Depression Breakthrough: A Proven "Better Than Drugs" Solution with Positive Side Effects

Posted By Dr. Mercola | October 06 2010 | 192,425 views Share3609 Previous Article Next Article Total Video Length: 54:26

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Here, medical journalist and Pulitzer Prize nominee Whitaker discusses how the widespread use of psychiatric drugs has contributed to the increase in mental illness.

Tens of millions of Americans have been made crazy — due to their use of or withdrawal from psychiatric drugs. That’s the conclusion of two books written by award-winning health science writer Whitaker.

In his first book, Mad in America: Bad Science, Bad Medicine and the Enduring Mistreatment of the Mentally Ill, Whitaker explained the history of the treatment of those with severe mental illness, and the 600 percent increase in the disabilities of psychiatric drug-takers.

His latest book, Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, documents the powerful forces behind psychopharmacology, and follows the money behind those forces.

Dr. Gary Kohls, reviewing the books in the Online Journal, notes:

“Psychiatric drugs, whose developers, marketers and salespersons are all in the employ of the giant drug companies, are far more dangerous than the drug and psychiatric industries are willing to admit: These drugs, it turns out, are fully capable of disabling — often permanently — body, brain and spirit.”

Sources:

  Online Journal August 26, 2010

  Video Transcript

Dr. Mercola's Comments:

Depression used to have a very good outcome. If you came to your physician with symptoms of depression 40 or even 30 years ago, he would tell you that you could and would get better. You’d be assured that most depressive episodes run their course and terminate with virtually complete recovery, without specific interventions such as drug treatment.

But as Whitaker points out in his books, something changed in the field of diagnosing and treating depression in the last few decades, and that something has led to a 600 percent increase in persons on government (Social Security) disability due to mental illness!

Today’s Approach to Mental Health = Drugs

So what happened between 1974 and today to make the prognosis of depression go from one with a positive outcome to one that essentially disables you for life?

You don’t need a medical degree to figure it out.

Just turn on your TV, and what do you see?

Advertisements that all but hypnotize you into believing that this drug or that will help you feel better – especially if it turns out that you’re one of the two-thirds of people on antidepressants who aren’t getting better.

As Whitaker points out in his interview with me, that’s the Abilify ad, which basically is telling you to step up onto the next rung on the psychiatric drug ladder and add an antipsychotic drug, because what they’re giving you on the lower rung – antidepressants – don’t work.

In his research, Whitaker has conclusively shown that in most cases these drugs work no better than a placebo – and can also have serious side effects, including causing even more serious mental disorders than the one you’re being treated for!

I’ve discussed this in previous articles, such as this one in 2002. And earlier this month, I wrote about how drug companies have hidden clinical trials that showed negative effects, or no efficacy at all, as Whitaker describes in his work.

When it comes to side effects, many people are aware of the most common ones, such as sexual dysfunction and sleeplessness. And if you go back to the TV, you’ll see that some of these negative effects are mentioned in the ads – albeit so quickly you don’t really have time to think about them.

But did you know that some of the worst side effects aren’t even classified as such?

Or that others, like substantial weight gain and increased glucose and lipid metabolism, can be so unpleasant that people on these drugs just stop taking them?

A Terrible Side Effect They Don’t Publicize

In fact, a 2005 study in the New England Journal of Medicine reported that 74 percent of schizophrenic patients in one study quit taking their medication either because of its inefficacy (it didn’t work); or because it had intolerable side effects, or other unwanted problems.

Another factor that is rarely discussed is the potent addictive potential of these drugs.

And perhaps the worst “side effect” of all is that they can cause you to acquire a more severe form of mental illness than you started with!

That’s right – as Whitaker found during his thousands of hours of research on the topic – after what might be an initial uplift in your condition, antidepressant drug users tend to spiral downward into a chronic course of long-term depression.

You can also end up becoming bipolar, or developing various types of psychoses, meaning that you’ll need to “graduate” to a new or additional medication, often an anti-psychotic drug that blocks dopamine receptors in your brain.

The cyclic effect of these drugs causing the very problems they were designed to cure is something Whitaker discusses in-depth in his book.

