a shameful misuse…

Posted on Monday 8 July 2013

by Dennis K Flaherty, PhD
Annals of Pharmacotherapy. 2013 47:1081-1083.

Industry-sponsored ghost- and guest-authored clinical research publications are a continuing problem in medical journals. These communications are written by unacknowledged medical communication companies and submitted to peer-reviewed journals by academicians who may not have participated in the writing process. These publications, which are used for marketing purposes, usually underestimate the adverse effects and medical risks associated with the products evaluated. Since peer-reviewed data are used to develop health care paradigms, misleading information can have catastrophic effects. A failure to curb ghost and guest authorship will result in an erosion of trust in the peer-review system, academic research, and health care paradigms.
hat tip to Pharmagossip   
Jack Friday points us to an article that tells us something we all know, but gives an interesting review on the state of play in the full-text paper available on-line.
A significant number of papers appearing in peer-reviewed biomedical journals are ghost authored. In 2008, a review of 632 articles published in 6 medical journals with high impact factors showed that 21% had evidence of ghost authorship…

The number of industry-sponsored ghost- and guest-authored publications in medical journals is difficult to determine. These publications become visible only during litigation and industry attorneys usually request the courts to seal all documents to prevent additional liability claims. However, some courts have unsealed internal documents showing ghost and guest publications related to 3 widely used products. Guest authorship was documented in 55 articles on sertraline [Zolof], which appeared in biomedical journals with high impact factors between 1998 and 2000… Seven publications on gabapentin [Neurontin], extolling the off-label use of the drug for pain and psychiatric conditions, were traced to a medical communication company.
It’s good to see Paxil Study 329 getting its well deserved recognition. Maybe notoriety will finally nudge the JAACAP towards retraction where direct appeals have failed:
Occasionally, ghost- and guest-authored studies mislead the health care community and violate public trust. To promote the off-label use of paroxetine [Paxil] for treating depression in adolescents, the manufacturer manipulated clinical trial data to ensure that the drug met efficacy and safety requirements. A publication guest authored by Martin Keller in the Journal of the American Academy of Child and Adolescent Psychiatry extolled paroxetine as generally well tolerated and effective for treating major depression in adolescents. Recently, the manufacturer admitted that the Keller paper was part of a fraud and agreed to pay a $3 billion fine for marketing paroxetine and other drugs…
In the following, it’s good to see that there are specific moves afoot to put a big damper on guest- and ghost-writing. The minority of us who follow these developments can spot it quickly, but the overwhelming majority of readers don’t seem to know know that they’re reading industry generated propaganda inserted into our literature by our academic colleagues for a price, and that the listed authors may have had nothing at all to do with the design and conduct of the study, its analysis, the writing, or even its conclusions, a shameful misuse of their academic credentials and their universitys’ reputations. It should be grounds for demotion or dismissal in my humble opinion:
The landscape is changing with respect to the publication of industry-sponsored clinical studies. Industry has conceded that the credibility of clinical studies has diminished because of reported ghost and guest authorship and the disclosure of biased or selective results. A working group of industry representatives and biomedical journal editors recently published sweeping recommendations that would enhance the transparency and credibility of industry-sponsored clinical studies [Mayo Clin Proc. 2012 May; 87(5): 424–429. full text on-line] [Uniform Requirements for Manuscripts Submitted to Biomedical Journals]. One recommendation is that industry should move to a zero tolerance position on ghost and guest authorship. At the present time, only 6 [Amgen, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, and Pfizer] of the 108 pharmaceutical companies registered in the US have published corporate guidelines and work practices that increase transparency, prevent ghost and guest authorship, as well as abuse of the peer review system. The working group also recommended that guest authors be given full access to study design, the raw data from a study, and the data analyses so that a guest author can attest to study validity. To reduce the underestimation of adverse effects and health risks, the group also recommended that all adverse effects and risks be reported in a transparent and clinically relevant manner…

Although the ICMJE, the World Association of Medical Editors, and the Committee on Publication Ethics have declared ghost and guest authorship to be “dishonest and unacceptable,” journal editors have not changed publication paradigms. Only 29% of 324 biomedical journals use, endorse, or adhere to the ICMJE guidelines. Of the 79 journals that compose the Pharmacy Library Core Journal List, only 33% adhere to or endorse the ICMJE authorship guidelines. Listing of authors’ contributions to a study is required by only 9% of 324 biomedical journals and 18% of the core pharmacy journals. Most biomedical journals require identification of the funding sources. However, it is unclear whether industry funding is an in-kind payment from the sponsor or its agents to individuals associated with the subject of the article, funding of future research in the guest author’s laboratory, or both. Few journals require authors to take responsibility for the scientific validity of a study
In 2000, Dr. Marcia Angell, then editor of the New England Journal of Medicine wrote a nuclear editorial, Is Academic Medicine for Sale? It was stimulated by an article in that issue of the NEJM by Martin Keller et al with 29 authors, many of whom we still know of as the upper level of the KOL/COI cohort [see has to stop…]. It was a valiant effort on Dr. Angell’s part and it would lead her to many other such publications, but unfortunately, the answer to her question remains "yes!"

In the last month, there have been posts on this blog about ghost-written articles by four of the authors on that paper Dr. Angell was complaining about thirteen years ago [Trivedi, Thase, Rush, Keller] [as it should be…, objectively… seroquel: good to the last drop…] and another who was reporting on an offshoot of that same old paper promoting data that had been long since retracted [Nemeroff] [has to stop…]. Industry funded ghost written articles in major journals remain an every issue problem in spite of some of publicity and progress reported above.

