Ghosts of Vioxx Past: Medical Writing Under Attack
Vioxx may be gone from the market but the litigation against Merck rages on and consultants for the plaintiff (Ross et al.) have written an article exposing “guest authors” and “ghost writing” practices in publications concerning rofecoxib (Vioxx).
I cringe every time the term “ghost writing” comes up in connection with the medical and scientific writing profession. Are we really “ghost writing” when we, medical writers, draft manuscripts for clients in the pharmaceutical industry? Is this unethical? Let’s see what the experts say.
Citing Rennie et al. (1994), Ross et al. defined ghost writing as “failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript.”
According to the World Association of Medical Editors (WAME), “ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself.” However, it is not quite clear where the role of the medical writer should be mentioned in the manuscript.
The International Committee of Medical Journal Editors (ICMJE) is much clearer with its guidelines which provide that “authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.”
Based on the ICMJE criteria, most medical writers clearly do not qualify for authorship. So where does the role of the medical writer come in? ICMJE states that “all contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.”
I, therefore, object to Ross et al.`s definition of “ghost writing” in their paper as non-compliant ICMJE`s guidelines.
The paper also referred to “an industry specializing in medical writing” as if this is something new. Though are no figures available, it is quite a common and accepted practice in the healthcare and pharmaceutical industry to employ the services of professional writers to write press releases, educational materials, clinical documents, submission dossier, and yes – scientific papers.
The American Medical Writers Association (AMWA has been in existence since 1940 and the European Medical Writers` Association (EMWA) since 1989. These organizations have established guidelines and code of conduct. Members of these organizations have drafted and proposed the “Good Publication Practice (GPP): Guidelines for Pharmaceutical Industries.”
Ross et al.`s article, although aimed to question the credibility of Merck, also placed medical writers in a bad light. Whereas the article gives the number of papers with financial disclosures, it does not give the number of papers which acknowledged the use of medical writing services as provided for in the ICMJE guidelines.
I do not condone data manipulation as well as blatant misleading publication strategies such as the examples cited by Ross et al. as having been practiced by Merck. I simply want to defend medical writing as a valid profession.
Medical writers play an important role in the drug development process. Clinicians and biomedical scientists are busy people. As chief investigators and head of laboratories, they do not have the time to sit down and write papers.
In the academia, writing is usually delegated to PhD students and postdocs. In the pharmaceutical industry, writing is mainly done by trained and accredited medical writers who may be in-company or on-contract. Based on data provided to us, we try to write the text to the best of our ability. In the process the health care industry is benefited by fast and timely publication of scientific information which could be crucial to public health.
According to a statement drafted by several AMWA members
“We believe that medical writers are valuable to the writing process and can facilitate and speed the publication of important scientific information. Professional writers ensure that the literature cited is current; the study and statistical methods are complete, appropriate, and adequately detailed; and the author’s interpretation of the study findings is clearly and concisely communicated. Because of their contributions, manuscripts may be reviewed more easily by peer reviewers with fewer queries to be answered before final acceptance.
Medical writers have an important role in conveying valuable information to physicians and others in both a clearly communicated and a timely manner.”
However, as medical writers, we also have the duty to maintain the ethical standards of our profession. We can do these by
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advising our clients on GPP especially in authorship and acknowledgement of medical writing services rendered.
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refusing to take part in or condone data manipulation and other scientific misconduct.
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advising our clients on complete transparency by conflicts of interest and financial involvement.
Only then can we stand and lift our heads proudly to declare that we are not “ghost writers”, but professional medical writers.
References:
Joseph S. Ross, Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and Ghostwriting in Publications Related to Rofecoxib A Case Study of Industry Documents From Rofecoxib Litigation. JAMA 299:15, April 16, 2008.
D Rennie, A Flanagin. Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin. JAMA 271: 469 - 471. Feb 1994.
E Wager, EA Field, L Grossman. Good publication practice for pharmaceutical companies. Curr Med Res Opin. 2003;19(3):147-8
Pediatric clinical trials: damned if you do, damned if you don’t
Drug regulators are in a quandary. On the one hand, they’d rather spare children from being used as test subjects in clinical trials. On the other hand, recent developments show an urgent need for pediatric testing.
There have been recent reports of adverse side effects, some of them fatal, attributed to OTC drugs for children. These concerned seemingly innocuous cough and cold medications containing active ingredients such as pseudoephedrine, paracetamol [1,2], and camphor [3]. But prescription drugs for children`s ailments such as asthma and ADHD are incriminated as well.
This brought to light how very little we actually know about pediatric pharmacology.
The problem lies with the fact that many drugs with well-established efficacy and safety profile have only been tested in adults. With an aging population and low birth rates in developed countries, the pediatric drug market is not really top priority for pharmaceutical industries. Very little money is allocated for pediatric R&D. Pharmacological results were simply extrapolated to pediatric population as “miniature adults.”
The issue is compounded by lack of test subjects. Very few parents in developed countries would ever consent that their children be enrolled in a clinical trial. Most pharmaceutical companies turn to developing countries for testing. Although there are strict guidelines regulating pediatric testing, there are still concerns about adherence to GCP in those countries.
The regulators are now scrambling to come up with solutions to plug this knowledge gap on pediatric drugs.
Last year, the US passed the Best Pharmaceuticals for Children Act 2007 and an amended version (2007) of the 2003 Pediatric Research Equity Act. The Acts empowered the US FDA to require drug companies to test new drugs on children before approval [4]. However, there is still a lack of knowledge on drugs approved before 2003.
