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Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on thebmj.com. Although a selection of rapid responses will be included online and in print as readers' letters, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window. Letters are indexed in PubMed.

Re: Risk of major congenital malformations in relation to maternal overweight and obesity severity: cohort study of 1.2 million singletons Björn Pasternak, Olof Stephansson, Martin Neovius, et al. 357:doi 10.1136/bmj.j2563

Obesity has reached epidemic proportions globally, with at least 2.8 million people dying each year as a result of being overweight or obese (WHO, 2017). This reality has now been accepted worldwide. Also accepted is the fact that obesity comes with much co morbidity (Jarolimova, Tagoni, & Stern, 2013; Pệrez, Sệnchez, & Ortiz, 2013). However, this cohort study on the risks of major congenital malformations in the offspring of mothers has now shown that there is another trajectory: Overweight or obese mothers’ newborns are at high risk of being incapacitated. What is interesting to note is the solution suggested “efforts should be made to encourage women of reproductive age to adopt a healthy lifestyle and to obtain a normal body weight before conception”. Although the detail of how this should be done was not mentioned, in essence this is basically saying to women, reduce weight prior to pregnancy because you may end up with deform babies. This of course should be taken seriously, as ignoring it can possible lead to serious financial, social and psychological burden for any individual or country. What is obvious though is that, if this is the only approach, we need to be gravely concern because over the years individuals almost in every household across the globe have seen the impact and effects of obesity on themselves, families, and countries yet “about half a million people in North America and Western Europe die from obesity-related diseases every year” (WHO, 2002). Knowledge alone has not made an impact. A multifaceted approach is needed.

Therefore, knowing of, or even seeing, defective babies of overweight moms may not be a strong enough motivating factor for women of childbearing age to want to reduce their weight. In addressing this issue males and females should be targeted. Humans basically operate within an interactive environment. The male partner is a strong influential force and should not be left out of taking responsibility for the health of his potential unborn child. His lifestyle could well be supporting his spouse weight gain.

A more effective approach in addressing the crisis of obesity is to begin the process of engraving upon the minds of the youth (boys and girls) the responsibilities they have to themselves and to their, families, countries, nations and the world in making healthy lifestyle choices. It must be a part of their curriculum. It must commence in the schools and continue throughout varying academic levels. Additionally, both the private and public sectors must address the workplace and school infrastructures to support a healthy lifestyle so that knowledge and practice are integrated. The World Health Organization, 2017 has stated “Governments, international partners, civil society, non-governmental organizations and the private sector all have vital roles to play in contributing to obesity prevention” To begin this journey these bodies must focus their interventions at the school levels. That is where policy makers must have their impact and recommendations must be made.

References
Jarolimova, J., Tagoni, J., & Stern, T. (2013).Obesity: Its epidemiology, comorbidities, and management. Retrieved June 19, 2017, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3907314/

Pệrez, C., Sệnchez, H., & Ortiz, A. (2013).Prevalence of overweight and obesity and their cardiometabolic comorbidities in Hispanic adults living in Puerto Rico. . Retrieved June 20, 2017, from https://www.ncbi.nlm.nih.gov/pubmed/23846388

World Health Organization (2017). 10 Facts on obesity. Retrieved June 19, 2017, from http://www.who.int/features/factfiles/obesity/en/ World Health Organization (2002). Enemies of health, allies of poverty. Retrieved June 19, 2017, from http://www.who.int/whr/2002/overview/en/index1.html

Competing interests: No competing interests

20 June 2017
Hilda M. Ming
Director -Nursing Staff Development
University Hospital of the West Indies, Jamaica
5 Ring Road, University Hospital of the West Indies Campus, Mona, St. Andrews. Jamaica
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Re: David Oliver: Towards a GP consensus on the future of UK general practice David Oliver. 357:doi 10.1136/bmj.j2949

I do wonder whether there is the breadth of diversity in competency, technical know how and other industry experience applied to future health workforce models. For example, has the NHS ever consulted with airlines, with tech firms, other service industries on how workforce models should be designed?

And before everyone sighs and says "ooh health is different"..

I don't doubt the gravitas of professional knowledge, but UK GPs and NHS professionals only know what they know.

Just how diverse is the workforce design process?

John

Competing interests: No competing interests

20 June 2017
John M Bennett
Partner
None
Tavistock
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Re: David Oliver: Towards a GP consensus on the future of UK general practice David Oliver. 357:doi 10.1136/bmj.j2949

There are some well articulated truths in this piece, which we will need to address as a profession if we are to preserve the qualities that have made British general practice so great.

The fact is, we are a broad church, often with very divergent views on the solutions to our challenges. We continue to have difficulty making the case for increased resource, in spite of the universal rhetoric that more should come our way.

