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  1. #1
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    Unfavorable drug studies don't get into print

    BOSTON (Reuters) - Nearly a third of antidepressant drug studies are never published in the medical literature and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday.
    In some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University.
    Even if not deliberate, this can be bad news for patients, they wrote in their report, published in the New England Journal of Medicine.
    "Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," they wrote.
    The idea that unfavorable test results are quietly tucked away so nobody will see them -- sometimes call the "file drawer effect" -- has been around for years.
    The Turner team used a U.S. Food and Drug Administration registry in which companies are supposed to log details of their drug tests before the experiments are begun.
    "It tells you where they placed their bets before they saw the data," Turner said in a telephone interview.
    Of the 74 studies that started for the 12 antidepressants, 38 produced positive results for the drug. All but one of those studies were published.

    http://news.yahoo.com/s/nm/20080117/...gdHKInYOus0NUE

  2. #2
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    Oh yeah-this is a surprise! For years the maker for Effexor has been denying that that a side effect of Effexor XR is the "brain shiver." The half life of this drug is very, very short, so if you do not take it at exactly the same time every day, your brain starts withdrawal. Now it is finally stated as a side effect-years too late for those who have to go through 8 weeks of "Effexor withdrawal" before they can function. In fact, doctors are trying to find ways to mitigate the wean and other than a heavy hitter like Valium, you have to be prescribed Prozac. It is the same story with Zoloft...years of the drug companies denying a known side effect that they filed away....love it.

  3. #3
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    I took Effexor XR for one month and only one...it made me feel worse than I ever have.
    I've taken trazodone, it didn't help.
    I am currently (and have been) on lexapro for awhile...some months it seems to work, some months it doesn't. Sometimes I feel like nothing is ever going to help. I get so fed up with it.

  4. #4
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    Am I reading this correctly?

    Nearly a third of antidepressant drug studies are never published in the medical literature -
    and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday.

    Am I reading this right? Are they saying now that the SSRIs and SSNRIs do NOT work? The drugs listed by name which were tested are in this paragraph from the article on Yahoo:

    "For example, of the seven negative studies done on GlaxoSmithKline's Paxil, five were never published. The researchers found three studies for GSK's Wellbutrin SR, but the two negative ones never reached print.
    There were five studies for Pfizer's Zoloft, but the three showing the drug to be ineffective were not published. A fourth study, ruled questionable by the FDA, was written and published to make it appear that the drug worked."

    So, am I right in my perception that the majority of people who show improvement in clinical depression while taking either Wellbutrin, Paxil or Zoloft are either displaying the placebo effect or would have recovered on their own???
    Please tell me I am missing something here.

    This is as bizarre as the recent article which promotes ECT therapy resurrection as it is an effective and safe way to treat depression.

    How many billions of dollars have been made off people in distress with these drugs, and how many people have been harmed by side effects or worsening depression leading to suicide? OMG.

    One last thought- IF this study turns out to be flawed in some way, as some do, it may negatively impact people who are having good responses to their anti-depressant medication, for whatever reason. This is a lose- lose mental health situation, as results are stated in this study.
    Last edited by SeekingJana; 01-20-2008 at 02:48 PM. Reason: edited to name the drugs in the study


    "Acquiring a pet may be the only opportunity a human has to choose a relative".

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  5. #5
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    Quote Originally Posted by SeekingJana View Post
    Nearly a third of antidepressant drug studies are never published in the medical literature -
    and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday.

    Am I reading this right? Are they saying now that the SSRIs and SSNRIs do NOT work? The drugs listed by name which were tested are in this paragraph from the article on Yahoo:

    "For example, of the seven negative studies done on GlaxoSmithKline's Paxil, five were never published. The researchers found three studies for GSK's Wellbutrin SR, but the two negative ones never reached print.
    There were five studies for Pfizer's Zoloft, but the three showing the drug to be ineffective were not published. A fourth study, ruled questionable by the FDA, was written and published to make it appear that the drug worked."

    So, am I right in my perception that the majority of people who show improvement in clinical depression while taking either Wellbutrin, Paxil or Zoloft are either displaying the placebo effect or would have recovered on their own???
    Please tell me I am missing something here.

