out help when faced with my own depression.
posted by aladfar at 6:43 PM on June 6, 2004

Well, he probably shouldn't have shot himself.
posted by delmoi at 6:56 PM on June 6, 2004

"Well, he probably shouldn't have shot himself.—delmoi
Wow, and people are saying the Reagan thread is cold and heartless. Delmoi, you win the prize.

I think it's a legitimate point-of-view to not grieve for a suicide; but to fail to be sensitive to the pain of the bereaved is an entirely different issue and to go out of one's way to be hurtful...well, that's the behavior of a Grade-A Fuckwit.
posted by Ethereal Bligh at 7:04 PM on June 6, 2004

WTF, delmoi?
posted by ashbury at 7:07 PM on June 6, 2004

posted by grateful at 7:27 PM on June 6, 2004

In related relatively old news Glaxo is being beaten by italian financial police (link here). Some 4,400 medical professionals and 300 employees in Italy of pharmaceuticals firm GlaxoSmithKline took part in an illegal incentives scheme to boost Glaxo's sales.Police said the investigation had helped to save 620 million euros per year in public health spending.

I don't know how it works in U.S. , but in Italy well-informed people are aware of the fact that many doctor received many "bonus packages" under the guise of free travels (with some medical conference attached) in exotic locations, hard cash and other substantial fringe benefits.

The doctors, in exchange, prescribed Glaxo drugs instead of other drugs, even when cheaper drugs of the same type were avaiable on the market and at pharmacies. I suspect that they also prescribed drugs when drugs were not necessary or drugs that weren't as effective as others.
posted by elpapacito at 7:29 PM on June 6, 2004

Ops should have been on preview :delmoi: have you taken your pills as prescribed ?
posted by elpapacito at 7:34 PM on June 6, 2004

Drugs like these are very much a crap shoot. Where one drug can bring miraculously positive results in one person, the next person might not be helped at all, or at worst, suffer terrifying side effects. I'm no expert, but I've known a bunch of people who have gone on various drugs of this sort, and I tell them 2 things: first, if you go on Paxil, and decide to go off, gradually wean yourself. Second, if you go on a drug, and it doesn't seem to work within a month or so, or if extremely scary things happen (you'll know when they do), then march back to your doctor and ask to be prescribed the next drug in the queue.
posted by websavvy at 7:40 PM on June 6, 2004

I just want to add my condolences also, Lusy.
posted by jerseygirl at 7:52 PM on June 6, 2004

A family member of mine was prescribed Paxil for anxiety, now I wonder.

Lusy P Hur, I'm sorry.

That's all.
posted by troutfishing at 7:59 PM on June 6, 2004

I'm sorry to hear about your loss Lusy.

However, I think it is goign to be a long battle to try and hold Glaxo criminally responsible for someones suicide. Civil cases are almost by definition just a popularity contest these days so I no longer consider them a reasonable indicator of the success or failure of something.
posted by soulhuntre at 8:06 PM on June 6, 2004

The problem with anecdotal evidence like Lusy's is that it's impossible to know what would have happened if is father had not been on Paxil. Would he have killed himself sooner without treatment? Or not at all, as Lusy appears to think?

I can speak from my own (anecdotal) experience, and say that there were likely numerous factors involved, and it's likely that Lusy will never know them all.

Another point: I think one problem with antidepressants is that they give the depressed hope. As any sociologist will tell you, revolutions occur during periods of rising expectations. When a person suffering from long-term depression finally obtains some relief, any setback (from events or from growing tolerance for the meds) can be perceived as catastrophic. That's what depressed people do, after all: interpret setbacks as absolute, unrecoverable disasters. (Again, I speak here from experience.)

I think if antidepressants trigger suicide, it's likely because sometimes they lift the burden of depression just enough to motivate suicide. This is why the administration of antidepressants shouldn't be done by a general practice primary care physician. Proper counseling is essential to the healing process.
posted by SPrintF at 9:05 PM on June 6, 2004

I think something that's too weakly acknowledged in these cases is the case of someone who's currently overtly suicidal and hence a possible increase of risk is irrelevent. I've had to deal with this (with friends, that is), and from experience personally I think of SSRIs with almost a childish wonder.
posted by abcde at 10:16 PM on June 6, 2004

Lusy - you have my sympathies over your father's death.

This post ought to be deleted as a straightforward case of ignoring posting guidelines:
If posts that link to an opinion piece lead to discussions that MetaFilter doesn't do very well, then a post that drags together a few links in order to justify the poster's opinion is doubly bad.

Besides, the point of the post then becomes the poster's opinion, when it should really be about what the poster found on the web. The poster should be as invisible as possible.
If anything could make the poster less invisible, I don't know what it is. That's why you can set up your own weblog.

How, precisely, does this fit into the "interesting links on the web" category and not the "opinion plus personal life moment" category?

