More Big Problems With Big Pharma: Clinical Trial Information Publication

Pills (white rabbit)
Pills (white rabbit) (Photo credit: erix!)

Did you know that approximately half of all clinical trials conducted and completed are never published in academic journals and trials with positive results are twice as likely to be published as others?

And:

In 2007, a law was passed, saying all trials in the U.S. on currently available treatments must post their results to clinicaltrials.gov within a year of completion. Everyone rejoiced… claiming the problem was fixed. But nobody audited to see if the rules were followed, and in 2012 it was found that four out of five trials had ignored the law. Despite very poor compliance, no fine has ever been levied for failure to comply with this law.

[Underline is mine.]

If you’re a regular reader of my blog, you’ve already heard me talk on this topic.  I’m posting about this subject again because this past week, Dr. Ben Goldacre once again surfaced to promote his new book and remind the public that doctors really are prescribing blind.

If you’re still skeptical, consider this:

A doctor today who qualified in the 1970s is basically self taught with respect to almost all the medicines they prescribe. Medicine has changed entirely around them, through their career. We need to be better at future proofing medics, and teaching them how to find reliable sources of information. When you ask doctors “how do you know” which treatment is best, the answers are worryingly variable. “It’s what the doctor in the office next door told me” “I saw a drug rep” “I read one trial” etc. We need to develop better systems for disseminating evidence, as we currently rely on legacy systems such as journals and conferences, and also, worryingly, approaches not entirely dissimilar to oral traditions.   This means we carry on using things that aren’t so great, but also we’re slow to take up new treatments. Remember, the first social network theory paper, on diffusion of innovation, was done in the medical profession. It’s a real problem.

I’ve said it before and will say it again.  The, “I had a visit from a drug rep,” is something that especially concerns me.  When the physical evidence in the doctor’s office points to a recent visit from a rep hawking the drug-of-the-moment, i.e. an Abilify clock in the waiting room, yellow and blue umbrella by the door and a Bristol-Myers Squibb pen in hand as they write the prescription – it’s pretty certain I already know which drug I’m leaving with a ‘script for.  But, let’s not be so pessimistic for a moment.  “…marketing…can easily be ignored by any good doctor. When the evidence on what works is systematically distorted, when trial results are withheld, then nobody—not even the best doctor in the world—can truly know which treatment is best.”

Very true.  And to be fair, not all doctors are mesmerized by drug company swag. Dr Richard Lehman:

It is a scandal that doctors like myself often prescribe treatments without knowing their true benefits and harms, because research evidence from human trials has been withheld. That means that over my 35 years as a GP, I have unintentionally spent large sums of NHS [UK healthcare system] money on treatments that did not work, and some patients have suffered avoidable harm. We need immediate access to all the data relating to all the drugs and devices which we use on millions of people every day.

What your prescribing doctor needs is all of the applicable information.

Dr. Goodacre and several physician colleagues have founded a petition/initiative called AllTrials , aimed at mandating all drug trials past and present be registered, and the full methods and the results reported.  It calls on governments, regulators and research bodies to implement measures to achieve this goal.  If you’re intrigued, the Missing trials briefing note that is found on the AllTrials website is a good place to start.

The petition, although at the time I wrote this post had only 39,824 signatures, has an impressive list of organizational supporters.  This didn’t seem like much momentum to me, but then I stumbled across the commitment GSK made to supply the results of all their clinical trials. GlaxoSmithKline, let’s not forget, in late June 2012, was ordered to pay $3 billion in a fraud settlement for shenanigans such as, “…employing tactics aimed at promoting the use of the drug [Paxil] in children, including helping to publish a medical journal article that misreported data from a clinical trial.”  So, GSK signing on to participate in AllTrials should rebuild their image and make supporters of AllTrials happy, right?

Hold the Applause.  GSK doesn’t deserve any kudos just yet.  (After losing the last game to the tune of $3 billion, did you really think they were going to play fair in the first inning of AllTrials?)  But, they are playing.  They’re still in the game.  And that says something.