    This is as bizarre as the recent article which promotes ECT therapy resurrection as it is an effective and safe way to treat depression.

    How many billions of dollars have been made off people in distress with these drugs, and how many people have been harmed by side effects or worsening depression leading to suicide? OMG.

    One last thought- IF this study turns out to be flawed in some way, as some do, it may negatively impact people who are having good responses to their anti-depressant medication, for whatever reason. This is a lose- lose mental health situation, as results are stated in this study.
    yes, my friend you got this right. There are cases of intractable depression that are biochemical and may be effectively treated by antideppressants or ECT. There is a fantastic brand new study indicating that PPD may be caused by excess copper the new mother has in her body that doesn't get shed as quickly as it should, in conjunction to her hormone levels not "leveling out" after delivery. Neither the copper or the hormone issues are effectively addressed by SSRI's.

    The same FDA that approves these drugs and allows for the suppression of data is the same FDA that says it is OK to eat cloned animals, genetically engineered veggies and that there is no relationship to heavy metals and autism. Just sayin.

  6. #6
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    csds-- THANKS for posting this. This makes my day!!! I've been saying this for YEARS. Maybe if some drugs help some people somewhere.. that whatever works for them, that's a good thing. (even if it may be the placebo effect).
    However.. the pharm companies rule the media.. and it does not surprise me that any research showing that antidepressants don't work very well, got shelved. IN fact I always kind of suspected this. And yet, they have those nice little explanations, with the little drawings or videos of the neurotransmitters crossing the synapse, and how in the depressed person the next cell gobbles them all up,, and how with the SSRIs, it leaves many of the neurotransmitters in the synapse, therefore making them more usable... and so on. But does anyone REALLY know what the pills are doing to your brain??
    It always amazed me how we have diagnostic machines to figure out what's wrong with our cars.. and yet.. we do not have diagnostic machines to figure out exactly what's wrong with our brains.. even though we surely have the technology.... WHY is this....???
    Instead, we have docs prescribing pills and getting kickbacks from companies to do so.. and they are truly groping in the dark, when it comes to what is going on in our brains!!!

    When you look at online forums, you will see thousands of desperate, frustrated souls pleading about how their pill worked for a short time and why did it stop working? ..and how they switch to another, then another, then another,, and nothing works.. and they are almost ALL screaming about the horrible side effects..... I remember on such forum... it may be gone now... but my point is,, this is only the tip of the iceberg.
    I do believe these pharm companies are criminally negligent and I despise the way they advertise so heavily making people believe this is the answer to your problems.... and how docs get people addicted to them for the rest of their lives (in many cases).... and you have people dealing with other symptoms and withdrawal issues that cause more problems than the original depression/ illness itself!!!
    If thes edrugs are so great,, then why do they often list 'suicidal thoughts' and sometimes 'depression' as a side effect..?? How ironic.

    I myself experienced brain shivers since several years ago, I tried Zoloft (huge waste of money)- then Effexor... just to try out the 'new' meds to see what they were really all about (when going through a bout of depression/existential crisis)... but I searched and searched for evidence that this drug was NOT a crutch-- but something that would make your brain chemicals 'right again' so you could stop taking it. I found none. The thought of becoming dependent on it, and having the pill make your brain chemistry weaker and therefore MORE dependent on it,, seems like a frightening vicious cycle to me.. especially considering the possibility that some may change your brain chemistry permanently. Anyway the brain shivers are truly horrible!! After that, I said forget it-- weaned off, and vowed to never spend a cent on those evil psych drugs again.

    Interesting what is being said about PPD and copper. I always believed that most issues can be solved through better nutrition, good therapy, exercise, less stress, better sleep, a change in environment, hormonal testing, etc... and yet it seems SO little research is being done on these things & how they effect people. And actually,, it also seems very little research is being done on the psych drugs too! And yet the companies have no problem spending billions of dollars (probably) on ADVERTISING. What does that tell you?? They really are high-paid drug pushers. Didn't our mothers tell us,, 'Never take candy from strangers'..???

    On those forums, there was also a lot of talk of 'serotonin overload'.. which seems to be the exact opposite effect of what the pill is trying to achieve (or rather, it's the pendulum swinging too far the other way). I just thing that when you start messing with your brain with pills,, and you don't really know what it's doing.. it can be a very dangerous thing.

