Friday, September 11, 2009

Sometimes You're Paranoid, but Sometimes They Really Are Out To Get You


With the endless news cycle surrounding health care reform lately, it’s easy to have missed some other breaking and troubling news. In the past two weeks, we have Pfizer paying $2.3 Billion in reparations for faulty marketing; we have a smoking gun with CME being used as blatant drug advertising by Forest labs (the makers of “Lexapro”, the wonder drug)- you can actually read the words themselves in a lovely pdf, I love Part IV. Promotional Objectives:


Maintain SRI category leadership in total number of medical education events
(including CME symposia, speaker programs, teleconferences, and peer selling
programs)

and now we have the invisible hand that pulls all the triggers: Ghost writing in Medical Journals . Unfortunately this last piece of research has not been peer-reviewed or published yet, but prior work by the same authors has shown worrisome rates of ghost authorship previously.

When I think about the drugs I use for my patients, the journals and lectures I rely on for my ongoing education, I am becoming more and more troubled. If the drug companies fund the studies, write the papers, market the drugs, provide my education surrounding them, and fund the guidelines I use to guide my decisions, how can I avoid giving my patients drugs that do them harm?

This is why we have government, when markets fail to self-regulate, when they are too opaque for any one human to suss out the truth, this is where the government should step in. And yet, even here we see failure. I remember learning about the Clinical Trials registry in an ethics class, as a way that drug companies could be kept honest. They register their studies, their outcomes, their plan, and we can see if they keep their word. And it sounds like a great idea. At least this way, someone would know who’s doing what research out there, but what do we find? Drug companies don’t use it. Why should they? A new study last week in JAMA revealed that drug companies don’t register their studies half the time; that even when they do, they report only selective outcomes, not necessarily the ones they indicated in the database. We all know the equation: sponsorship + research = positive outcome, but why can’t the Journals, the physicians, the public, someone, anyone, do something about it?

I like clinical research, I find it rewarding to have a clinical question and find an answer for it, with the hope that it may help some other physician or patient out there. With the comparative dearth of clinical research in older adults and palliative care being such a new relatively new field, I worry that the drug company influence in our lives may be even greater because there is less alternate competition. I don’t want to hurt my patients and when someone wants to hammer down my patient’s HgbA1c below 7, I cringe. Isn’t chasing the HgbA1C just another drug company ploy for my 80 year old patient? But how can anyone keep a clear head when we’re flooded with information that these are good things to do, that I'm a bad doc if I don't. I honestly have no solutions to this problem, only a nagging concern that fills me with worry and dread and keeps me up at night. Maybe I need some Lexapro?

-Chrissy Kistler

*This blog-post was sponsored and ghost-written and edited for content and posted by Geripal.

5 comments:

Jan Henderson said...

There’s also an interesting article on ghostwriting in the most recent PLoS Medicine at:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000156

“If you are an editor, author, reviewer, or reader of medical journals, or if you depend on your doctor or health care provider getting unbiased information from medical journals, then the 1,500 documents now hosted on the PLoS Medicine Web site [1] should make you very concerned and angry. Because, quite simply, the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.”

I’m sure everyone here will be interested in this article from The Lancet: “The Death of Ivan Ilyich and pain relief at the end of life.”
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961616-0/fulltext
(subscription not required, but you do need to register for the site to read the whole article)

They take a very interesting position that I don’t often see.

“Pain relief should never be withheld when it is desirable. Nor do we think that physical or existential suffering is, necessarily, redemptive or edifying in any way. But, it might be for some people; there might be someone for whom, as for Ivan Ilyich, the suffering of dying is a path to self-understanding or spiritual awakening. Should this be something that matters to the physician?”

I wonder whether the American public is ready for this. How different is dying in the UK?

The Lancet article links to this blog, which is how I found you. What a wonderful blog! Thank you!

Alex Smith said...

Thanks Jan for the shout out about our recent Lancet publication. See our new post about written by Eric Widera.

Chrissy, these are serious issues. Big pharma has a role to play, and I do believe that some degree of private research and competition is important and beneficial. The question is similar to the questions being raised about the financial markets: how much regulation is optimal?

I believe we need two fundamental changes to the way pharma is currently regulated: First, the incentives for profit need to be aligned to a greater extent with the best interests of patients. For example, greater incentives for vaccine development. Pharma currently has little interest in vaccine development simply because they have little potential for profit, especially compared to medications patients might use daily for life.

Second, we need better safeguards in place to regulate pharma. Pfizer was fined $2.3 billion - sounds like a lot - until one considers that represents a mere 3 weeks of profit for the drug company. And this whole Bextra mess happened after Pfizer signed a statement promising to be good after the Neurontin scandal. Finally, these law suits are retroactive action, not pro-active. What is obvious from these issues is the need for tighter regulation at the level of trial registries, journal publication, and direct detailing to physicians.

Finding the optimal balance of regulation is tricky -- too much and the "red tape" will hinder competition and innovation. Clearly, we're at "too little." The bottom line that's affected with two little regulation? Patients' pocketbooks, health, and even lives.

Dan Matlock said...

Thanks for this post.

One of the best lessons of geriatric training - apply guidelines with caution. It is even worse when someone pushes the A1c to < 7 while ignoring something much more important such as hearing, vision, or incontinence.

Mike Steinman said...

The real challenge that arises from drug industry marketing has been its erosion of the firewall between commercial and scientific content. In particular, industry is involved in almost every facet of a doctor's professional life - from the sales representatives that we see in our offices, to industry sponsorship of the journal articles and CME programs that we use to keep current, to influence over local and national thought leaders who we turn to as models and teachers of best practices.

Gary said...

Alex & Eric, Thanks for the blog!

I see something else that is quite insidious in our teaching hospitals as well - "the formulary". Pharma reps are increasingly banned from housestaff lunch conferences and clinics to prevent them from influencing young impressionable minds - this is not a bad thing in my opinion. However the hospital then negotiate for preferred medications, often with cost being a big component of the decision making process. Residents then are programmed to prefer and use certain meds that they become familiar with over time, because it's there...