In Europe, the EMEA is requiring a pediatric investigation plan for all new drug applications starting July 2008 (unless a non-pediatric use waiver is justified). In addition, it is funding research on off-patent drugs as well as looking into pediatric clinical data that may not have been previously published [5, 6].
In the meantime, millions of children need medications while drugs against cancer, infections, asthma, high blood pressure and hyperactivity currently available are waiting to be tested for pediatric use. Do we use these drugs or not ? Quandary for doctors and parents as well.
Damned if you do. Damned if you don’t.
References:
1. Wingert WE, Mundy LA, Collins GL, Chmara ES. Possible role of pseudoephedrine and other over-the-counter cold medications in the deaths of very young children. J Forensic Sci. 2007 Mar;52(2):487-90.
2. Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications–two states, 2005. Morb Mortal Wkly Rep. 2007 Jan 12;56(1):1-4.
3. Press Release, NYC Department of Health. January 17, 2008. Health department warns parents to keep camphor products away from children.
4. US FDA, Pediatric Drug Development. Retrieved 27 Jan 2008.
5. Sinha G.J. EU law mandates drug testing in children. J. Natl Cancer Inst. 2008 Jan 16;100(2):84-5.
6. EMEA Press Release Paediatric Committee (PDCO), 25 Jan 2008.
Clinical predictors of severe illness in neonates
In a multinational study, researchers evaluated 3177 aged 0-6 days old and 5712 infants aged 7 to 59 days old admitted to healthcare centers in Bangladesh, Bolivia, Ghana, India, Pakistan, and South Africa. They recorded the clinical signs and symptoms and evaluated the “sensitivity, specificity, and odds ratio (OR) for each symptom and sign individually and combined into algorithms to assess their value for predicting severe illness.” Jaundice was excluded in the analysis.
Results showed 12 independent clinical predictors of severe illness that would indicate the need for hospitalization in the 0–6 days age-group. These clinical signs are as follows:
1. History of difficult feeding
2. History of convulsions
3. Movement only when stimulated
4. Fast respiratory rate (≥60)
5. Severe chest indrawing
6. Pyrexia (>37.5 °C)
7. Low body temperature (<35.5)
8. Lethargy
9. Prolonged capillary refill
10. Grunting
11. Cyanosis
12. Stiff limbs
These predictors were also shown to be sensitive in the older age group.
To simply decision-making for primary care practitioners, the number of clinical signs indicative of the need for hospitalization was reduced, taking into account only the first seven in the list. This reduction did not significantly reduce the sensitivity of the check list.
Source:
Clinical signs that predict severe illness in children under age 2 months: a multicentre study. The Young Infants Clinical Signs Study Group. The Lancet 2008; 371:135-142.
Limits on MRI Use in the EU postponed
The EU decided to postpone introducing a law regulating workers’ exposure to electromagnetic fields [1]. The decision is based on the fact that such as legislation would place serious limits on the use of magnetic resonance imaging (MRIs).
Directive 2004/40/EC was aimed to protect workers against the occupational hazard of electromagnetic field exposure and was to take effect in April 2008 [2]. However, the high occupational limit values set by the directive would inadvertently put a ban on the use of MRI in diagnostic medicine.
“MRI is currently the leading technique for detecting brain tumours and many other serious conditions. It allows doctors to help 8 million patients each year…[the EC] is well aware of the enormous benefits of MRI and of its immense value for public health.” [1]
Other international agencies such as the International Commission on Non-Ionising Radiation Protection (ICNIRP) and the World Health Organisation (WHO) are looking into revising the current occupational limit values for electromagnetic fields [1]. The EU will probably introduce a revised directive based on similar limits in 2012.
In the meantime, the EU is pushing for more research in this field. It is funding projects under the 7th Framework Programme for Research to explore hybrid imaging systems such as MRI/PET and MRI/Ultrasound [1].
Sources:
[1] EU Press Release 26/10/2007. Commission to postpone and amend electromagnetic fields legislation to protect MRI Reference: IP/07/1610.
[2] Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004. Official Journal of the European Union L 159.
Diagnosing and managing lower back pain: New Guidelines from ACP/ACS
Earlier this month, a series of articles in the Annals of Internal Medicine covered the pharmacologic and nonpharmacologic management of lower back.
Systematic reviews [1,2] of English-language studies included in MEDLINE and the Cochrane Database of Systematic Reviews were conducted to assess the most common pharmacologic [2] and nonpharmacologic [1]interventions indicated for acute or chronic back pain. Based on these reviews, the American College of Physicians (ACP) and the American Pain Society (ACS) recommended a Joint Clinical Practice Guideline [3]. Some of the main points of the guideline are as follows:
Clinicians should conduct a thorough physical exam and medial history review to categorize patients into 1 of 3 broad categories, namely:
· “nonspecific low back pain
· back pain potentially associated with radiculopathy or spinal stenosis,
· back pain potentially associated with another specific spinal cause.”
In patients with nonspecific low back pain, imaging tecnhiques and other diagnostic tests shouldn’t be routinely used. These techniques should only be performed “when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination.” MRI seems to be the preferred method to check for radiculopathy or spinal stenosis while CT-scan is only recommended for patients who are “potential candidates for surgery or epidural steroid injection.”
Recommended first-line medications are paracetamol and NSAIDS.
Clinicians should also advise patients on effective self-care options as well as nonpharmacologic adjunct therapies like exercise, acupuncture, massage, spinal manipulation, yoga, or progressive relaxation.