  7. #7
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    OK, next question- what medications do work?

    Are there any generally safe and effective anti-depressants on the market?
    What are your thoughts on this?

    BTW, it's not just anti-depressants which are in the current FDA queue of FUBAR.

    I am one of the people caught up in the Zetia/ Vytorin mess. I have to call my doctor Monday. I refuse to take Zetia after studies have finally been released showing that it causes more, not less plaque buildup in coronary arteries. For some reason, I didn't trust it from the beginning.. I did trust Zocor, as it controlled my genetically high cholesterol without side effects.

    I have an idea!
    Why don't we all just go to China and take their medications? They've killed our dogs with melamine byproducts and poisoned our children with lead in 2007, but at this point, I think our USA's FDA is screwed up just as badly, if not worse and just as financially corrupt!!!

    The FDA studies are supposed to be independent, double blind studies of new drugs submitted for marketing. They aren't SUPPOSED to take the drug manufacturer's word for the miracle cures.
    I think it's all about money and greed too.

    In another and opposite example, the FDA disallowed the licensing and prescribing of a very effective diet pill used for years in Europe in 2007. I am convinced that the reason is because all the over the counter snake oil diet crap, the money spent on Alli promotion, and the overall revenue generated by lap band procedures, bariatric surgery and the overall diet market in this country.
    There was very little contraindication for the drug they didn't approve except the amount of money we spend to try to lose weight vs. taking 1 effective pill per day.


    "Acquiring a pet may be the only opportunity a human has to choose a relative".

    This is MY truth, and this is my new baby puppy, Beau Monde.
    He will be joined in July by a tiny playmate.
    Please spay and neuter your dogs and cats.

  8. #8
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    Our society is about instant gratification-people go to the dr's looking for a pill to cure their ills because that is how they have been raised. Antibiotics instead of rest and fluids springs to mind....so we have in place a board that is responsible for matching the need for the panacea with the research to prove that the meds are effective. It is a simple case of the fox running the henhouse-take a look at the people who make up the FDA.

    Beyond the need to study the brain, we need to understand how people are different as well as how we are the same. Remember that little thing called DnA? There is a reason why Reb's dna is exclusive to reb and Believe's is exclusive to believe. All of the people on the forum want to know why the meds don't work for them when they worked for "my friend Sally." I know a cutting edge Dr. who deals with PPD and her standard question is what meds are your family members on and are they working? Makes sense right-if some brains are wired genetically to have episodes of depression, let's cut to the chase and see what drugs are working for people biologically related to you. Even better, if your mom had PPD and you have PPD, let's check and see how your hormones are/are not working. 'Bout friggin time, IMO.

    I recently did a forced wean from Topamax, which I was taking for migraines. (Couldn't afford to fill it-long story.) I was experiencing debilitating migraines 2 a month, non hormone related. I started experiencing them 2 a week once I cam off the Topamax-sucks to be me. I had no interest in getting back on something or taking a narcotic, but I have to function as a single parent. I did some research-I now take one capsule of Feverfew/White Willow Bark daily. Nary a migraine in 2 months...even with the worst sinus infection of my life right now plus pneumonia. I would like to thank the Good Lord Up Above for the internet and homeopathic healing which led me to this solution. It works for me-but it might not work for you...

  9. #9
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    seeking jana- i agree... i am very discouraged and disgusted with our system as well. doesn't seem much better than china at this point,, does it??

    believe-- that is fantastic that you got relief from something as simple as feverfew/white willow!! i always thought there must be something to a lot of herbal remedies, if they have been used by native americans, and sometimes even back to the stone age.. (i was reading up on elderberry (in the form of sambucol) recently,, after it helped my bf overcome a bout of the flu... supposedly there's evidence it was used medicinally all the way back to the stone age) the problem is.. when the stupid drug & big vitamin companies get their mits on stuff, they want to push everything as a 'miracle drug' and they oversell it like crazy.... but nonetheless.... i will only see a doctor if they are holistic. meaning of course they are open to ANY remedy- herbal, homeo, supplements, massage, chiro, and drugs or surgery only if needed (as a last resort).

    anyway i hope this solution keeps working for you, migraines are the worst-- i used to have 'em but i think they were hormonal and weather (barometric pressure)-related.. sometimes diet too.. but i have eliminated somethings that caused them, and the rest, i apparently grew out of.. thank god!

