Whenever I feel like I don’t have quite enough aggravation in my life, I used to like checking out Stuart Laidlaw’s medical ethics column in the Toronto Star. For example, Stuart’s eagle eye once spotted a disturbing article about ‘marketing-based medicine’ published in the Journal of Bioethical Inquiry. It looked at the ever-so-slightly sleazy topic of data fishing. This is what Big Pharma does when science is used improperly to help market their drugs. This includes selective use of clinical trial results to suppress or spin negative results.
For the sake of clarity, let’s call this “lying”.
Another example of marketing-based medicine is the alarmingly dangerous practice of medical ghostwriting. This happens when a report that’s bought and paid for by the drug company to give a positive review of one of its products is then published in medical journals under the name of a respected academic who had little (if anything) to do with the actual journal article. See also: Partners in Slime: Why You Should Be Alarmed About Medical Ghostwriting.
In most cases, according to the JBI study called From Evidence-Based Medicine to Marketing-Based Medicine: Evidence from Internal Industry Documents, these so-called “authors” of ghostwritten medical journal articles are not even allowed to see the raw data of clinical trials. It’s a fatal flaw, the JBI researchers say, because the raw data can sometimes point to a favourable but misleading conclusion that a drug company has fraudulently selected to share with the outside world – and the academics claiming to be the authors of the studies – in order to boost drug sales.
And yet, astonishingly, some physicians still agree to lend the weighty credibility of their names to ghostwritten journal articles about research data they have not even seen.
By participating in such schemes, the study claims:
“Honorary academic authors are not just padding their CVs, they are also potentially harming public health when they fail to carefully review data presented in studies on which their names appear as authors.”
Another revealing study presented at the American College of Preventive Medicine annual meeting by Dr. Mohammed Hassan Murad of Mayo Clinic reviewed 202 published medical journal articles that addressed the now-known association between heart attack risk and the diabetes drug Avandia. Among journal article authors who concluded Avandia does NOT increase the risk, 86% had financial relationships with GlaxoSmithKline. Among authors of articles offering unfavorable reviews, only 18% had relationships with GSK. News Update: January 18, 2011: Glaxo has now taken more than $6 billion in charges to cover ongoing legal problems stemming from their drug Avandia, which has been linked to an increased risk of heart attacks in a widely debated analysis published in 2007. Since then, Glaxo has come under fire for failing to disclose clinical trial data, prompting an extensive US Senate Finance Committee investigation. See: Glaxo Takes a $3.4 Billion Charge for Avandia.
Read Stuart Laidlaw’s excellent article in the Toronto Star, or read the original study on marketing-based medicine published in the Journal of Bioethical Inquiry.
I agree that over the past decade, the pharmaceutical industry has come under increasing scrutiny with regards to poor publication practices. There continues to be a number of articles published by medical journals and the lay press regarding the issue of ‘ghostwriting’. Similarly, there has been concern that authors of medical publications on pharmaceutical products have not fully disclosed potential conflicts of interests in the articles they have written.
However, the good news is that things ARE geeting better. Partly as a consequence of the types of negative articles you mention, guidelines have been developed to help ensure that publications produced by pharmaceutical companies and independent authors meet their primary objective of providing sound and trusted educational information to healthcare professionals. Strict adherence to these guidelines should also help to re-establish the damaged reputation of pharmaceutical companies amongst healthcare professionals.
For professionals involved in publication planning, there are a number of guidelines on ethical publication practice. However, the key ones to consult are ICMJE, GPPpc and CONSORT.
There is just too much profit at stake here to believe anybody who claims that things are improving or standards are being raised or ethical guidelines are suddenly being implemented and respected. Oh please…..
Ozz, I totally respect your skepticism. However, there is more ‘than profits’ at stake here.
Firstly, there is currently a terrible relationship between pharmaceutical companies and healthcare professionals. Pharmaceutical companies have an urgent need to restore trust and the only way to do this through publications is to follow guidelines.
Furthermore, the ICMJE guidelines are compulsory to follow in order for authors to be able to publish in the more ‘prestigious’ journals (e.g. New England Journal of Medicine). These journals matter since, at the end of the day, they are the ones that will increase the stock prices of companies. These guidelines are strictly enforced by the relevant journals.
Finally, this is now a political issue. If pharmaceutical companies do not follow these guidelines then there is a very real chance of future prosecution. You need simply look at recent Senator reports (e.g. http://dianthus.co.uk/senator-grassleys-report-on-ghostwriting) to see evidence of this. Therefore, pharmaceutical companies are changing for the better in this regard. Maybe not always because they want to but because they have to.
There are rapid reforms happening across the industry (I know because I have been part of them), and the good news is that these reforms are ethical and for the benefit of clinicians and patients.
Ryan (at Woodrow):
From a PR perspective, there is an urgent need for Big Pharma to appear to be supporting ‘rapid reforms’, and it’s certainly what industry insiders want us to believe. Appropriate conflict of interest disclosure is but one part of this toxic issue. And when you already have pharmaceutical companies paying settlements of $2.3 billion, one wonders how toothless the threat of “future prosecution” actually is. It’s just the cost of doing business when you’re talking about the kind of money to be made here, as Ozz Peters points out.
Consider last year’s Senate investigation into the fully disclosed pharmaceutical financial relationships of one Dr. Alan F. Schatzberg.
The Stanford psychiatrist owns $4.8 million in stock holdings in a drug development company whose drug trials he is supervising, thus understandably raising the investigators’ concern. Yet Dr. Schatzberg told the New York Times that he had “fully complied with Stanford’s rigorous disclosure policies and federal guidelines that pertained to his research.”
How could this kind of insulting denial possibly “benefit clinicians and patients” when even the physicians themselves don’t seem to get it?