By Dr. Mercola
The antidepressant class of drugs known as selective serotonin reuptake inhibitors (SSRIs) are among the most frequently prescribed drugs for autism.
Although none are specifically approved for the treatment of autism, it's estimated that up to one-third of autistic children receive the drugs, often to treat the repetitive behaviors like tapping or head banging that are frequently observed in those with the condition.
A new analysis by researchers from Yale and the University of Michigan has now revealed that serious study biases have been occurring; while published research appears to show the drugs have a modest benefit in patients, in reality they have little or no benefit at all.
Benefits of Antidepressants for Autism Greatly Overstated
Drug companies have no legal obligation to publish all the results of their research; in fact, they publish only a fraction of the studies they fund -- the ones that promote their drugs. If a study does not have findings that are favorable to its product, it is highly unlikely it will ever make it into a journal for publication. In contrast, studies that have favorable findings almost always make the cut.
If you have ever studied statistics you will know very quickly that you only have to do a large number of studies to prove virtually anything you want, as if something is proved at the significance level of 1 in 100. Do 100 studies and you will find one that proves your point.
So it's not a surprise that the new analysis, published in the journal Pediatrics, found 10 randomized, controlled clinical trials of antidepressants for autism, but only five of them had been published. Of those, three showed a small benefit, while two showed none, which collectively would suggest the antidepressants may only have a modest benefit in some patients.
However, upon analyzing the data with a series of standard statistical tests that check for consistency and reliability in research data, they found a strong suggestion of publication bias – so strong that it could no longer be concluded that antidepressants are effective in children with autism. The researchers tried to get the data from the 5 unpublished studies, but only one of the authors provided results, which showed no benefit for the antidepressants.
The researchers noted:
"There was significant evidence of publication bias in all analyses. When Duval and Tweedie's trim and fill method was used to adjust for the effect of publication bias, there was no longer a significant benefit of SRI [antidepressants] for the treatment of repetitive behaviors in ASD [autism spectrum disorders]."
A separate analysis published in 2010, which reviewed seven trials of any dose of SSRI antidepressant compared with placebo, in participants with autism spectrum disorders, likewise showed no evidence of effectiveness -- but in this case they also found "emerging evidence of harm," as one child suffered a prolonged seizure after taking the drugs.i
Publication Bias is Extremely Common
There are thousands of scientific studies out there that have never been seen by you or your physician because they have been screened out by journal editors and reviewers who are being paid to uphold an industry agenda. Or, they may never have been submitted for publication in the first place.
Published studies overwhelmingly favor the funding company's drug. Remember there is NO independent third party objective arbiter doing the research. It is the drug company that pays for all of the research and they can legally toss anything that does not support their agenda. The drug that happens to be manufactured by the study sponsor is the drug that comes out on top, 90 percent of the time! And when a scientific study has findings that cast doubt on the efficacy of a drug, oftentimes the negative findings are morphed into positive ones – antidepressant trials in particular are actually notorious for this.
For example, in 2008, FDA officials analyzed a registry of 74 antidepressant trials, which included trials that were published and those that were not. The FDA's findings were then written up in an article in the New England Journal of Medicine.ii
This is what they found:
- 38 of the trials reported positive results, and 37 of the 38 were published.
- 36 trials had negative or questionable findings. Of the 36, 22 were not published at all, and 11 were published in a way that conveyed the results as though they were positive.
So, if you just went to the published literature, it would look like 94 percent of the studies were positive, when in reality only about 50 percent were positive ... giving a scientific certainty of this drug category's value in autism equivalent to a coin toss.
Massive Corruption Exists Behind Drug Approvals, Recommendations
As the Los Angeles Times reported:iii
" … the medical literature that guides how diseases and disorders are treated often provides doctors an incomplete picture of the evidence."
