Cymbalta v. Lexapro Head-to-Head Study
This may speak more to my ignorance of intracies of antidepressant clinical study design - but why did Eli Lilly choose a head to head (H2H) study with Lexapro - an SSRI class antidepressant - instead of another SNRI like Effexor? Google News / Google Search
Whatever the reasons may be, there were no significant differences in efficacy between the two drugs although there are some safety differences (more dry mouth and nausea on the Cymbalta arm than sugar pill or Lexapro arm). The study was a double-blind radomized placebo controlled trial, which gives a high level of clinical confidence (i.e. how much you can trust the results of the study as true results and not because of other factors including biases or spurious effects). At the very least it means patients with depression have another drug that works so that if one cannot tolerate the side effects of a drug, there are others to choose from.
Ethics is Behavior not a Statement
In line with my previous post, I became aware of a call for ethical standards for bloggers of healthcare information. Now, I’m not sure I consider myself a “healthcare blogger” although I’ve been using blogging software to support this website for the past two years. The closest I came to blogging on this website was chronicling my experiences with medications back in 1998 - and by no means was I trying to inform or make any statements. My purpose was sharing my experiences - the good, bad, and ugly sides of depression.
This site has been adhering to the HONcode, which includes many of the ethical standards called for in sharing healthcare information. Of course if I had to stick to how often the site is updated my site wouldn’t make the cut, since I update the site sporadically. However, the most important elements include disclosure - who pays for what and how much and when. Disclosing present and past associations and potential conflicts of interest are key - I’ve been employed in the pharma industry in the past, and I disclose what therapeutic areas I used to work in. What ultimately matters is not what I say on the website but how I conduct myself consistently over the years. I think patients and consumers and most web visitors can spot a phony a mile away no matter what the phony claims in any “standards” page.
Some may say that HONcode is a start and we can always have more developed and clearer guidelines. I can’t argue with clarity. I just think right now, we need consistency and transparency more urgently than additional clarity. Half the time we can’t really prove what we claim without making public our financial statements or records that have traditionally been demanded of publicly traded companies. Ultimately the patients are still dependent on our verbal and blogging claims at face value.
Interestingly, around the same time I learned of this topic was when I had been mulling over an idea that I wanted to implement for almost 3 years. Like all of my ventures, this idea came from an unmet need that still isn’t being well-met. This need is the shroud of mystery that continues to surround medical and drug information. It goes along with my previous post about the transparency of information.
If you as a patient goes on a clinical trial website and click on the clinical trial links that drug companies now have to offer to the public, would you actually know what you’re looking for? Do you know what inclusion/exclusion criteria means to you, and why you can’t be included in the study for what reasons?
Even more basic, let’s take a package insert (what docs commonly refer to as “PI”) of a drug you’re taking. It’s a piece of paper with text printed the size of baby ants. There is small text on both sides, some are bolded, some aren’t. You may even notice a black box that looks a bit menacing. Do you, the patient, even know what you’re looking for on this piece of paper if you get a hold of it? This piece of paper represents all the clinical studies that drug companies had done to prove that their drugs are safe and that their drugs work for the condition the drug is approved for. Sometimes docs will even look at the PI to make sure that the drug isn’t interacting with some other drugs you’re taking if you are prescribed the drug.
With the internet and globalization of information, we have no shortage of information. But what we still lack is basic understanding of what all this information means for our patients.
Can You Trust the Information?
I’ve noticed that as our access to information increases, our confusion to the information and our suspicion of the agenda behind available information also increases.
Can we trust the information we get from our many options? Even before trust - do most people actually understand the information with all the scientific jargon and technical speak?
One of the reasons I founded this website was in response to a father who was reading a scientific journal on a study that has some implications on bipolar disorder, and he didn’t understand what the study was talking about. The science was extremely abstract and practically inaccessible to consumers.
Recently pharma companies have made their clinical trial information accessible to the public. “Transparency” is the buzz. I don’t believe this increases “transparency” to patients. Maybe to physicians and scientists and of course, competing pharma companies. But I’ve seen these clinical trial portals and I can’t believe that most patients and consumers know what the information means or whether they should care.
What do you think?