The Money Behind the Madness

As a result of this vicious cycle, where the drugs deepen the mental health problems they’re designed to treat. Spending on psychiatric drugs has risen from about $600 million a year in 1985, to more than $40 billion a year today, while disability rates due to depression and bipolar illness have skyrocketed!

Not exactly what you would expect to find if these drugs were actually working as advertised.

How we came to this point is a story in itself, which Whitaker has explored at depth and relates with finesse.

I urge you to read both his books (Mad in America, and Anatomy of an Epidemic) to get the full story, but in short, he explains it like this: In the 1970s psychiatry as a discipline was under siege, with lots of therapists entering the field. To make matters worse, an old stand-by anxiety drug was beginning to be deemed too addictive and harmful to use.

Because of this, sales of psychiatric drugs had dropped. As a result, psychiatry did a sort of gathering of the troops, and decided that one way to save the industry as well as their jobs was to rewrite their job descriptions and the field of psychiatry itself.

This led to the creation of a new diagnostic manual, in which the definitions of mood problems such depression suddenly changed to medical disorders – thus diagnosable only by a physician or psychiatrist, and treatable by prescriptions that only those physicians/psychiatrists could write.

To sell this new idea to the public, the American Psychiatric Association (APA) decided to align itself with none other than the very pharmaceutical companies that had a financial stake in this new paradigm – and the rest, as they say, is history.

Big Pharma moved in, sponsoring so-called scientific presentations, hiring academic physicians and people major medical schools to do their sales talks, and sending the money flowing through academic grants, fellowships, and funding of studies -- all designed to “help” your mental health with the aid of their drugs.

And now, in a sad reflection of the old adage, “He who pays the piper calls the tune,” psychiatry is a vicious circle of diagnosis, drugs, and more drugs as one illness leads to the next.

The bottom line is that the real cause of the explosion in mental illness is, first, the money behind the medications, and second, a flawed system that depends on drugs that merely transforms one problem into another.

Exercise: One of Nature’s Best Alternatives to Maintaining Good Mental Health

Fortunately, more and more research is coming out in support of natural, drug-free ways to maintain or achieve good mental health. Much of that research is showing that simple strategies such as dietary changes and physical activity can significantly assist your recovery.

For example:

A Duke University team studied three groups that tried exercise only; exercise plus drugs; and drugs only, to see what treatment best treated depression. They found that after six weeks, the drug-only group was doing a tiny bit better than the other two groups.

They hypothesized that the best stay-well rate would be those with drugs plus exercise.

But they were wrong!

Ten months later, it was the exercise-only group that was most successful in maintaining wellness! In fact, according to a September 22, 2000 Duke University press release:

“After demonstrating that 30 minutes of brisk exercise three times a week is just as effective as drug therapy in relieving the symptoms of major depression in the short term, medical center researchers have now shown that continued exercise greatly reduces the chances of the depression returning.

The new study, which followed the same participants for an additional six months, found that patients who continued to exercise after completing the initial trial were much less likely to see their depression return than the other patients.

Only 8 percent of patients in the exercise group had their depression return, while 38 percent of the drug-only group and 31 percent of the exercise-plus-drug group relapsed.”

While the researchers weren’t exactly sure why exercise worked better than the drug used in this study – Zoloft – they speculated that active participation in their get-well program was the key difference for the exercise-only group.

"Simply taking a pill is very passive," said study leader James Blumenthal. "Patients who exercised may have felt a greater sense of mastery over their condition and gained a greater sense of accomplishment. They may have felt more self-confident and competent because they were able to do it themselves, and attributed their improvement to their ability to exercise.

“Findings from these studies indicate that a modest exercise program is an effective and robust treatment for patients with major depression. And if these motivated patients continue with their exercise, they have a much better chance of not seeing their depression return.”

That’s right: In this study of 156 participants diagnosed with major depressive disorder, the researchers found that the best drug of all was the feeling that they were actively in control of determining their own outcomes!

The Duke researchers were not exercise specialists and it is likely that they overlooked exercises that work your white muscle fibers, like the Peak Fitness Techniques, which could work even better.

