Anyone reading a scientific paper in a reputable journal which uses a peer-review system expects the information to be reliable and objective. Unfortunately this is not necessarily the case because there is now convincing evidence that the pharmaceutical industry devotes huge resources to influencing the way in which the material is presented with particular reference to the conclusions. Following court cases in the USA drug companies have been required to disclose documents which reveal that ghost writing and guest authorship is now common practice.

Ghost writing exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. It often occurs simultaneously with guest authorship (sometimes called honorary or gift authorship), where the contributions of the named authors are very limited, or non-existent (1). The prime purpose of these strategies is to ensure that the benefits of any drug involved in the research are presented in the best possible light and that any undesirable side-effects are minimized. Most of the hard work preparing the manuscripts is done by professional writers whose name may not even be included as an author. Those listed officially as authors are usually well-known in the field and are used primarily to lend credibility to the paper. According to Jerome Kassirer, a former chief editor of the New England Journal of Medicine:

“Ghost writing debases fundamental tenets of the medical profession. It violates authors’ personal integrity, responsibility, and accountability. More importantly, ghost writing threatens the very fabric of science and thus the validity of our medical knowledge, and in doing so it jeopardizes patient care.”(1)

He refers to one specific example in which the marketing department of a pharmaceutical company promoted one of its products by carefully selecting positive reports and playing down any risks. It then made an agreement with a reputable academic to be paid a fee to submit the paper to a journal under his own name (2).

Richard Smith, a former editor of the British Medical Journal, and a colleague concluded that:

The way medical journals publish the results of clinical trials has become a serious threat to public health” (3).

In their opinion, clinical investigators have become adept at selecting results favourable to their paymasters, very often pharmaceutical companies, which are used by them to promote their products. As a consequence the researchers profit financially and advance their careers. The editors are provided with material to publish and the companies/organisations which own the journals are profitable. The losers are the trial participants whose contribution to research is wasted, the patients who must swallow the drugs despite the distorted evidence, and the public who must pay for the drugs.

As an example of what is happening is that unfavourable results may be excluded or removed from the paper that is subsequently published. By contrast, favourable results may be published many times (cloning) and then subject to intensive marketing to ensure that they get noticed.

CASE STUDY

As a result of litigation about Hormone Replacement Therapy (HRT) the Wyeth pharmaceutical company had to release 1500 documents which have been analyzed to provide valuable insight into these issues (4).

HRT was approved in 1995 and promoted on the grounds that the treatment would prevent cardiovascular disease (CVD), osteoporosis, Alzheimer’s Disease, colon cancer, tooth loss, and macular degeneration. However in 2002 the Women’s Health Initiative (WHI) demonstrated conclusively that HRT failed to prevent CVD. It was also discovered that it increased the risk of breast cancer and stroke. Further analyses showed that HRT increased the risk of dementia and incontinence.

The documentation revealed that companies devote considerable resources to the preparation and publication of articles in the medical journals as well as posters for display at meetings in order to establish key marketing messages. It is common practice to employ specialist companies in education and communications to create the papers and get them placed in journals and magazines that will be read by those in the medical professions.

With respect to HRT, Wyeth engaged DesignWrite, whose role was to help the company decide what data to present, recruit “authors”, choose journals, create abstracts for meetings with the object of positioning the product appropriately to influence those responsible for prescribing. Between 1997 and 2003 DesignWrite produced over 50 peer-reviewed papers and more than 50 scientific abstracts and posters, journal supplements, internal white papers, slide kits and symposia.

The analysis of the disclosed papers came to the conclusion that DesignWrite helped Wyeth create ghostwritten reviews and commentaries which were to:

  • Mitigate perceived risks of hormone-associated breast cancer
  • Promote unproven, off-label uses, including prevention of dementia, Parkinson’s Disease and visual impairment
  • Raise questions about the safety and efficacy of competing therapies
  • Defend cardiovascular benefits, despite lack of reliable evidence to support this position
  • Position low-dose hormone therapy

Despite the fact that the WHI had established that HRT did not prevent CVD, stroke or Alzheimer’s Disease, other benefits were devised and promulgated. It was suggested that HRT treatment was repeatedly shown to increase collagen content, dermal thickness and elasticity. Many ghost written articles questioned the link between HRT and breast cancer or falsely implied that breast cancers associated with HRT are less aggressive.

The insight gained from these studies is truly alarming and demonstrates the extent to which information is being manipulated in order to promote the sales of drugs of doubtful efficacy. There is a total failure to apply any kind of ethical or socially responsible standards. Essentially it means that not only are members of the public being defrauded but that they may also experience serious damage to their health.

It is highly significant that when this case study was published in 2010 many doctors were still prescribing HRT to menopausal patients even though there was sound evidence of its danger. The author concluded that:

This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.”

 

REFERENCES

  1. P C Gøtzsche, J P Kassirer, K L Woolley, E Wager, A Jacobs, A Gertel, C Hamilton (2009)
    http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000023
  2. J S Ross et al (2008) Journal of the American Medical Association 229 (15) pp-1812-1800
  3. R Smith and I Roberts (2006)   http://www.plosclinicaltrials.org/article/info%3Adoi%2F10.1371%2Fjournal.pctr.0010006
  4. A J Fugh-Berman  (2010) http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000335