  10. #10
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    Quote Originally Posted by reb View Post
    csds-- THANKS for posting this. This makes my day!!! I've been saying this for YEARS. Maybe if some drugs help some people somewhere.. that whatever works for them, that's a good thing. (even if it may be the placebo effect).
    However.. the pharm companies rule the media.. and it does not surprise me that any research showing that antidepressants don't work very well, got shelved. IN fact I always kind of suspected this. And yet, they have those nice little explanations, with the little drawings or videos of the neurotransmitters crossing the synapse, and how in the depressed person the next cell gobbles them all up,, and how with the SSRIs, it leaves many of the neurotransmitters in the synapse, therefore making them more usable... and so on. But does anyone REALLY know what the pills are doing to your brain??
    It always amazed me how we have diagnostic machines to figure out what's wrong with our cars.. and yet.. we do not have diagnostic machines to figure out exactly what's wrong with our brains.. even though we surely have the technology.... WHY is this....???
    Instead, we have docs prescribing pills and getting kickbacks from companies to do so.. and they are truly groping in the dark, when it comes to what is going on in our brains!!!

    When you look at online forums, you will see thousands of desperate, frustrated souls pleading about how their pill worked for a short time and why did it stop working? ..and how they switch to another, then another, then another,, and nothing works.. and they are almost ALL screaming about the horrible side effects..... I remember on such forum... it may be gone now... but my point is,, this is only the tip of the iceberg.
    I do believe these pharm companies are criminally negligent and I despise the way they advertise so heavily making people believe this is the answer to your problems.... and how docs get people addicted to them for the rest of their lives (in many cases).... and you have people dealing with other symptoms and withdrawal issues that cause more problems than the original depression/ illness itself!!!
    If thes edrugs are so great,, then why do they often list 'suicidal thoughts' and sometimes 'depression' as a side effect..?? How ironic.

    I myself experienced brain shivers since several years ago, I tried Zoloft (huge waste of money)- then Effexor... just to try out the 'new' meds to see what they were really all about (when going through a bout of depression/existential crisis)... but I searched and searched for evidence that this drug was NOT a crutch-- but something that would make your brain chemicals 'right again' so you could stop taking it. I found none. The thought of becoming dependent on it, and having the pill make your brain chemistry weaker and therefore MORE dependent on it,, seems like a frightening vicious cycle to me.. especially considering the possibility that some may change your brain chemistry permanently. Anyway the brain shivers are truly horrible!! After that, I said forget it-- weaned off, and vowed to never spend a cent on those evil psych drugs again.

    Interesting what is being said about PPD and copper. I always believed that most issues can be solved through better nutrition, good therapy, exercise, less stress, better sleep, a change in environment, hormonal testing, etc... and yet it seems SO little research is being done on these things & how they effect people. And actually,, it also seems very little research is being done on the psych drugs too! And yet the companies have no problem spending billions of dollars (probably) on ADVERTISING. What does that tell you?? They really are high-paid drug pushers. Didn't our mothers tell us,, 'Never take candy from strangers'..???

    On those forums, there was also a lot of talk of 'serotonin overload'.. which seems to be the exact opposite effect of what the pill is trying to achieve (or rather, it's the pendulum swinging too far the other way). I just thing that when you start messing with your brain with pills,, and you don't really know what it's doing.. it can be a very dangerous thing.
    we do not have diagnostic machines to figure out exactly what's wrong with our brains.. even though we surely have the technology

    You and I can get the Nobel; just tell me where that technology is.

    docs prescribing pills and getting kickbacks from companies to do so

    Left me out of that one too. Nary a "kickback" to me.

    Psychoactive drugs are a whole new frontier just being explored. Having the big pharmas drive this exploration isn't in the best interest of all patients. They sit on data showing unacceptable side effects or lack of efficacy; this makes prescribers as furious as it does you. You may see yourself and those you know as your model for how effective these drugs may be. The power of large studies is to see beyond that small, personal purview. However, not publishing negative data makes informed choices by docs very difficult, and I'd like to see a lot more deep digging about why this isn't published, especially in the refereed journals who are touted to have little bias.