My heart goes out to you, Lusy, but this thread should be deleted.
posted by swerdloff at 10:22 PM on June 6, 2004

I'm confused. According to some other articles, Paxil was approved for use in Canada back on May 6, 1999 and was originally approved for use in the USA on May 7, 1996, but this one reports it was approved for use here in the USA October 17, 2003.
posted by jmd82 at 10:34 PM on June 6, 2004

Don't know about Paxil, but Zoloft fucked me up but good for the month or so when I was [illegally forced to be] on it. An old friend visited a few months back and chose the week when he was staying with me to quit taking some sort of antidepressant, not sure of the brand; he'd already gradually decreased his dose, etc. It made him fucking crazy for two or three days until he decided to start taking it again.

jmd82, I think 2003 was when it was approved for Social Anxiety Disorder; it was approved for depression much earlier. My ex-fiancé was prescribed it by an extremely reputable psych hospital in 1997 or thereabouts.
posted by IshmaelGraves at 10:43 PM on June 6, 2004

Random tangent: I couldn't find anything via Google about Paxil being approved for use in Europe. Does anyone know otherwise? I find this curious because most FDA approved drugs have been used in Europe for a number of years (think of it as a "cheap" testing ground).
posted by jmd82 at 10:55 PM on June 6, 2004

Lusy: My wife and I, both bipolar, have many many mentally ill friends (among other thing, she's a moderator of an online support group with ~5,000 members) and your story is, I'm afraid, all to common. We have seen so much anecdotal evidence against the use of Paxil that it's one of the few drugs we always warn other people to steer clear of.

I hadn't heard of any formal studies until this post that supported the oberservation that nearly every person we've seen take Paxil has had an outrageously bad experience with it in one way or another. At least now we'll have something concrete to point to. I'm very sorry for your loss.

swerdloff: I'd say this post is useful because Paxil is out there ruining lives by the truckload - which is in no way an opinion. Lusy's father - though a personal touch - simply serves here as a poignant example of this fact. Is it "best of the web?" Maybe not, but considering the disproportionately high incidence of mental illness around here, it probably doesn't need to be.
posted by Ryvar at 1:40 AM on June 7, 2004

swerdloff, shut up. *said nicely but firmly*
posted by konolia at 4:05 AM on June 7, 2004

I couldn't find anything via Google about Paxil being approved for use in Europe. Does anyone know otherwise?

google "seroxat"
posted by mr.marx at 4:10 AM on June 7, 2004

"My heart goes out to you, Lusy, but this thread should be deleted."

Let it stay. Let's face it, every other post on MeFi these days is an anti-Bush item of skewed links or editorial comment passing itself of as "news"... often (recent post as an example) pulling together a ton of similarly skewed links to try and make the point.

The idea of a MeFi post being opinion neutral or the posters bias being invisible is so far gone these days it's nothing but a memory.

If those rules can be ignored so often for political ends, at least this post is something I wouldn't have found on every other news site on the web.
posted by soulhuntre at 6:45 AM on June 7, 2004

My condolencesto you, Lusy

Meanwhile, marijuana is still very illegal as a major threat to society.

Just another day in the Ironic States of America.
posted by Fupped Duck at 6:59 AM on June 7, 2004

btw, my friend was on Paxil for *years* until she was pregnant with her *second* child. She got yanked off of it as it turns out its being linked to dirth defects.

ASk big pharm how SSRIs work to alleviate depression and they'll tell you they don't understand the mechanism, just that it works.

Reason enough to steer clear of these wonder drugs.
posted by Fupped Duck at 7:03 AM on June 7, 2004

ASk big pharm how SSRIs work to alleviate depression and they'll tell you they don't understand the mechanism, just that it works. Reason enough to steer clear of these wonder drugs.

Well, they also didn't understand how aspirin works until fairly recently. If you wait until science fully understands how a drug works before you take it, you'll die a dozen times of conditions that could have been prevented or cured.
posted by kindall at 8:47 AM on June 7, 2004

and suicide was something he'd been contemplating for quite some time, so in that respect, i think paxil was a major factor

That's a well-known side effect of most all antidepressants. They have an energizing effect, so it's very possible for there to be a period of time when you're still suicidally depressed, like you were before, but have a greater chance of having the energy to actually do it.

If there's fault here, I'd be inclined to put it on your father's physicians or psychiatrists, or with the insurance company for not covering stuff that needed to be covered.
posted by ROU_Xenophobe at 9:26 AM on June 7, 2004

I found this Slate article on a paxil/alcohol combo and then withdrawl fascinating...
posted by armacy at 10:49 AM on June 7, 2004

An antidepressant is contraindicated for anyone who is bipolar and not unipolar depressive (either acute or chronic). Antidepressants will not be effective and will, in fact, exacerbate the mania side of the illness—which is thought to be the engine that runs the bipolar cycle.

Ethereal Bligh, I am very glad you aren't my psychiatrist. I am bipolar and I am on not one but two antidepressants right now. I have not been tipped over into mania.

I think your statement is overly broad, and you know not whereof you speak.

It is true that great caution needs to be exercised when using antidepressants with bipolar people, because it can cause mania, however, this is not a 100% across-the-board truth as you suggest. The disease differs somewhat from person to person and individual reactions to specific medications differ as well, and tend to change a bit over the course of treatment (many experience antidepressant burnout, for instance).

If I believed what you said and decided to forego my antidepressants, I'd be dead. Good thing I am not taking medical advice from you. (And I suggest no one else do that either).
posted by beth at 12:01 PM on June 7, 2004

konolia: you first.

[said snidely, but sincerely]
posted by scarabic at 4:37 PM on June 7, 2004

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