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16 mayo, 2013

Call to action on selling sickness: final statement

Source: Call to action on selling sickness

The Selling Sickness conference of February, 2013 was designed to be part of a global progressive and activist health movement. A CALL TO ACTION statement can help unify professionals, researchers, activists, scholars, caregivers, advocates and all citizens alarmed by disease-mongering.
The statement below was shaped by many contributors and discussed at “Selling Sickness, 2013: People before Profits” in Washington, DC, In February, 2013.

CALL TO ACTION ON SELLING SICKNESS

Washington, DC

We come together as researchers, health care professionals, activists, advocates, patients, caregivers and citizens deeply troubled about the growing corruption of medical science and health care.
We demand an end to industry-promoted disease-mongering that manipulates health concerns and causes harm through practices that medicalise normal life and deceive professionals and the public.
Commercial imperatives are being allowed to corrupt clinical, research and marketing practices which now include hiding data, inflating diagnostic categories, unnecessary screening and treatment, deceptive marketing, faulty and biased research and publishing, inadequate oversight, a neglect of social factors and injustices, and uncritical, unbalanced reporting.
We are alarmed at how undergraduate and post-graduate professional education are based on untrustworthy “science” designed to expand markets rather than impart valid knowledge or improve individual or public health.
Hazardous practices and distorted science harm patients, waste public resources, create illness and health anxiety, hoodwink the public, corrupt knowledge, corrode professionalism, and expose everyone to unnecessary, costly and dangerous tests and treatments.
Recognizing that we all will enact this commitment differently, we pledge our support to a new movement of alliances and actions to ensure that:

a clear firewall is created between industry/commercial influence, on the one hand, and, on the other, the regulators of drugs and devices as well as the developers and authors of clinical practice guidelines;
direct-to-consumer advertising of prescription drugs and medical devices is much more tightly regulated or, if possible, is prohibited and effective surveillance programs created;
drugs, diagnostic tests, and devices are tested, approved, reported and marketed solely with the goal of ensuring patient safety, scientific integrity and individual and public health;
drugs and devices are tested against appropriate controls, usually the current best treatment, in appropriate populations;
unsafe or ineffective marketed products are quickly identified, their harms and inadequacies are widely publicized, and they are removed from use;
all clinical trials are registered and access to all raw clinical trial data is made available for independent analyses at least at the time of approval, but preferably before approval;
the patent system for medicines is reformed so commercial benefit does not overshadow real clinical benefits for patients;
patients and health care consumers are fully informed about and involved in individual health decisions, as well as in research priorities, research design, and regulatory policy;
human subjects participating in clinical trials are adequately protected by ethical review boards that are functioning properly, accurate and complete informed consent, and the provision of full compensation for any harms;
journalists, whose job it must be to independently vet claims made by third parties, realize the harm that is done when news stories disseminate disease-mongering sales and promotion messages in an unchallenged, unverified manner;
health care regulations, health professional training, and clinical practice guidelines acknowledge and make allowance for marginalized and vulnerable groups who may be more susceptible to harms and exploitation;
the usually less profitable non-pharmaceutical treatments and therapies, as well as disease prevention and community-centered interventions, are raised in research and publishing priority to levels comparable to drug and device therapies.

These reforms will substantially improve public health and safety in a complex world of escalating technologies and communications media, and will save money, thereby lessening pressure on individual and public budgets and private health insurance programs.
We believe the urgent threat to human health from disease-mongering requires the united and creative action of citizens and professionals.
We pledge ourselves to act, individually and collectively, to distribute and to implement the measures outlined in this statement and encourage continuing outreach to interested others.

PLEASE SIGN THE STATEMENT TO INDICATE YOUR ENDORSEMENT.

JOIN OUR GLOBAL MOVEMENT!

13 mayo, 2013

Antithrombotic Therapy and Prevention of Thrombosis,9th ed: American College of Chest Physicians

Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guideline

Gordon H. Guyatt , MD, FCCP ; Elie A. Akl , MD, PhD, MPH ; Mark Crowther , MD ;

David D. Gutterman , MD, FCCP ; Holger J. Schü nemann , MD, PhD, FCCP ; for the American

College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel*
CHEST 2012; 141(2)(Suppl):7S–47S

Full Text

The eighth iteration of the American College of Chest Physicians Antithrombotic Guidelines presented, in a paper version, a narrative evidence summary and rationale for the recommendations, a small number of evidence profiles summarizing bodies of evidence, and some articles with quite extensive summary tables of primary studies. In total, this represented 600 recommendations summarized in 968 pages of text. Many readers responded that the result was too voluminous for their liking or practical use.

Cognizant of this feedback, we worked hard to minimize the length of the text for the ninth iteration of the guidelines Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) without sacrificing key content. A number of topic editors found our shortening edits draconian, but we were determined to produce the leanest product possible.

There were, however, a number of obstacles. In what we believe is a key advance in AT9, we conducted a systematic review of what is known about patients’ values and preferences regarding antithrombotic therapy and included the results as an article in AT9. In another forward step, we recognized the problems with asymptomatic thrombosis as a surrogate outcome, and devised strategies to estimate reductions in symptomatic DVT and pulmonary embolism with antithrombotic prophylaxis. We felt it important to explain this innovation to users of AT9, and this meant another article.

We included, for the first time, an article on diagnosis addressing patients with symptoms and signs suggesting DVT. We increased the range of interventions we have covered, resulting in additional recommendations. Finally, we produced many summary of findings tables, which offer extremely succinct and informative presentations of best estimates of effect and the confidence associated with those estimates.

If published in the same fashion as the Antithrombotic and Thrombolytic Therapy, 8th ed: American College of Chest Physicians Antithrombotic Guidelines, this would have resulted in a document with > 850 pages of paper text, an unacceptable length. Given this and with the advice of the journal, we decided to adopt a highly focused print version that includes only this executive summary and the following articles:

An introduction describing the major innovations in AT9
A methods article explaining how we developed the guidelines (a potential model for other guideline groups interested in optimal rigor)
Recommendations and grading from each article embedded in the table of contents of each article

Those seeking the rationale for the recommendations, including the supporting evidence, should access the online version of the guideline (http://http://chestjournal.chestpubs.org/content/141/2_suppl) that includes a narrative summaries and supporting summary of findings tables. The numbering indicated beside the recommendations in this summary is aligned with the sections and tables found in the full articles. Those interested in a deeper understanding of the evidence can turn to online data supplements for each of the articles that include recommendations. There, they will find evidence profiles (expanded versions of the summary of findings tables) and some tables summarizing the methods and results, and the risk of bias, associated with the individual studies that contributed to the evidence profiles and summary of findings tables.

The world of medical information is rapidly becoming a world of electronic storage and presentation of primary studies, recommendations, and a wide variety of other information of interest to health care practitioners. Although our abbreviated paper copy presentation represents a necessary response to a challenging situation, it is also a harbinger of the increasingly electronic world of medical information into which future editions of guidelines are destined to move.

Go to:

Summary of Recommendations

Note on Shaded Text: Throughout this guideline, shading is used within the summary of recommendations sections to indicate recommendations that are newly added or have been changed since the publication of Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Recommendations that remain unchanged are not shaded.