Yoga – A Gentle Way to Exercise Depression

Yoga is another proven way to address depression and avoid medications. Recent research confirms that yoga not only enhances mood, and has positive effects over other physical activities, but also helps increase brain gamma aminobutyric (GABA) levels.

In this study, participants who practiced yoga three times a week for an hour increased brain gamma aminobutyric (GABA) levels over another group that walked three times a week for an hour.

A similar study in 2007 reported the same thing, leading researchers to believe that the practice of yoga could be an alternative treatment for depression and anxiety, disorders associated with low GABA levels.

If you’ve followed my articles even a little while, you also know that EFT, or the Emotional Freedom Technique, is an exercise involving only your fingers and mind that I highly recommend for optimizing emotional health. Based on the same energy meridians used in traditional acupuncture to treat physical and emotional ailments for over 5,000 years, this technique works without needles, while using positive affirmations.

Nutrition Also Plays an Important Part

As Whitaker and I discuss in this interview, nutrition is another key player in evidence-based alternatives to drugs.

It’s already known that many additives, preservatives and food colorants can cause behavioral changes, and sugar should definitely be on this list as well.

One of the most recent and highly plausible theories that explain sugar’s impact on your mood and mental health is the connection between sugar and chronic inflammation.

Other studies have also found significant links between high-sugar diets and mental health problems such as depression and schizophrenia, even though they were not focused on the presence of inflammation per se.

For example, a 2004 study published in the British Journal of Psychiatry found that a higher dietary intake of refined sugar and dairy products predicted a worse 2-year outcome of schizophrenia.

As explained by Dr. Russell Blaylock, high sugar content and starchy carbohydrates lead to excessive insulin release, which can lead to falling blood sugar levels, or hypoglycemia. Hypoglycemia, in turn, causes your brain to secrete glutamate in levels that can cause agitation, depression, anger, anxiety, panic attacks and an increase in suicide risk.

The dietary answer for treating depression is to severely limit sugars, especially fructose, as well as grains.

The Importance of Omega-3 Fats for a Healthy Mind

Studies also show that omega-3 fats may positively influence outcome in depressive disorders. Low plasma concentrations of DHA (a type of omega-3 fat) is associated with low concentrations of brain serotonin. This decreased amount of serotonin can be associated with depression and suicide.

Not getting enough animal based omega-3 fats is known to change the levels and functioning of both serotonin and dopamine (which plays a role in feelings of pleasure), as well as compromise the blood-brain barrier, which normally protects your brain from unwanted matter gaining access.

Omega-3 deficiency can also decrease normal blood flow to your brain, an interesting finding given that studies show people with depression have compromised blood flow to a number of brain regions.

Finally, omega-3 deficiency also causes a 35 percent reduction in brain phosphatidylserine (PS) levels, which is relevant considering that PS has documented antidepressant activity in humans.

Omega-3 fats such as those in krill oil have actually been found to work just as well as antidepressants in preventing the signs of depression, but without any of the side effects. In fact, throughout my years of medical practice I’ve had large numbers of patients be able to stop their antidepressants once they started taking omega-3 fats.

So if you are currently struggling with depression, taking a high-quality, animal-based omega-3 fat supplement daily is a simple and smart choice … but it is only one important part of my overall recommendations for treating depression.

How the Sun Can Influence a “Sunnier Disposition”

Another essential nutrient in the treatment of depression is vitamin D.

One study found people with the lowest levels of vitamin D were 11 times more prone to be depressed than those who received healthy doses.

And, according to a study published in the September 9, 2010 issue of the Archives of General Psychiatry, maintaining proper levels of vitamin D, and particularly Vitamin D3, in utero and during early infancy can even help prevent a much more serious mental disorder – schizophrenia.

The study showed that newborn babies born with low vitamin D levels were more likely to develop schizophrenia later in life – leading researchers to suggest that perhaps vitamin D supplements might be all you need to prevent this devastating illness.

The researchers also looked at other populations, such as dark-skinned ethnic groups living in cold countries, and residents of highly urban areas who aren’t exposed to regular sunlight like those in rural areas, concluding that:

“It may be feasible to reduce the incidence of schizophrenia in this group by a staggering 87 percent” by simply giving them Vitamin D supplements!

