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more on the phenomenon known as “underreporting” as related to invisible and abandoned studies


Underreporting Side Effects

Serious concerns have emerged regarding publication bias or selective omission of outcomes data, whereby negative results are less likely to be published than positive results. This has important implications for evaluations of adverse events because conclusions based on only published studies may not present a true picture of the number and range of the events. The additional issue of poor reporting of harms in journal articles has also been repeatedly highlighted. In addition, reporting discrepancies, including omission of information, have recently been identified between studies published as journal articles and the corresponding unpublished data.  From the study we are looking at today

All through college I was a straight A student.  That is, as long as you threw out all the classes I got B’s and C’s in.  It’s not that different from my record-shattering ability to shoot free throws (HERE). Welcome to my world, where I can declare my perfection since my failures never count. 

As absurd as the paragraph directly above is, that is exactly the sort of mantra that BIG PHARMA is living by.  If they don’t like the results they’re getting in a certain study concerning a certain drug?  Simply stop the study, bury the results so that they never see the light of day, then redo the study in a slightly different manner.  By using “science,” it’s really not difficult to make your product look better than it is, as there are dozens of techniques for accomplishing this (HERE).  This phenomenon of the pharmaceutical industry abandoning research they don’t like is so common that it actually has a name — “INVISIBLE & ABANDONED“.   Case in point, the brand new study from the medical journal PLoS One.

Earlier this week, they carried a meta-analysis of numerous studies on this topic called Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review.  We already know that UNDER-REPORTING ADVERSE EVENTS is a problem of epic proportions in the scientific biomedical community.  “Despite the difficulties in obtaining and incorporating unpublished data into systematic reviews,” the authors of this study used a number of methods, including various ‘Sunshine Laws’, to gain access to the invisible and abandoned studies on certain drugs.  They then compared, “the number of adverse events, the types of adverse events, and the risk ratios of adverse events,” from these unpublished studies to the same from the studies that actually made it into print.   What did the authors determine (cherry-picked)?

“The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents.  Incomplete reporting of adverse events within published studies was a consistent finding across all the methodological evaluations that we reviewed.  Our findings suggest that it will not be possible to develop a complete understanding of the harms of an intervention unless urgent steps are taken to facilitate access to unpublished data.  Our findings suggest that poor reporting of harms data, selective outcome reporting, and publication bias are very serious threats to the validity of systematic reviews and meta-analyses of harms.  In conclusion, there is strong evidence that substantially more information on adverse events is available from unpublished than from published data sources and that higher numbers of adverse events are reported in the unpublished than the published version of the same studies.”

By gently (or vigorously as the case may be) massaging the studies to get the results you want, and then throwing out anything you don’t like, you can make even the crappiest of drugs look fantastic.  We’ve seen this happen with DIABETIC MEDICATIONS and we’ve seen it happen big time in ANTIDEPRESSANTS (many researchers claim that if science included the abandoned studies on antidepressants, this class of drug would not exist).  And most recently we’ve seen it with the drug Alli (a WEIGHT LOSS PILL).

Alli has been around for at least two decades, and has been prescribed under many names (it’s common name is Orlistat).  It also happens to be renowned for its nasty side effects such as explosive diarrhea and incontinence.   And that’s for starters.  Throw in fun things like liver failure and you can see how much the ante has been upped.  Freedom of Information Act requests allowed interested parties (namely the authors of the PLoS One study above) to get their hands on Orlistat research from the 1990’s.  Not surprisingly, they found that authors were publishing as few as 14% (up to a high of one third) of the adverse events associated with this drug.  The rest?  Buried.

How did the drug work?  It billed itself as preventing your body from absorbing dietary fat.  The problem is, science has known for decades that it’s not fat that makes you fat, but sugar and processed carbohydrates (HERE & HERE).  The other problem is that when you don’t absorb dietary fat, you excrete it in your stool.  I’ll let you imagine the sort of foul, oily, mess this could bring about at the most inopportune of moments.  Thus it was not a surprise when the April, 2007 issue of the International Journal of Obesity (Long-Term Persistence with Orlistat and Sibutramine in a Population-Based Cohort) concluded that, “only 2% of patients persisted with orlistat or sibturamine therapy at 2 years.”  But then again, only 6% could stick with it for even 12 months.

What did the drug manufacturer’s spokespersons have to say about this fiasco.  Roche’s Anja von Treskow merely stated that everything, “was done according to the standards of the time.”  GSK’S Joanmarie Goddard said that they, “take adverse event reporting for our products very seriously and routinely monitor safety information in conjunction with health care professionals and regulatory agencies worldwide.”  How fun.  Spoken like experienced politicians who are experts at damage control, avoiding answers to tough questions, and using flowery language and big words to never say anything of substance.  Don’t address the issues, just smile and tell the public how good we’ve done in the past and how we are striving to do better in the future.

More proof that your goal should be getting off as many DRUGS as you can.  Why?  It’s a no-brainer.  They are more dangerous than we were ever led to believe.  As you can see from studies like this one, far more dangerous.  EVIDENCE-BASED MEDICINE has proved exactly one thing — that the emperor really is naked after all.  My suggestion to you would be to learn everything you can about inflammation (HERE), and then create a plan to squelch it (HERE).  It’s your lucky day because I’ve done most of it for you already.  All you need to do is the “heavy lifting” required to get started.  If you can get two weeks under your belt, you’re off to the races.  It really does get easier the longer you stick with it — even if you are ADDICTED TO SUGAR AND JUNK CARBS.


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