Rapid Responses to:

EDITOR'S CHOICE: Jane Smith More research and better behaviour BMJ 2004; 329: 0-f [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

Both poor and rich world need unexpensive clinical methods for primary prevention.

Sergio Stagnaro   (19 November 2004)

Opportunities to test behaviour during research.

Trevor G Kerr   (23 November 2004)

Aripiprazole advertisement

Clive E Adams   (26 November 2004)

Both poor and rich world need unexpensive clinical methods for primary prevention. 19 November 2004
Sergio Stagnaro, Specialist in Blood, Gastrointestinal, and Metabolic Diseases. Researcher in Biophysical Semeiotics Via Erasmo Piaggio 23/8 16037 Riva Trigoso (Genova) Italy Send response to journal: Re: Both poor and rich world need unexpensive clinical methods for primary prevention.	Sir, I agree with your statement “Last week we had a theme issue on what the rich world could learn from the poor. This week, the cynics will say, it's back to normal: citizens of the rich world only really care about a poor world problem when it might affect them”. Indifferent of controlling pesticides and organophosphate poisoning, however, I’d prefer to teach both doctors and people of underdeveloped as well as developed countries “clinical”, useful methods, i.e., to use on very large scale for primary prevention, e.g., in the war against metabolic disorders, including “obesity” (sic!), but particularly type 2 diabetes (2, 3, 4), arterial hypertension (5), cancer by bed-side recognizing oncological terrain (4), a.s.o., without expense. Unfortunately, western people prefer sending and selling to poor, underdeveloped countries “old” technology, medicine and traditional medical knowledge rather than, e.g., the Biophysical Semeiotics (HONCode website 233736, www.semeioticabiofisica.it), that could allow clinical prevention, to a large extent, the most common and serious human diseases by recognizing at the bed-side, from birth, diverse constitutions (diabetic, dyslipidemic, hypertensive, arteriosclerotic, glaucomatous, lithiasic, ONCOLOGICAL, a.s.o.) (4, 6). 1) Smith J. More research and better behaviour. BMJ 2004;329 (20 November), doi:10.1136/bmj.329.7476.0-f 2) Stagnaro S., Stagnaro-Neri M. Valutazione percusso-ascoltatoria del Diabete Mellito. Aspetti teorici e pratici. Epat. 32, 131, 1986 3) Stagnaro S., Diet and Risk of Type 2 Diabetes. N Engl J Med. 2002 Jan 24;346(4):297-298. letter [PubMed –indexed for MEDLINE]. 4) Stagnaro Sergio, Stagnaro-Neri Marina. Introduzione alla Semeiotica Biofisica. Il Terreno oncologico”. Travel Factory SRL., Roma, 2004. 5) Stagnaro-Neri M., Stagnaro S., Stadio pre-ipertensivo e monitoraggio terapeutico della ipertensione arteriosa. Omnia Medica Therapeutica. Archivio, 1-13, 1989-90, 1990 6) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico- Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la definizione della Single Patient Based Medicine. Ediz. Travel Factory, Roma, 2004. http://www.travelfactory.it/semeiotica_biofisica.htm Competing interests: None declared
Opportunities to test behaviour during research. 23 November 2004
Trevor G Kerr, Medical Microbiologist Southern Health, 246 Clayton Road, Clayton VIC Australia 3168 Send response to journal: Re: Opportunities to test behaviour during research.	The Academy of Medical Sciences is calling for evidence in a study (1) to support the conclusions of its' 2003 report 'Strengthening Clinical Research' (2). That Report notes the barriers to medical research caused by legislation that has strengthened the requirements for informed consent, and it suggested the creation of a National Ethical Code. The proposal for a Code is an appeal to the public, as much as to medical scientists and bureaucrats. Therefore, it is curious that the Report acknowledges the "generous financial support" of GlaxoSmithKline, but there is no mention of the need to manage conflicts of interests. Perhaps the Academy will review its' position, in light of recent moves by Department of Health (3). Tighter regulations should make sure doctors on key advisory councils are unable to hide their financial relationships with industry. Para 2.21 of the Report states (p.21) "Patients registered in Phase III clinical studies on the whole do significantly better than those who are not involved. Phase III studies promote good clinical practice and have a widely beneficial effect on the quality of clinical activity." There is an opportunity to test these contentions. GSK is sponsoring a Phase III trial of a papillomavirus