I strongly recommend optimizing your vitamin D levels, either by sunlight exposure, a safe tanning bed, or taking a high-quality vitamin D supplement, to your list of depression fighters.

Salt is Also a Natural Antidepressant…

Interestingly, simple sodium deficiency also creates many symptoms that are nearly identical to those of major depression, such as:

loss of appetite loss of capacity to experience pleasure and joy difficulty concentrating excessive fatigue general sense of exhaustion

To learn more about the importance of natural salt for optimal brain function and mood regulation, please see my previous article Is Salt Nature's Antidepressant?

What To Do if You’re Already on Medication for Depression

If you’ve already been diagnosed with depression or a more serious mental illness, it is vitally important you do NOT stop your medication cold-turkey! Doing so could be dangerous to both your mental and physical health.

What you want is a cautious approach to discontinuing these drugs – and you need to do this with the assistance of a qualified and knowledgeable clinician who can slowly wean you off them over a period of a few weeks or months.

Ideally, this would be someone who has roots in natural health, and who will help you use natural, healthy options such as dietary changes, exercise, and some energy psychology approaches to do this.

Having a professional help you also means you’ll have a mentor who will guide you through the physical and emotional changes you’ll experience as you leave the drugs behind, including any uncomfortable withdrawal symptoms.

Mental Health is Often Inseparable from Physical Health

I want to reiterate that depression can indeed be a very serious condition. If left untreated it can have a devastating impact on just about every aspect of your life and can actually kill you by leading to suicide.

However drugs are very rarely the answer.

So please actively investigate and use the natural treatments I’ve suggested the above, ideally with the support and guidance of a knowledgeable natural health care practitioner.

Always remember that these three primary factors -- exercise, addressing emotional stress, and eating right -- will make you feel at the top of your game. Whether you want to overcome depression, feel happier or just want to stay healthy, these are the lifestyle changes that will get you there.

Related Links:

  The Most Effective Treatment for Depression Isn’t Drugs – But You’ll Never Hear that from Your Psychiatrist

  Best-Kept Secret for Treating Depression

  Treatment Options for Treating Depression

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http://psychrights.org/pr/101015AttyFeeMotionNR.pdf

NEWS RELEASE

FOR IMMEDIATE RELEASE                                                                                      CONTACT

October 15, 2010                                                                                                        Jim Gottstein

                                                                                                                       begin_of_the_skype_highlighting              907-274-7686      end_of_the_skype_highlighting907-274-7686

                                                                                             This email address is being protected from spambots. You need JavaScript enabled to view it.

Medicaid Fraud Defendants Seek Almost $325,000 in Legal Fees and Costs After Court Dismissed Case Because PsychRights is Not In It for The Money

On October 14, 2010, Osamu Matsutani, Providence Hospital, Anchorage Community Mental Health Services and other defendants in U.S. ex rel PsychRights v. Matsutani et al., filed for almost $325,000 in legal fees and costs against the Law Project for Psychiatric Rights (PsychRights®).  This was in the wake of the case's dismissal in late September on the grounds that government officials already know about the industry-wide fraud and are allowing it to continue.  In that decision, the district decided the case could not go forward because,

the Government already "has pursued False Claims Act cases and achieved extremely large recoveries against drug companies for causing the presentment of claims to Medicaid for prescriptions of psychotropic drugs that are not for medically accepted indications, including Geodon and Seroquel for use in children and youth." Thus, . . . the Government already knows about the conduct . . . . [1]

That decision is on appeal.  

A primary reason why these defendants assert they should be paid their attorney's fees is because PsychRights is bringing these cases to protect children and youth from the massive harm caused by these drugs, rather than for the money.  Jim Gottstein, the president of PsychRights, said PsychRights will oppose the attorney's fees and costs requests.