Yes, maybe this post is another self-indulgent rant, but things need to be change.  As an individual who has to take medication for the rest of their life to control their condition, it’s frightening to see how I am literally held hostage by Big Pharma’s antics.

Updated and Related:

A few hours after I hit Publish, I came upon this article from TimeHow Our Web Searches Could Expose Drug Side Effects.  Self-report side effects sites have been around for a while, but a group of researchers at Stanford University School of Medicine and Microsoft Research are taking a different tact.  Why not look at the actual search habits of patients to determine what side effects, potential drug interactions, etc they are keying in on?  If doctors and patients aren’t getting all of the clinical trial information, doesn’t it then make sense to ask the actual guinea pigs what’s going on?  

 

 

References

Live Chat with Ben Goldacre: How Bad is the Pharma Industry – The Daily Beast, March 5, 2013, 11:00AM EST

AllTrials – An initiative/petition aimed at mandating all trials past and present  be registered, and the full methods and the results reported.  It calls on governments, regulators and research bodies to implement measures to achieve this goal.

Truth About Your Medicine: Ben Goldacre on How to Reform the Pharmaceutical Industry – The Daily Beast, March 4, 2013

Another Psychiatric Med Debacle: Glaxo Agrees to Pay $3 Billion in Fraud Settlement – Manic Muses, July 4, 2012

Promises of Transparency?  Hold the Applause – British Medical Journal, March 6, 2013

How Our Web Searches Could Expose Drug Side Effects – Time Magazine, March 7, 2013

This just makes me shudder. A friend started going to a new doc yesterday. My friend has diabetes, which she controls with diet and exercise–no insulin, no meds. The doc wanted her to start taking a new injectable drug just because one of the side effects is *possible* weight loss (my friend is overweight). Really?

*Possible* weight loss? Seriously? If she’s controlling her diabetes with diet and exercise… Did doc have a clock and pen in his office from the manufacturer of the injectable?? 🙂

Interesting post. An inherent problem with clinical studies is that they are not conducted long enough to determine an “exhaustive” list of side effects in general, let alone long-term side effects. Pharma companies generally do not do their due diligence, mainly because they are a business and it is not in their financial interest to invest time or money. A potential issue with allowing self-reports of drug side effects, from my perspective, is the possibility for people to be hypochondriacs. And one hypochondriac can spoil the bunch. If you look at clinical studies for anti-depressants you see that the placebos are as effective in ameliorating depressive symptoms as are the anti-depressants themselves, simply because people believe the the pill is working. So, there is the potential for a symptom snowball effect where more people believe they have particular symptoms than they actually have. Thus, you would see a surge in online searches for side effects that may not be prevalent. With sufficient oversight, however, Stanford and Microsoft Research may be on to something…

Hi, Nicole – thanks for commenting. I’m just a nerd who likes to read package inserts, but it always struck me as odd that many antidepressants are just about as effective as the placebos. Anyway, yes, Stanford and MS might be on to something, but who or what body is the right one to provide oversight? I’m not sure. The FDA is the obvious choice, but probably wouldn’t/couldn’t get involved ($). Pity.

4 Comments

Leave a Reply

Abilify
3
Abilify in Court – July 2017 Update

It’s been five years since I wrote, Success! I’ve Quit Abilify.  Since then, the post has received over 3500 views.  And all told, views for posts (linked below) related to the BS I endured while taking Abilify total over 49,000. The struggle is real. I haven’t posted for over a …

Bipolar
8
Polypharmacy and Bipolar Disorder

How many meds do you use to treat your bipolar disorder?  And your co-morbid afflictions?  Personally, I get off easy and take only four. In the treatment of bipolar disorder, polypharmacy (the use of multiple meds to treat a disease or disorder) is the norm.  And generally, bipolar I patients …

Bipolar
5
Heritable bipolar phenotypes pinned down

(I don’t usually quote an entire article, but this subject is near and dear to my heart….) Heritable bipolar phenotypes p inned down Published on February 14, 2014 at 5:12 PM By Eleanor McDermid, Senior medwireNews Reporter   A large study has pinpointed brain and behavioural traits that are genetically influenced and …

error: Content is protected !!