    If you really think there are no docs who look out for your best interests, or we all wake up every day thinking how we can mistreat you and pull some coin at the same time, simply don't go to any of us. Ever. All you're doing is taking the place of someone who really wants our help. Without question, we improve people's lives every day, but the system is far from perfected and we need thoughtful help from people who have not had optimal experiences to make it better, more affordable, and more available. I take home a lot of useful advice from most posters here, but not from absurd ad hominem attacks.


    Crypto6


  11. #11
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    crypto-- i'd like you to show me where i said that 'no docs ever do anyone any good' and 'they wake up every day thinking of new ways to harm us'.
    almost every day,, i am praising the benefits or GOOD docs and psychiatrists and recommending to people that they seek one out if they need help.

    talk about an ad hominem attack....!!?

    sorry.. but people/patients/consumers have been grossly abused and taken advantage of for generations... (myself included),, and it's about time we have a voice and stand up for ourselves. i am ever grateful for good doctors of all kinds who are not just drug pushers-- but we also need to demand respect and truthful answers too- and we must refuse to be anyone's guinea pigs for profit....!!!

  12. #12
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    by the way.. the definition of ad hominem 'consists of replying to an argument or factual claim by attacking or appealing to a characteristic or belief of the person making the argument or claim, rather than by addressing the substance of the argument or producing evidence against the claim'..

    and excuse me,, but i (and millions of others) have PLENTY of evidence. and i WAS addressing the 'substance of the argument'. i was not just attacking doctors & pharm companies for the sake of attacking doctors & pharm companies.. i was attacking the lies and fraudulent practices that many of them are involved in.

  13. #13
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    Quote Originally Posted by reb View Post
    by the way.. the definition of ad hominem 'consists of replying to an argument or factual claim by attacking or appealing to a characteristic or belief of the person making the argument or claim, rather than by addressing the substance of the argument or producing evidence against the claim'..

    and excuse me,, but i (and millions of others) have PLENTY of evidence. and i WAS addressing the 'substance of the argument'. i was not just attacking doctors & pharm companies for the sake of attacking doctors & pharm companies.. i was attacking the lies and fraudulent practices that many of them are involved in.
    Very few docs are involved in kickbacks or other forms of fraud, and we want them out of medicine and in jail more than you do because they disgrace what we have devoted our lives to. Big pharma needs a complete purging; how this can happen, I don't know. I trust very little of what they say and have to research all claims. The reason this article is so troubling is that the journals I use to do the research are now called into question. This is a landmark article identifying a very big problem. We'll hear more about this, and soon I hope.

    Crypto6

  14. #14
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    Good doctors, a bad doctor, the FDA's role as overseer for all Rx drugs

    I've only seen one doctor who ' courted' the drug companies to excess. He was my primary care physician for a couple of years. I got tired of seeing the cute little female drug reps going in his office loaded down with samples and puny little branded giveaways for the staff while I had to wait and wait and wait to see him. Then, this doctor started giving me bags full of samples of the latest, most promoted meds for things I really didn't have serious problems with.

    I went in for a tetanus booster because of a backyard puncture wound- I walked out with 2 new antibiotic samples, one of which is no longer on the market in oral form because of severe potential side effects.

    I mentioned that I thought my Zocor was causing insomnia.I walked out with a month's worth of Ambien CR in his drug-branded plastic bags. My Zocor dose was never addressed.

    I eventually threw his samples away, reported him to the state medical board and my insurance company, and found a wonderful doctor. I had to find the doctor, because it is my responsibility.
    Unfortunately, the medical board in my state had no jurisdiction over what kind or amount of samples a doctor hands a patient. The unscrupulous doctor now has a multi-million dollar waterfront mansion and a brand new office complex. He is one bad doctor among countless good ones, but he has high visibility as a bad example of a physician.