#  #  #

The Law Project for Psychiatric Rights is a public interest law firm devoted to the defense of people facing the horrors of forced psychiatric drugging and electroshock.  PsychRights is further dedicated to exposing the truth about psychiatric interventions and the courts being misled into ordering people subjected to these brain and body damaging drugs and electroshock against their will.  Due to massive growth in psychiatric drugging of children and youth and the current targeting of them for even more psychiatric drugging, PsychRights has made attacking this problem a priority.   It is an unfolding national tragedy of immense proportions. Extensive information about the tragic damage caused psychiatric drugs and electroshock is available on the PsychRights web site: http://psychrights.org/.

______________[1] Page 21 in Docket No. 163, United States ex rel Law Project for Psychiatric Rights v. Matsutani et.al, No. 3:09-cv-80.

Robert Whitaker on MFI Live Web Free Radio: Why are discussions about psychiatric drug controversies so often silenced?

— filed under:

On Saturday, 9 October 2010, MFI held a live, free Internet show with special guest author Robert Whitaker, and you can hear the archive. The US government has funded an annual meeting of mental health consumers and psychiatric survivors for the past 25 years. But when their conference organizers decided to address controversies involving psychiatric drugs, the federal funders stepped in to intervene. Here's your gateway to the debate. [Updated 11 Oct. 2010]

More than 1,000 mental health consumers and psychiatric survivors registered for Alternatives 2010, and heard Whitaker speak.

updated 11 Oct. 2010

 

    On MindFreedom Live Free Web Radio

 

    Robert Whitaker was special guest:

    Saturday, 9 October 2010 -- 2 pm to 3 pm ET USA

    Live Call-in Show on "Psychiatric Drugs, Silence and Free Speech."

Listen to archive of this and other MFI web radio shows here:    http://www.blogtalkradio.com/davidwoaks

This was an open call-in show about psychiatric drugs, and how too many agencies want to SILENCE discussion about their hazards and controversies.Host David Oaks, director of MindFreedom International, just returned from the Alternatives 2010 conference of 1,000 mental health consumers and psychiatric survivors. Hear his report about free speech and the mental health system.Find out the latest about how the federal government tried to control the message of author Robert Whitaker at the conference.You can listen to the archive, by clicking here:    www.blogtalkradio.com/davidwoaks~~~~~~~~~~Background info on the topic of psychiatric drugs, silence and free speech:Author Robert Whitaker blogs on Psychology Today about whether or not US federal pressure to silence discussions on psychiatric drugs, you can join the discussion:http://www.psychologytoday.com/node/48811Report on MindFreedom successful campaign to support Whitaker speaking:http://3.ly/whitakervictoryMFI director David Oaks blogs about Alternatives 2010:http://www.mindfreedom.org/mfi-blogPsychologist/Author Bruce Levine blogs on Huffington Post defending Alternatives 2010... you can still comment:http://3.ly/levinejaffe

Levine was responding to another HuffPost blogger, D. J. Jaffe, who attacked funding for Alternatives 2010, you can read about that here:http://www.mindfreedom.org/kb/media-issues/huffington-post-mental-health

MindFreedom's Facebook page also has a discussion on controversy:http://www.facebook.com/pages/MindFreedom-International/33579368821Mental health consumer and psychiatric survivor leaders called it back in July, when they issued a statement at a SAMHSA summit, warning about "undue influence of the pharamceutical industry" in mental health care. Your group is encouraged to endorse the urgent call:http://www.mindfreedom.org/kb/psychiatric-drugs/bastille-2010~~~~~~~~~~~~Don't wait for corporate media to change the mental health system.UNITED. INDEPENDENT. ACTIVISM.Join or renew your membership in MindFreedom International now!    http://www.mindfreedom.org/join-donate~~~~~~~~~~~~If you did NOT receive this public news alert directly from the mindfreedom-news public e-mail alert system, please add your e-mail address to this free no-spam service, which does not require membership:http://www.intenex.net/lists/listinfo/mindfreedom-news

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http://www.guardian.co.uk/commentisfree/cifamerica/2010/oct/12/why-genes-are-leftwing

Why genes are leftwing

The right loves genetic explanations for poverty or mental illness. But science fingers society

When the map of the human genome was presented to the world in 2001, psychiatrists had high hopes for it. Itemising all our genes would surely provide molecular evidence that the main cause of mental illness was genetic – something psychiatrists had long believed. Drug companies were wetting their lips at the prospect of massive profits from unique potions for every idiosyncrasy.