vaccine (4,5). Sexually active young women are being recruited. At the same time, the government is responding to the rising rates of sexually transmitted infections (STIs) (6) in this age group. It would be useful to audit the participants in the HPV vaccine trial, on two of the points that could be part of a National Ethical Code. First, the depth of subjects' knowledge about their informed consent could be tested. These measurements may help to prove that all stakeholders have the same idea of 'informed consent', so that prospective trial subjects and people with diseases will gladly volunteer to have their names and particulars recorded on registers. Second, these Phase III vaccine trial participants should have lower rates of STIs than women who are not in a trial, according to the Academy. They are in the hands of sexual health practitioners who apply best practice of STI education, instruction and prevention. Of course, people who use barrier protection are less likely to become infected with HPV, and that will prolong the vaccine trial, so there is a profound dilemma in this situation. How has GSK protected its’ shareholders interests against the risk of trial subjects becoming infected with Chlamydia, or any of the more troublesome STIs? Did the protocol for the HPV vaccine trial require that the subjects indemnify the manufacturer against claims for HIV infection, and for subsequent infertility, due to chlamydial infection? 1. The Academy of Medical Sciences. Use of patient data in medical research: Call for evidence. < http://www.acmedsci.ac.uk/p_patientdata_cfe.pdf > 2. The Academy of Medical Sciences. Report of an Academy working group: 'Strengthening Clinical Research'. Oct 2003. < http://www.acmedsci.ac.uk/p_scr.pdf > 3. Department of Health. Pharmaceutical regulation to be more open and transparent. Press Release, Nov 11, 2004. < http://tinyurl.com/4ofj8 > 4. GlaxoSmithKline Biologicals. A GSK cervical cancer vaccine shows promising efficacy data to be published in The Lancet. Press detail, Nov 12, 2004. < http://tinyurl.com/55wm6 > 5. Szarewski A, Sasieni P. Cervical screening in adolescents--at least do no harm. Lancet 2004;364:1642-4. < http://tinyurl.com/4wkyd > 6. Department of Health. Choosing health: making healthy choices easier - Executive Summary. Nov 18, 2004. < http://tinyurl.com/3ttbu > Competing interests: None declared
Aripiprazole advertisement 26 November 2004
Clive E Adams, Chair of Adult Psychiatry, Co-ordinating Editor, Cochrane Schizophrenia Group Academic Unit of Psychiatry and Behavioural Sciences, University of Leeds, 15 Hyde Terrace, Leeds , Send response to journal: Re: Aripiprazole advertisement	The hard copy of the BMJ (19th November 2004) in the UK opened (left to right) with a double page colourful advertisement for aripiprazole for people with schizophrenia. A large 'A' straddles the road to a sunlit horizon. In two studies used to justify the use of this drug eight people died (total n=834, average age 52 years, 5 weeks duration)(1,2,4). These data do not appear in the journal reports(3). The deaths are not reported by group of allocation so it is impossible to tell whether they were more likely to occur in the aripiprazole or the haloperidol or placebo control. Even if the mortality of people with schizophrenia is two to three times that of the general population(5) - the death rate in these two studies exceeds even that pessimistic estimate by 400-500%. It is difficult for good evidence (4) to compete with well designed advertising. Reference list 1. Adson D, Bari B, Bona J, Garner DL, Hafez H, Janicak PG et al. Abilify (aripiprazole) tablets, medical review, part 1. In. Dubitsky GM, Harris R, Laughren T, Hardeman S www.fda.gov/cder/foi/nda/2002/21- 436_Abilify.htm 2002;1-50. 2. Carson WH, Pigott TA, Saha AR, Ali MW, McQuade RD, Torbeyns AF et al. Aripiprazole vs. placebo in the treatment of chronic schizophrenia. International Journal of Neuropsychopharmacology 2002;Suppl 1:187. 3. Dubitsky GM, Harris R, Laren T, Hardeman S. Abilify (aripiprazole) tablets, medical review. http://www.fda.gov/cder/foi/nda/2002/21- 436_Abilify_medr_P4.pdf 2002;[Page 198, Adson et al = 97201, Carson 2000 et al =138001, date accessed 22/11/04]. 4. El-Sayeh HG, Morganti C. Aripiprazole for schizophrenia. Cochrane Database Syst Rev 2004 Issue 3. 5. Office for National Statistics. Census 2001. Age Standardised Mortality Rates by Sex and Cause. www.statistics.gov.uk/StatBase/Expodata/Spreadsheets/D7739.xls 2001. Competing interests: None declared