Journal Publications Are Nothing But Marketing
12 CommentsBy Ed Silverman // February 26th, 2008 // 9:57 am
But you probably knew that already. In any event, many big drugmakers view the publication of clinical trials primarily as a marketing tool, not just a way to get the word out to docs about meaningful findings. That’s the result of a recent survey by Best Practices, which queried scientific directors at 14 big drugmakers - Glaxo, Pfizer, Biogen, Human Genome Sciences, Merck, Bristol-Myers Squibb, NPS, Abbott Labs, Shire, Amgne, Genentech, Lilly, AstraZeneca and Vertex Pharmaceuticals.
According to its report, the firm found that six drugmakers include the ‘publication function’ in marketing, while another six placed it in the medical or clinical group. Of the remaining two drugmakers, one is moving publications toward the medical team, but the other believes its in the proper place -at the “juncture of commercial and clinical.”
In discussing the findings, the research firm notes that “scientific publications are an essential tool for both clinical and commercial purposes, as they are intended to influence the target audience by raising both awareness of the disease and awareness of a company’s product.” And so where do you think the publications teams will find themselves once the FDA’s new rules for distributing journal reprints become finalized?
Hat tip to Integrity in Science Watch
WBP
Whether the publication function is in marketing, medical, or medical marketing, it is still controlled by commercial interests. The commercial teams will push for ungent publication of positive results and seek to bury negative results. It’s been going on for at laest the past 20 years. Even when the pressure is put on, they just shift the location of the department rather than the control. The same is true for many other “medical” functions, like medical information, educational grants and continuing medical education. Commercial is supposed to be hands off, but they’re not. Any statement otherwise is simply not true! The companies are business first, science later.
CA MD
These findings are exactly why the FDA’s suggested guidelines to allow reps to distribute reprints is a very. very bad idea. First of all, the companies are selective about whatever appears in print and where. Then the rep will be selective about what he/she hands out. The docs will only see the most positive, most convincing, most marketable data that the companies have and never receive a balanced picture.
Nathan
WBP says:
“The companies are business first, science later.”
Duh. Is this suprising to you? We are in the buisness of doing science — but we ultimately report to our shareholders. If we aren’t making money, then we are toast! If you want science to be done in a more altruistic manner, I suggest you join the NIH…
When was the last time the NIH commecialized a lifesaving drug? Mmmm… I think it’s been quite a while…
Doc
CA MD above is exactly correct. Pharma companies know reprints are their best marketing tools, study design is a fine art to try and assure good outcomes for the study drug. To relax reprint/offlabel rules and allow the hoards of unqualified sales reps to use these resources is a bad idea.
WBP
Hey Nathan,
Science should always been done with integrity. Reporting the results of science should always be done with honesty. The problem physicians have with how data is shared with them is that it’s unfairly biased to the positive for the pharmaceutical company. Allow the physician to make his/her decision based on all the facts. I’ve been in pharma and I know. The companies seek to bury the negative studies as deep as they can and hope they never come to the surface. It’s dishonesty by ommision!
Similar problems exist with DTC campaigns. The pharmaceutical companies spend huge amounts of moeny on this in the US in order to drive the patients to the doctors asking for a particular drug product. This puts physicians in a very bad position. They like to keep their patients satisfied, but many times the advertised drug is not the best drug for the patient. Yet, the pharma company has put it in the patient’s head. If they want to do DTC, then do patient education about medical issues - like they do everyplace else in the world!
WBP
BDM
Sad to say it, but CA MD is right. Many of the Big Pharma companies go to great lengths to completely bury or dramatically delay the release of negative study results. Just consider the recent fiasco with Schering-Plough and Merck regarding the ENHANCE study. The trial was completed in April 2006 and we just heard the top-line reults last month. It’s to be presented at the ACC, but how much will we really learn. And when and where will it be published? 2010 in a throw-away that barely qualifies as a journal. And will MSP reps ever hand it out? No way. If the study has positive results, they’d already have it in their detail aid!
John Mack
This being the case, should the FDA be making it easier for drug companies to distribute journal reprints on off-label uses of drugs to doctors?
I invite comments on this from Pharmalot readers: http://www.surveymonkey.com/s.aspx?sm=qEIF5viL3uuk95HefNunDg_3d_3d
Someone
It is actually much worse than just the fact that published journal pieces are in the domain of marketing. Working in Pharma marketing for many years, the budget for this comes out of marketing, not clinical. Additionally, lets keep in mind the fact that most if not all of these studies are “ghost” written or written by the drug companies themselves. In most cases the primary investigators of the studies do not even get to see the raw data of the trial they are the primary investigator on. This makes it difficult if not impossible to determine what the actual results of the trial were.
This is becoming such a problem that finally some medical associations are issuing a directive to their physicians that un less they are provided with all the raw data and actually have written the report themselves then they should withdraw their name from the study or prepare to face the consequences.