But a decade later, unnoticed by the media, the human genome project has not delivered what the psychiatrists hoped: we now know that genes play little part in why one sibling, social class or ethnic group is more likely to suffer mental health problems than another.

This result had been predicted by Craig Venter, one of the key researchers on the project. When the map was published, he said that because we only have about 25,000 genes psychological differences could not be much determined by them. "Our environments are critical," he concluded. And, after only a few years of extensive genome searching, even the most convinced geneticists began to publicly admit that there are no individual genes for the vast majority of mental health problems. In 2009 Professor Robert Plomin, a leading behavioural geneticist, wrote that the evidence had proved that "genetic effects are much smaller than previously considered: the largest effects account for only 1% of quantitative traits". However, he believed that all was not lost. Complex combinations of genes might hold the key. So far, this has not been shown, nor is it likely to be.

This February's editorial of the Journal of Child Psychology and Psychiatry was entitled "It's the environment, stupid!". The author, Edmund Sonuga-Barke, stated that "serious science is now more than ever focused on the power of the environment … all but the most dogged of genetic determinists have revised their view".

In Sonuga-Barke's own field, attention deficit hyperactivity disorder, he observed that "even the most comprehensive genome-wide scans available, with thousands of patients using hundreds of thousands of genetic markers … appear to account for a relatively small proportion of disorder expression". Genes hardly explained at all why some children have ADHD and not others.

That was illustrated recently in a heavily publicised study by Anita Thapar, of Cardiff University. Although she claimed to have proved that ADHD is a "genetic disease", if anything, she proved the opposite. Only 16% of the children with ADHD in her study had the pattern of genes that she claimed causes the illness. Taken at face value, her study proved that non-genetic factors cause it in 8 out of 10 children.

Another theory was that genes create vulnerabilities. For example, it was thought that people with a particular gene variant were more likely to become depressed if they were maltreated as children. This also now looks unlikely. An analysis of 14,250 people showed that those with the variant were not at greater risk of depression. Nor were they more likely to be depressed when the variant was combined with childhood maltreatment.

In developed nations, women and those on a low income are twice as likely to be depressed as men and the wealthy. When DNA is tested in large samples, neither women nor the poor are more likely to have the variant. Worldwide, depression is least common in south-east Asia. Yet a study of 29 nations found the variant to be commonest there – the degree to which a society is collectivist rather than individualistic partly explains depression rates, not genes.

Politics may be the reason why the media has so far failed to report the small role of genes. The political right believes that genes largely explain why the poor are poor, as well as twice as likely as the rich to be mentally ill. To them, the poor are genetic mud, sinking to the bottom of the genetic pool.

Writing in 2000, the political scientist Charles Murray made a rash prediction he may now regret. "The story of human nature, as revealed by genetics and neuroscience, will be conservative in its political [shape]." The American poor would turn out to have significantly different genes to the affluent: "This is not unimaginable. It is almost certainly true." Almost certainly false, more like.

Instead, the Human Genome Project is rapidly providing a scientific basis for the political left. Childhood maltreatment, economic inequality and excessive materialism seem the main determinants of mental illness. State-sponsored interventions, like reduced inequality, are the most likely solutions.

http://www.bmj.com/content/341/bmj.c5641.full BMJ 2010; 341:c5641 doi: 10.1136/bmj.c5641 (Published 12 October 2010) Cite this as: BMJ 2010; 341:c5641Editorial

Missing clinical trial data: setting the record straight

Fiona Godlee, editor1, Elizabeth Loder, associate editor1

+ Author Affiliations

1BMJ, London WC1H 9JR This email address is being protected from spambots. You need JavaScript enabled to view it.

