How are you familiar with this unpublished study? If results are readily available on the FDA website, then I think it would make a nice commentary. I just wrote a somewhat similar paper on a weight loss drug after a detailed review of publicly available FDA panel minutes. However, if these are not publicly available data, I would advise to steer away from the paper due to potential litigation arising from divulging proprietary information.

Thanks Kevin, I intend to publish a commentary in AJHP. But, how else can I increase awareness?

Thanks Larry, the information that I discussed is on FDA website (attached). I would be interested in your commentary.

John, without reviewing this document in detail, it does appear that the primary endpoint was met in both placebo-controlled trials (although the treatment effect in one of them seemed quite modest. In the head to head trial with bupivacaine, the AUC pain scores were actually higher with Exparel. It appears that there are numerous confounding factors involved in this analysis including different indications, different post-op follow-up periods, different dosages, different comparison groups, etc. It also appears that the FDA doc minimizes the results of the head to head trial with bupivacaine and focuses on the placebo-controlled trials. My manuscript could likely serve as a rough template for yours. That is, introduce the drug, the mechanism of action, describe the trials and their results, then discuss the nuances, including its comparative performance vs. the exponentially cheaper, yet similarly effective, bupivacaine. Larry

Thanks, interesting about the DSM.

The book "Bad Pharma" by Ben Goldacre offers some interesting insights into the whole industry and devotes a specific chapter to Marketing and possible solutions/actions that can be taken - I thoroughly recommend it. Carl Elliott's: "White Coat, Black Hat: Adventures on the Darker Side of Medicine" is also and excellent read and has some interesting information about this aspect of the pharmaceutical industry (but doesn't specifically make recommendations for action).

Thanks for the suggestions on references. I am also reading a book called 20 ads that shook the world. Some are medicine related, most are not. Very interesting reading. http://www.amazon.com/Twenty-That-Shook-World-Groundbreaking/dp/0609807234

There are times in which an expensive version of a drug is effective for an individual while the less expensive one is not. I would urge caution in drawing any conclusions based on one study that is only available from the FDA. That is not to say you should not publish, only use caution.

Thanks Martin and do agree that drugs do not universally work for every individual, independent of expense.

Actually, much of my quandary is that this trial is only available from the fda and is not fully published (and may never be).

Part of my original issue was the non-publication of pivotal data. Since then, have found a couple nice references that address this area.

And this as well

I have to agree with the point of this post. The drug companies love to make a killing while they have the patent and if they can make some trivial change and get a new patent, advertise their "superiority" and get it away with it they will. Witness the Colcrys/colchicine debacle - even the NEJM called them out on it, and they are still raking it in and even nervy enough to advertise as if it is a wonderful new drug.

It's quite hard to stop dubious marketing as there are always ways to get round legal or regulatory loopholes. Perhaps the problem can be approached from another angle, stopping it's effects rather than stopping it's existence.

Here I'm thinking of better information or education of the medical profession. In turn, the profession has to educate their patients who intuitively think that newer is better.

I totally agree with your position on the transparency that should be around publication of clinical trials results.

Publication of clinical trial results varies among pharmaceutical companies.

Have you tried to contact anyone from the manufacturer company in order to request the trial results? Or to engage in any discussion around this specific topic? It would be interesting to know what is their position on this matter.

I do not know the marketing laws and standards in context. I’m sharing my thoughts based on my understanding of data provided. I did not find error in terms of therapeutic effect and side effects in Exparel versus bupivacaine. In my understanding of your data the two medications yield similar therapeutic effect and the only difference is the price value in the market Exparel cost $300 and bupivacaine cost $2. Personally I did not find ethical issue or dilemma since there is no harmful effect in human. It’s drug pricing issue. The agency/state regulation on trade and industry needs to address the price cost.

Your transparency and knowledge contribution are fully appreciated but there is a need to consider related and relevant laws in context because it involves not only the ethical component but also legal component

I strongly agree with Martin Lenhardt . It is good to consider his suggestion.

I had similar thinking like yours. Daflon 500 mg venotropic drug for venous insufficiency and venous tone up. Two drug companies market Daflon 500mg with 50% price cost difference. Generic product costs less than branded product. The thinking of some consumer is low drug quality at low cost and high drug quality at high cost. This thinking drives consumers to go for branded drugs. It is the responsibility of the state to regulate and monitor food and drug to protect the consumer's health. Drug products are required for assay test before it is out in the market to protect the consumer’s health.