Zero tolerance seems like the only viable solution and it will have to be enforced by editors, authors, journals, and the universities to be stopped. It’s apparently too lucrative to the guests and their industry sponsors to expect common decency and respect for science to carry the day. Zero tolerance will mean that heads will need to roll, and we aren’t yet in a place to expect that will happen in the near future. The irony is that the last several posts were about a lofty debate in 1990 about the sanctity of clinical trials and evidence based medicine [down the rabbit hole…], and here we are only ten years later talking about jury-rigged clinical trials with just-pretend authors…
  1.  
    Steve Lucas
    July 9, 2013 | 8:53 AM
     

    It is important to remember that the total economic cost of these papers is not limited to the total sales of the drug or devices listed. The true economic cost is some multiple as we need to consider the cost of travel and time for office visits, complication cost, including hospital stays and additional medication, as well in psychiatry the cost of supervising a distraught patient.

    In conversations with GP’s I am told they do not have time to read articles but instead rely on the publisher and abstract to determine which drugs they will use. These are often furnished by the drug reps whose solution to a drug not achieving the desired results is to demand higher doses and blame the patient for somehow not responding to treatment.

    Rarely do we see a drug removed from a patient’s regiment; instead drugs are simply added until we see patients with 20 or even 30+ medications per day. Add in an ever increasing diet of pain medications and patients of all types are consuming more and more time of friends and family as they deal with psychological and physical problems caused by what may have started with the use of one medication.

    A crazy payment system and drive to up code for additional income drives medicating patients to assure a 90 day office visit cycle. The DSM-V will only encourage this behavior as it becomes easier for those “country doctors” to venture into the area of antipsychotics and mood altering drugs.

    Steve Lucas

  2.  
    July 9, 2013 | 9:26 AM
     

    Steve,
    These are often furnished by the drug reps whose solution to a drug not achieving the desired results is to demand higher doses and blame the patient for somehow not responding to treatment… Rarely do we see a drug removed from a patient’s regiment; instead drugs are simply added until we see patients with 20 or even 30+ medications per day.

    Excellent points all. Working in a rural charity clinic, I am awed at the number of medication people show up taking. Complaints of continued symptoms are met with increased doses or new drugs until pills are more like a food group than a treatment. It’s not easy to reverse the process. The medications seem to validate the patient’s complaint and giving them up [besides withdrawal symptoms] is removing that validation.

    If I’ve learned something new in my retirement volunteer doctoring, it’s the art of stopping un-needed medications. The most useful tool I’ve found is taking a history of how and why the medications were added helps the patient see that they were started because the last one wasn’t working [without stopping the “last one”]. It also helps the patient see that I’m trying to help them rather than take something away from them. Once engaged, the next problem is which ones to stop. I generally try to start with the ones least likely to have withdrawal symptoms, because they often feel better stopping those drugs. The fun of it is that often these polydrug patients have things that they need to discuss, and those things just come up along the way – thing like a difficult child, a bad marriage, life things. I call it “country psychiatry.” It’s hardly what I did in my career, but I kind of enjoy it. Once I realized that these patients went to the doctor because they needed something, and got pills. If you give them what they needed in the first place, being heard or talking over a life problem, no matter how limited the time and contact, the pills are much easier to give up.

  3.  
    wiley
    July 9, 2013 | 11:06 AM
     

    On discontinuing multiple medications and the elderly:

    http://doctorskeptic.blogspot.com/2012/11/stop-medication-train-elderly-want-to.html

    The following news, I think makes it vital that risks and adverse effects of drugs be well documented and studied by independent agencies from the go.

    The Supreme Court ruled on Monday that generic drugmakers cannot be sued under state law for adverse reactions to their products, a decision that consumer advocates called a blow to patient safety.

    In a 5-4 vote, the court ruled for Mutual Pharmaceutical Co, owned by Sun Pharmaceutical Industries Ltd, overturning a multimillion-dollar jury award to a badly injured patient in New Hampshire who alleged a generic drug she had taken was unsafe based on its chemical design.

    The majority opinion, written by Justice Samuel Alito, said the state’s law could not run against federal laws on prescription medicines whose design has been approved by the Food and Drug Administration.

    http://www.reuters.com/article/2013/06/24/us-usa-court-generics-idUSBRE95N0RC20130624

  4.  
    wiley
    July 9, 2013 | 11:10 AM
     

    including the generic ones

  5.  
    Melody
    July 9, 2013 | 12:01 PM
     

    What will it take for doctors (not just mental health physicians) to realize that they have turned over their practice to insurance companies; and by relying on ‘detail men’ for their education, they have (or will) destroy their reputations as trusted healers. (Apologies, I know I am painting with a very broad brush.) When I first began following medical blogs and revelations about BigPharma, I became so skeptical of the medical “profession” that I took a holiday from healthcare . . . about a 10 year holiday. Sadly, with old age upon me, I decided to re-enter the arena, primarily because not only am I not getting younger, I am probably not getting healthier. Recognizing that I would need a gatekeeper to oversee my ‘golden years’, the problem became whether to select a GP who was young–and in all likelihood outlive me–or an older physician, who might necessitate several changes of caregiver.

    The lack of trustworthiness is probably not widespread. My children implicitly ‘trust their doctor’ (although I’m working hard to educate them). But if bloggers and a few in the media continue their educational efforts . . . maybe corporate physicians will re-think their place within the system, as well as their responsibility and allegiance to Hippocrates.

  6.  
    July 10, 2013 | 1:37 PM
     

    It used to be that minimizing the drug burden was good doctoring. What happened to that ethos?

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