Urgent action is needed to restore the integrity of the medical evidence base

Like us, you have probably grown accustomed to the steady stream of revelations about incomplete or suppressed information from clinical trials of drugs and medical devices.1 If so, this issue of the BMJ features a pair of papers that will dismay but not surprise you. Researchers for an official German drug assessment body charged with synthesising evidence on the antidepressant reboxetine encountered serious obstacles when they tried to get unpublished clinical trial information from the drug company that held the data, an experience from which they draw several lessons (doi:10.1136/bmj.c4942).2

Once they were able to integrate the astounding 74% of patient data that had previously been unpublished, their conclusion was damning: reboxetine is “overall an ineffective and potentially harmful antidepressant” (doi:10.1136/bmj.c4737).3 This conclusion starkly contradicts the findings of other recent systematic reviews and meta-analyses published by reputable journals.4 5 67 8 These studies presumably met prevailing standards for the conduct of meta-analyses. Yet we now know that they did not provide a properly balanced view of the harms and benefits of reboxetine. Why? Because they did not combine all of the existing evidence from clinical trials. Furthermore, the difficulties encountered by Wieseler and colleagues in obtaining the reboxetine data show that routine inquiries about missing information, which many authors of meta-analyses make, are probably insufficient.9 Instead dogged, even heroic, persistence is required, as the Cochrane reviewers trying to untangle the evidence for oseltamivir have found.10 11

Research that is conducted but not reported is only part of the problem. Steinbrook and Kassirer point to the rosiglitazone (Avandia) story as an example of problems arising from incomplete access of researchers and others to the raw data within a trial.12 Problems also arise, they say, with the way in which these data are interpreted or adjudicated. They call for journals and editors to do more, including reserving the right to inspect trial data themselves. This is a contentious topic. Commentator Chris Del Mar applauds this stand,13 but Nick Freemantle points out that although it is easy to call for unfettered access to data, it is another thing entirely to provide and make use of it.14

The reboxetine story and similar episodes must call into question the entire evidence synthesis enterprise. Meta-analyses are generally considered the best form of evidence, but is that a plausible world view any longer when so many of them are likely to be missing relevant information?15 Existing estimates of treatment benefits are not always altered when previously unpublished clinical trial data become available. At present, however, we do not know the extent to which integration of missing data would support or refute key portions of the existing evidence on which doctors, patients, and policy makers rely.

As Wieseler and colleagues point out, the Food and Drug Administration Amendments Act of 2007 and parallel European efforts will increase the accessibility of clinical trial results and make it more difficult to conceal information.2 But they do not solve the problem of our current evidence base, which contains incomplete and questionable evidence. So what can be done? At the moment there are no organised efforts to identify missing information and integrate it into the existing evidence base.

The BMJ has a particular interest in the impact of unpublished data on the overall verdict regarding the effectiveness of medical treatment. Because we think that it is important to re-evaluate the integrity of the existing base of research evidence, the BMJ will devote a special theme issue to this topic in late 2011. A detailed call for papers will follow, but we mention this now because we hope that researchers with such projects under way will feel encouraged. We also hope that other potential authors might begin now to plan suitable projects.

We are especially interested in high quality original research that aims to uncover previously unavailable data and re-evaluate treatments and practice in light of that new evidence. The ideal way to summarise the findings would be a formal meta-analysis, showing how the newly identified information affects the balance of benefit to harm. It is not necessary to conclude that full consideration of all of the evidence in fact changes practice—we will also be interested in papers that conclude that, even with new evidence, nothing should change.

Lost in the sometimes rancorous debate over research transparency, and the reasons for publication and non-publication, is the most important thing: efforts are needed to restore trust in existing evidence. To that end, the BMJ is more interested in constructive use of data than finger pointing or blame. We encourage drug companies and device manufacturers, as well as academic researchers, to take advantage of the opportunity afforded by our upcoming theme issue. Full information about previously conducted clinical trials involving drugs, devices, and other treatments is vital to clinical decision making.

It is time to demonstrate a shared commitment to set the record straight.

 

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Notes

Cite this as: BMJ 2010;341:c5641

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Footnotes

Research, doi:10.1136/bmj.c4737

Analysis, doi:10.1136/bmj.c4942

Analysis, doi:10.1136/bmj.c5391

Analysis, doi:10.1136/bmj.c5406

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Provenance and peer review: Commissioned; not externally peer reviewed.

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Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, Kaiser T, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ2010;341:c4737.

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