    Extremely dedicated and talented doctors and their associated hospital teams have saved my life several times. I bet most posters here can think of a time when either their life or a family member's life is due to expert medical care.
    How can a person put a value on excellent care? It's invaluable.
    IF I had been suspicious of doctors in general and had delayed seeking treatment on at least 2 occasions, I would have surely died. Both occurrances involved very rare emergency situations which weren't easy to find. In other words, I didn't feel that bad, but I thought I should see my doctor just in case. Herbs or homeopathy wouldn't have worked. I would have been dead as a doornail in the absence of prompt, accurate diagnosis and treatment by a team of doctors, nurses, and other hospital staff. One of the most vital relationships we form is vital to our very survival and it is with our primary care physician. I would be terrified to go through life without having a doctor who knows me, knows my medical history and can take good care of me during illness or injury, as well as provide annual wellness care.

    If the train of thought that drug companies rule over most doctors held true, the basic premise behind this fallacy is that most doctors are greedy and weak.
    This is insulting. Placing the blame for the FDA's shortcomings onto doctors in general is misplacement of the blame, from what I know of the FDA's mandated role in approving ALL prescription drugs.

    Last and most importantly to me:
    One of the most important people in my personal life happened to be a physician, board certified in Internal Medicine. We 'dated' over a period of months that stretched into years. He was either on call, staying late at the hospital to monitor critically ill patients, or making our date only to fall asleep out of absolute exhaustion more times than I could count. I understood, and had great empathy for both his patients who needed him so much, and for his limited personal time. He showed me exactly what being a doctor means. We belonged together- only his time didn't stretch past 24 hours in a day.
    When his practice hours had finally slowed down enough ( with the help of 2 partners ) for us to talk seriously about marriage, he was diagnosed with cancer and died less than a year later. He literally worked himself to death at a young age. A fine man who devoted his life to helping others simply ran out of time for himself.

    Like you, I am extremely concerned about the implications and possible ramifications of the Yahoo study. I want to know more about the studies, and more about how and why SSRIs and SSRNIs have become so widely accepted, prescribed, and ingested by our populace.
    If they are as ineffective as the Yahoo report suggests, then I hold the FDA responsible for green lighting the drugs in the first place, not the pharmaceutical companies who formulated them.

    I know exactly what my dear doctor friend would say about this breaking news regarding SSRIs and SSRNIs, if he was still alive to see it: He would say that no drug has ever been proven to effectively treat severe depression and that the Prozac nation should have seen this coming for a long time.
    He would most likely also tell me that inpatient mental health treatment center programs need revitalization to provide the level of care for at least 30 days per patient which they offered before managed care cut their budgets so severely that they have become emergency holding areas only.
    I strongly believe, from personal experience, that there is no magic bullet to 'cure' the disorder of depression severe enough to require medical intervention.

    Quote Originally Posted by crypto6 View Post
    Very few docs are involved in kickbacks or other forms of fraud, and we want them out of medicine and in jail more than you do because they disgrace what we have devoted our lives to. Big pharma needs a complete purging; how this can happen, I don't know. I trust very little of what they say and have to research all claims. The reason this article is so troubling is that the journals I use to do the research are now called into question. This is a landmark article identifying a very big problem. We'll hear more about this, and soon I hope.

    Crypto6


    "Acquiring a pet may be the only opportunity a human has to choose a relative".

    This is MY truth, and this is my new baby puppy, Beau Monde.
    He will be joined in July by a tiny playmate.
    Please spay and neuter your dogs and cats.

  15. #15
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    I think anti-depressant drugs work or Psychiatrists would not keep prescribing them - it would be obvious they were not working. Doctors do NOT receive kickbacks from drug companies.

    Antidepressants are safer than many drugs, as they just affect the action of the neurotransmitters, like serotonin or norepinephrin - they don't make metabolic changes and don't have the dry-mouth, drowsiness type side effects the old types used to.

    The problem is I think they are overprescribed, and too many family doctors prescribe them. They won't fix everything - you may still need psychotherapy, exercise, a divorce (or not); new job, work through whatever issues are causing the depression

    As the article said, it's difficult to do studies on antidepressants; because you can't do an exact measurement of whether it helped - like with a hypertensive drug (measuring the blood pressure), or statin drug (measure the cholesteral)

    You can only rely on the patient's feelings or whether they seem better or not; and in the control group can quickly figure out whether they are on the placebo or the anti-depressant or new drug.

    Still, it seems doctors need access to all the relevant studies. And drug reps DO influence some doctors to prescribe certain, maybe more expensive drugs over other, less well known ones IMO.

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