I have developed a reflex high alert whenever treatment algorithms or treatment guidelines are on the table. I’m sure my head is as filled with algorithms as any doctor, but I’m suspicious of them coming from the outside. They can be a way to “push” drugs for one thing. But they also can make people careless.
by Jeanne Lenzer, medical investigative journalistBMJ 2013;346doi: http://dx.doi.org/10.1136/bmj.f3830 [Published 14 June 2013]
…Guidelines are usually issued by large panels of authors representing specialty and other professional organisations. While it might seem difficult to bias a guideline with so many experts participating under the sponsorship of large professional bodies, a worrying number of cases suggests that it may be common. A recent survey found that 71% of chairs of clinical policy committees and 90.5% of co-chairs had financial conflicts. Such conflicts can have a strong impact: FDA advisers reviewing the safety record of the progestogen drospirenone voted that the drug’s benefits outweighed any risks. However, a substantial number of the advisers had ties to the manufacturer and if their votes had been excluded the decision would have been reversed.Biased guidelines can have powerful and wide ranging effects. Thousands of guidelines have been issued, and, when promulgated by highly respected professional societies, they sometimes serve as de facto “standards of care” that may be used to devise institutional protocols, to develop measures of physician performance, and for insurance coverage decisions. Guidelines may influence the medicines selected for inclusion on drug formularies and may be used as a “reliable authority” to support expert testimony in malpractice suits. Eighty four per cent of doctors say they are concerned about industry influence over clinical guidelines, yet the fear of malpractice suits puts many in an untenable position of following guidelines they believe are flawed or dangerous to patients. Despite repeated calls to prohibit or limit conflicts of interests among guideline authors and their sponsors, most guideline panellists have conflicts, making the guidelines they issue less than reliable…
I recall a time in my training when I had a little black notebook [we called the "ectopic brain"] with all kinds of protocols, algorithms, guidelines written in to remind me of all the things that needed doing in specific situations. They weren’t injunctions, just guides for a novice. Things like what to do for Pulmonary Edema, Diabetic Coma, the Acute Abdomen, Septic Shock, etc. My head and my book were full of such things. Then there were real guidelines pasted cut out and pasted in like the ADA recommendations for Diabetic Management or the work-up for hypertension and treatment guidelines. It was a book for the Intern I was and it disappeared by the end of the year, to be seen no more. My point being that part of what’s called experience is an internal collection of algorithms and guidelines gathered by anyone, doctor or auto mechanic, over the course of a professional life.
But this article is about something else. It’s about expert guidelines put together by biased experts – and it gives concrete examples of instances where those guidelines have been heavily compromised by the industry ties of the authors – examples resulting in unnecessary treatment and actual increased mortality. In psychiatry, there are plenty of examples – like the whole Texas Medical Algorithm Program [TMAP] that has never been fully exposed. If you’ve read this blog much, you’ve probably noticed that I have been unusually vigilant about the publications of Dr. Madhukar Trivedi like the last several posts. It’s because of his fixation on algorithms and guidelines. When I looked into the source for the algorithms in these computerized systems below, I never found them. They were just what he and unknown others thought. It was the same for TMAP or STAR*D. Opinions:
|1.||Computerized medication algorithms and decision support systems in major psychiatric disorders.
Trivedi MH, Kern JK, Baker SM, et al:
Journal of Psychiatric Practice 6:237–246, 2000
|2.||Computerized medical algorithms in behavioral health care, in Behavioral Health Care Informatics.
Trivedi MH, Kern JK, Voegle T, et al:
Edited by Dewan NA, Lorenzi N, Riley R, Bhattacharya SR. New York, Springer-Verlag, 2001
|3.||Development and implementation of computerized clinical guidelines: barriers and solutions.
Trivedi MH, Kern JK, Marcee AK, et al:
Methods of Information in Medicine 41:435–442, 2002
|4.||A Computerized Clinical Decision Support System as a Means of Implementing Depression Guidelines.
Trivedi MH, Kern JK, et al:
Psychiatric Services 55:879–885, 2004
|5.||Assessing physicians’ use of treatment algorithms: Project IMPACTS study design and rationale.
Trivedi MH, Claassen CA, et al:
Contemp Clin Trials. 28(2):192-212, 2007
|6.||Barriers to implementation of a computerized decision support system for depression: an observational report on lessons learned in "real world" clinical settings.
Trivedi MH, Daly EJ, Kern JK, et al:
BMC Medical Informatics and Decision Making, 9:6, 2009
|7.||A computerized decision support system for depression in primary care.
Kurian BT, Trivedi MH, Grannemann BD, et al:
Primary Care Companion, Journal of Clinical Psychiatry,11(4):140-1466, 2009
|8.|| Using algorithms and computerized decision support systems to treat major depression.
Shelton RC and Trivedi MH:
Journal of Clinical Psychiatry,72(12):e36, 2011
Madhukar H. Trivedi is or has been an advisor/consultant to, or on the Speakers’ Bureaus within the past 3 yr and anticipates receiving fees in the near future for: Abbott Laboratories, Inc., Abdi Ibrahim, Akzo [Organon Pharmaceuticals Inc.], Alkermes, AstraZeneca, Axon Advisors, Bristol-Myers Squibb Company, Cephalon, Inc., Eli Lilly & Company, Evotec, Fabre Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica Products, LP, Johnson & Johnson PRD, Libby, Lundbeck, Meade Johnson, MedAvante, Medtronic, Naurex, Neuronetics, Otsuka Pharmaceuticals, Pamlab, Parke-Davis Pharmaceuticals, Inc., Pfizer Inc., PgxHealth, Rexahn Pharmaceuticals, Sepracor, SHIRE Development, Sierra, SK Life and Science, Takeda, Tal Medical/ Puretech Venture, Transcept, VantagePoint and Wyeth-Ayerst Laboratories. In addition, he has received research support from: Corcept Therapeutics, Inc., Cyberonics, Inc., Merck, Novartis, Pharmacia & Upjohn, Predix Pharmaceuticals [Epix], Solvay Pharmaceuticals, Inc., Targacept and Valient.
In the early 1990s, high dose steroids became the standard of care for acute spinal cord injury, reinforced by a Cochrane review. The Cochrane Collaboration, is widely known to have strict standards concerning conflicts of interest, yet in this case the collaboration permitted Michael Bracken, who declared he was an occasional consultant to steroid manufacturers Pharmacia and Upjohn, to serve as the sole reviewer. He was also the lead researcher on the single landmark study, published in the New England Journal of Medicine, used to support the Cochrane review.
Neurosurgeons were not convinced. Many expressed concern about high rates of infection, prolonged hospital stays, and death with high dose steroids. One expert estimated that more patients had been killed by the treatment in the past decade than died in the 9/11 World Trade Center attacks. A poll of over 1000 neurosurgeons showed that only 11% believed the treatment was safe and effective. Only 6% thought it should be a standard of care. Yet when asked if they would continue prescribing the treatment, 60% said that they would. Many cited a fear of malpractice if they failed to follow “a standard of care.”That standard was reversed this March, when the Congress of Neurological Surgeons issued new guidelines. The congress found that, “There is no Class I or Class II medicine evidence supporting the benefit of [steroids] in the treatment of acute [spinal cord injury]. However, Class I, II, and III evidence exists that high-dose steroids are associated with harmful side effects including death”…
Concern about the credibility of guidelines led the Institute of Medicine to recommend that ideally no guideline authors should have financial conflicts of interest. If individuals who have professional conflicts that can’t be divested [for example, specialists whose career depends on treating a certain condition] are included, the institute recommends that they “should represent not more than a minority” of the panellists.