Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Uncertainty is the only certainty in patient care.
- BM Hegde (3 December 2005)
-
Can we consider delinking industry from funding trials?
- Rajesh Chauhan (5 December 2005)
-
Re: "In Praise of Uncertainty."
- Hilary Butler (6 December 2005)
-
Re: Can we consider delinking industry from funding trials?
- Dr. Rajesh Chauhan (19 November 2007)
|
|
|||
|
BM Hegde, Retd. Vice Chancellor Mangalore-575 004, India
Send response to journal:
|
Dear Editor, The war against cancer has not been won; not likely to be won in the foreseeable future as well. All new drug trials are beset with similar problems of uncertainty. Even when an established treatment is given to any patient there is no guarantee that it will work the way the trials have demonstrated, as each individual is different from the other. Hippocrates did note that it is as important, if not more, to know the patient rather than the disease before embarking on the management. In the linear reductionist paradigm there is no salvation for this dilemma of uncertainty. Yours ever, bmhegde Competing interests: None declared |
|||
|
|
|||
|
Rajesh Chauhan, Consultant, Family Medicine & Communicable Diseases 309/9 A.V. Colony, Sikandra, Agra -282007. INDIA.
Send response to journal:
|
Dear Editors, Your editorials touch raw nerves and it has been done very well yet again [1]. Be it cancer or any other illness, parents or for that matter any one that indeed cares, gets worried. We on our part as doctors do want to advise only the best remedy to our patients. But are we confident enough, or must we be so naïve and complacent, to outright believe the sure shot claims held by a new miracle drug? Conflict of interests is a serious problem which has eroded the credibility of research. As a solution, can we consider having a totally unbiased and a qualified analysis/rejoinder by a hand picked team of professionals, with impeccable records, on the distinctive features and merits of any new drug and its utility over and above the established and time tested drugs. Rather than allowing interested agencies or companies to foot the bills directly, funds required to carry out independent analysis be rather allocated from a reserve specifically set up for this purpose, in order to set aside the vulnerability. A common pool of funds can easily be formed from a small percentage of tax collected from all pharmaceutical companies for this purpose [3]. Nearly all countries would have their own competent medical bodies which can govern this pool of funds and they can also nominate eminent professionals, depending on their competencies, for vetting new products. Funding of analytical research this way shall be free of the stigma of being free of all competing interests. Results would therefore be more reliable and definite. Medical fraternity as well as patients (and likewise parents of sick children, in this case) can therefore be more confident of the likely outcomes. Pharmaceutical industry will also be benefited by way of less spending on advertisements, not having to fund a research directly, and more importantly of an assured, rapid and timely critical analysis of their products. Shortcomings of their products, if any, will also be made known for them so that needful corrections and modifications may be done, if feasible. This pool of funds can also allow us to decline free lunches [2], if only we are interested and determined, by using funds out of this very pool for funding seminars, conferences etc. A new beginning can always be made which can provide everyone a welcome break. Probably it is a time to start thinking where are the things going wrong and how to set them right besides considering possibilities on providing timely and reasonably accurate advice to the needy. With warm regards. References: 1. Fiona Godlee. In praise of uncertainty. BMJ 2005; 331: 0 ; doi:10.1136/bmj.331.7528.0-f 2. Fiona Godlee. Say no to the free lunch. BMJ 2005; 330: 0 ; doi:10.1136/bmj.330.7496.0-g 3. Chauhan R, Singh AK, Kushwah P. Conflict of interest: a probable way forward. JABFP 12 September 2005. http://www.jabfp.org/cgi/eletters/18/5/411#67 Competing interests: None declared |
|||
|
|
|||
|
Hilary Butler, freelance journalist home 1892
Send response to journal:
|
Fiona Godlee's discussion of cancer drug trials and the article in this issue, touches a nerve, that isn't fully discussed: >>>***Imagine that you have just been told that your child has cancer. As the news sinks in, you are likely to want to know what the best treatment is and to be assured that your child will get it. You may not want to hear that we don't know what the best treatment is and that the only way to find out for sure is to enter your child into a trial.***<<< To enter a child into a trial will not be the way "to find out for sure" about very much. >>>***So should you encourage parents to enrol their children into randomised trials? If the trials are publicly funded, this paper says that you should. For industry funded studies the answer is probably also yes, but look hard at the control treatment and at the outcome measures.***<<< No doctor should encourage parents to enrol their children into trials for the sake of providing study material. What parents need is a broader type of information. Books such as "Second opinions" By Dr Jerome Groopman, well acquainted with cancer drug trials, gives some insight into the fact that not only do many trials never make it past phase II or III, but also that some drugs that spectacularly fail in trials, appear to spectacularly succeed in some trailees. The problem is that the placebo effect of being in the trail and sometimes having a degree of "psychological transference" and "positive relationship" with doctors in a way that doesn't happen in normal medical practice, is never measured. And knowing as we do what a powerful "substance" placebo is, there is no way to judge whether the drug was the curative agent, or the additional element relationship, might have been the ultimate factor that enabled that person to find within themselves new mental skills and purpose to ensure their own survival. It could be, that the drug itself, was essentially "funny money" currency, and a by-line to the actual success. The uncertainty principle may in fact be, whether or not the child likes the principle study personnel, and whether or not they have a positive rapport and relationship. For all the talk about how hard it is to study alternative medicine, because of the "enhanced" relationships between the person and the practitioner, this same confounding variable applies to many drug or treatment trials. "Hope" comes in many shapes and forms, most of which can't be measured. That is something that parents need to appreciate in depth, over and above the brick and mortar facts about the chemicals their child will be subjected to: That the people who conduct the trials might be as important as the trial itself. Hilary Butler. Competing interests: None declared |
|||
|
|
|||
|
Dr. Rajesh Chauhan, CO & SEMO, MH Baroda, Gujarat, INDIA MH Baroda, Gujarat, INDIA -390008 (309/9 A.V. Parishad, Sikandra, AGRA. INDIA -282007)
Send response to journal:
|
Dear Editor, Kudos to BMJ once again. I was shaken up from slumber after having read a guest column appearing in ‘The Economic Times’ (of India) of 18 Nov 2007, which was attributed to Jeremiah Norris. It mentions that, “Now, the WHO’s new Draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (IGWG) aims to weaken intellectual property further and to bring research and development under the control of governments and international bodies”. This column also appears elsewhere [1]. The suggestions submitted as a ‘Rapid Response’ on 05 Dec 2005 [2] has probably been noticed and it goes without saying that the BMJ definitely brings about changes. Warm regards. Dr. Rajesh Chauhan References: 1. Jeremiah Norris. WHO might itself threaten world health. Projo.com/opinion/contributors/content/CT_norris8_11-08- 07_EC7NC40_v23.35a80d0.html. Accessed on 19/11/2007 2. Chauhan R. Can we consider delinking industry from funding trials? BMJ.com/cgi/eletters/331/7528/0-f#123099, accessed on 19/11/2007 Competing interests: None declared |
|||