In light of the fiasco with anti-depressants I wonder if anyone would take on the task of back-tracking and pulling all the studies on those drugs and launching investigations into the authors of those studies. Afterall it was those studies that allowed so many patients to be duped for so long, not to mention the financial impact to the patients and governments alike. There are also some other health issues and long term consequences facing patients who were on these drugs.
Physicians must be made to comply with full disclosure. It is apparent that Pharma can “buy” their way out of trouble. If we can’t nail the crooks, lets make it difficult for anyone to play the role of accomplice!
Lead us not into duplicity! - oops seems we’ve been happily esconced there all along…
Dan
The way pharma companies create these marketing tools as clinical trials is rather distrubing. First, they have those with minimal experience in research to conduct these studies for enormous amounts of money per subject. The IRB is typically for profit and in collusion with both the CRO and the sponsor of the study. Ghostwriters tailor these studies afterwards with clear embellishments and inaccuracies, yet they still get published in journals. Journals publish them because the pharma companies pay the journals huge amounts of money to do so with the agreement that the pharma company will purchase large amounts of reprints of these marketing tools.
It’s an insult to science and scientists past and present.
Justice in Michigan
Some excellent, thoughtful comments in this thread.
Question: As far as I know, FDA has no control whatsoever over medical journal editorial policies, and thus contents.
(Of course, I’m not talking about distribution via reps, etc.) Thus, former FDA officials have commented on seeing published studies in which endpoints were changed or otherwise cherry-picked, while having the full data set themselves. Still, as FDA, they were not in a position to make public comment.
Is that in tune with others’ understanding?
Bob Freeman
Justice, yes, that is my understanding also.
Chris
Great comments on this thread, I wish this topic could be held and tracked more closely by Ed Silverman or others. This topic together with the financial relationships between physicians and phrma really gets to the heart of what’s wrong with phrma today.
Sadly, while there are some great comments here, I think that there are too many folks in phrma management who think like Nathan. Yes, phrma is for-profit. And I think that’s important and good. Reward drives innovation and that has been a hallmark of american industry, particularly in the pharmaceutical and it sectors. The problem is that we cannot let return to shareholders justify all conduct. If you take that argument too far, you can justify Enron, you can justify Merck and Schering and you can justify Mattell having kid’s toys painted with lead in China. Yes, absolutely, phrma is high-risk high-reward. But the end does not ALWAYS justify the means. More importantly, as an industry phrma needs to think about its success and viability in the long-term. Sometimes that could mean decisions that might come at the expense of short-term revenue.
And that is where phrma has failed. The need to sell growth targets to the street and meet them year on year has forced bad decisions that have hurt us in the long-run. And I don’t see anyone at my company or in the industry with the courage to step up.
I have worked at three companies with many brands. I have seen the scientific process corrupted by marketing people who do indeed see scientific publication as a marketing tool. Medical budgets have been moved from the research side to the marketing side. Medical and publication plans are driven entirely by the marketing plan. Content is ghost written. Authors have deep substantial financial ties with companies that are not disclosed. And there are moments when you see it all come together into something totally indefensible. I have seen manuscripts with suggested edits by marketing people toning down the safety language. Are we really prepared to say that that’s acceptable because of our overriding duty to maximize shareholder return? Where is the limits on the argument?
I am so disappointed because I have come to the firm conclusion that change will not come from within the industry. You get the sense that we are on a slowly sinking ship with all the power players trying to grab as much as possible before it goes down. Then the rest of us will be left in a salvage operation.
And it’s not just the phrma execs. The scientists and doctors who take advantage of the situation are just as responsible. There are physicians who put their names on articles that phrma companies drafted and they will draft or agree to disclosure statements indicating no or minimal relationships when in fact they serve as speakers, they serve as consultants and they have received substantial grant monies for CME and “independent studies.” Many of these physicians could literally be making 100’s of thousands of dollars in fees per year for all sorts of different programs for a particular marketing team, yet they will allow a disclosure that says “Dr. So-and-so has served as a consultant for ____” (if you even get that much disclosure). It’s not enough. Spell it all out and let the readers gadge credibility with complete transparency.
The problem with too much influence in scientific publication is that people don’t understand the influence and therefore are prepared to give more weight to some of this material than it deserves. People understand the inherent bias in DTC ads and marketing material. But they tend to expect credibility and integrity in scientific journal articles. However, the influence behind the scenes is substantial, even shocking. And as some of the commentors have noted, it’s a practice that is not actively regulated by the FDA.
But the seeds of change are there.
- Journals are adopting tougher standards for authorship and disclosure.
- The pressure for transparency (while still weak) is growing.
- Pharma blogs allow stories like this that would never get picked up mainstream.
Medical journals need to show leadership where phrma and its favorite physicians have failed to do so.