They are speaking in regard to antidepressants for autism, but that is but one example of many. It is often the case that a drug may appear effective and safe when you review only the published data, when in reality it is anything but. Earlier this year, for example, Dr. Tom Jefferson, of the Cochrane Collaboration, conducted a review of the antiviral influenza drug Tamiflu (oseltamivir), which was widely recommended as effective based on one published meta-analysis; but when researchers gained access to the raw data of the clinical studies, they realized the drug was being misrepresented and was not effective at all.iv
Just a few examples of the types of information uncovered about Tamiflu when researchers gained access to full clinical study reports, as opposed to published trial data, include:
- Vital details of trials (content and toxicity profile of placebos, mode of action of drug, description and timing of adverse events)
- Rationale for alternatively classifying outcomes such as pneumonia as a complication or an adverse event
- Ability to know whether key subgroup analysis (influenza-infected subjects) is valid
- Realization that serious adverse events (SAEs) occurred in trials for which SAEs were not reported in published papers
This information was enough for the researchers to completely change their opinion of the drug! In order for independent researchers to be able to confirm or refute a drug's safety and/or effectiveness, they need access to the same clinical study reports made available to regulators. The researchers continued in PLoS Medicine:v
"Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.
More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators. Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers."
If you haven't already, it's time to wake up to the harsh reality that oftentimes drugs are released to the market without being proven safe or effective – and, yes, this is true even in many drugs prescribed to our precious children.
Alternatives to Antidepressants for Autism
Autism is a complex condition with many contributing factors and it takes a multi-faceted approach to treat it. We're now also beginning to understand it requires a multi-faceted approach to prevent it, and you can read more about that here. If your child is on the autism spectrum, it's important to tackle the condition from all angles, and that includes:
- Identify and address Gut and Psychology Syndrome (GAPS) in your child. Dr. Campbell-McBride is convinced that autistic children are born with perfectly normal brains and sensory organs, but that abnormal gut flora, passed on from their mother and father, leads to devastating gut and brain toxicity. In children with Gut and Psychology Syndrome (GAPS), toxicity flowing from their gut throughout their bodies and into their brains, literally clogs the brain with toxicity, preventing it from performing its normal function and processing sensory information.
- Reduce your and your child's toxic burden: This includes avoiding as many dangerous chemicals as possible, which makes listing the do's and don'ts virtually impossible. There's just too many. As a general rule though, eating whole organic foods will go a long way, as that automatically cuts out processed foods and related chemicals, genetically engineered foods, and artificial sweeteners.
Also be careful with the personal care products you use, as well as your household cleaning products and home building materials and furnishings ... Opting for "green" and/or organic alternatives will help reduce many of the toxins most people encounter on a daily basis.
Do whatever you can to establish a toxin-free environment for your whole family, and then establish a detoxification program. Please remember hidden toxins like mold and fluoride. The book, Our Toxic World: A Wake Up Call, by Dr. Doris Rapp, is an excellent resource if you're unsure of how or where to start.
- Lower the electromagnetic field (EMF) burden in your home, especially in your bedrooms.
- Carefully review the vaccination issue, including the conventional vaccination schedule, and know that in most U.S. states you still have the right to opt out of vaccines. This is particularly important if your child has GAPS. In my view it is absolutely VITAL to perform a GAPS analysis BEFORE you consider vaccinating your child. If the test results are normal the likelihood of autism after vaccines is dramatically reduced. The child should not be given any vaccines until their microflora tests normal.
Tests to identify GAPS are available in most laboratories around the world and cost a very reasonable amount, about $80-100 per test -- peanuts compared to the incredible expense of treating an autistic child once the damage is done. The entire process for identifying children who would be at risk for developing autism from a vaccine is described in Dr. Campbell-McBride's book Gut and Psychology Syndrome.
- Avoid pasteurized milk; it's an absolute imperative to the treatment of autism. Anyone managing this illness without restricting milk is deceiving themselves. This includes all milk products, such as ice cream, yogurt and whey. Even natural flavorings in food must be avoided unless the processor can guarantee that caseinate is not included.
- Complete elimination of sugar/fructose, juice, soda, French fries and wheat (pasta, bagels, cereal, pretzels, etc) is also highly recommended.
- Get proper sun exposure. It is my personal belief that vitamin D deficiency in conjunction with damaged gut flora may be two of the most significant contributing factors to autism. Optimizing your vitamin D levels and your gut flora during pregnancy appears to be the most important prevention strategies discovered to date.