I have seen GP from all sides from senior partner and trainer, and in medical management at an integrated health board. The truth is, we will almost certainly require a mixture of models of care based on local need in order to keep us alive.

GP at its best is one of the most rewarding careers in the world but we are not at our best just now.

As David suggests, we should reflect on all of the reasons why this is so and seek to address them, because current tactics aren't working.

Competing interests: No competing interests

20 June 2017
Sally A Lewis
GP and Assistant Medical Director, Aneurin Bevan University Health Board
Crickhowell
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Re: Drugs with FDA accelerated approval often have weak evidence, study finds Owen Dyer. 357:doi 10.1136/bmj.j2905

Naci, from the London School of Economics, commenting on his analysis showing evidence that drugs with FDA accelerated approval often have weak evidence, claimed: “research practices on these drugs rarely meet the information needs of patients, doctors, and other decision makers in healthcare systems,”.(1,2)

First, this is not news.(3,4) Moreover post-marketing studies are performed in only two-thirds of cases and when performed it is with a median delay of 4 years.(4)

One can understand that stakeholders could rely on hope, too much, and that finding a prudent middle ground to protect patient interests represents an immense tension for drug regulators.

Nevertheless accelerated approval is associated with unreasonable delays in market withdrawal, even in the case of drug-related deaths.(5) For lack of efficacy, the process is even slower: drotrecogin alfa was not withdrawn for 10 years after initial approval and bevacizumab was approved for metastatic breast cancer in February 2008 under the FDA accelerated program and the license was not revoked until November 2011.

No one can understand how the system can have been so wrong for so long: FDA goes too fast for approval and too slow for withdrawal, the European Agency too.(6,7)

1 Dyer O. Drugs with FDA accelerated approval often have weak evidence, study finds. BMJ 2017;357:j2905.

2 Naci H, Wouters OJ, Gupta R, Ioannidis JPA. Timing and characteristics of cumulative evidence available on novel therapeutic agents receiving Food and Drug Administration accelerated approval. Milbank Q2017;357:261-90.

3 Kim C, Prasad V. Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and Drug Administration approvals. JAMA Intern Med 2015;175:1992-1994.

4 Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R. Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst 2011;103:636-644.

5 Braillon A, Menkes DB. Balancing accelerated approval for drugs with accelerated withdrawal. JAMA Intern Med 2016;176:566-7.

6 Davis C, Lexchin J, Jefferson T, Gøtzsche P, McKee M. "Adaptive pathways" to drug authorisation: adapting to industry? BMJ 2016;354:i4437.

7 Bolland MJ, Grey A. Ten years too long: strontium ranelate, cardiac events, and the European Medicines Agency. BMJ 2016;354:i5109.

Competing interests: No competing interests

20 June 2017
alain braillon
senior consultant
University Hospital. 80000 Amiens. France
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Re: Jeffrey Tate Penny Warren. 357:doi 10.1136/bmj.j2937

We thank Dr Martin F Heyworth for his rapid response alerting us to an error in the obituary of Jeffrey Tate. We apologise for the error, which was introduced during editing.

The penultimate sentence of the last paragraph under the heading "From inpatient to medic" should read:

"Having moved to St Thomas’ Hospital in London, he ran the music society and produced Purcell's Dido and Aeneas in Southwark Cathedral" [not Handel's Dido and Aeneas as published].

Competing interests: No competing interests

20 June 2017
Sharon Davies
letters editor
The BMJ, London WC1H 9JR
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Re: Public’s distrust of medicines needs urgent action, says academy Nigel Hawkes. 357:doi 10.1136/bmj.j2974

... It would be for the Editor of «La Revue Prescrire», one of the best journals of clinical pharmacology in the world, to comment on this News.

Year after year, Prescrire has had quite a hard time locating molecules which represented real advance among the multitude of overly priced me-too drugs..

This, and the fact that polypharmacy is reaching epidemic proportions, makes me wonder whether it is true that « public’s distrust of medicines needs urgent action».

Competing interests: No competing interests

20 June 2017
Piero Baglioni
Physician
Centre Hôpitalier Saint Jean d'Angely France
17400 Saint jean d'Y France
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Re: Immediate complete lymph node dissection does not improve melanoma survival, study finds Michael McCarthy. 357:doi 10.1136/bmj.j2830

Overzealous invasive intraoperative excission of axillary/regional lymph nodes must be reconsidered, since survival rates of patients with melanoma or breast cancer are not affected.
"Conservative surgery is more favourable on survival."
Even breast tumours larger than 2 cm demonstrated 96% survival rates, irrespective of the number of positive lymph nodes. [1]
Reference
[1] BMJ 2015;351:h4901
http://www.bmj.com/content/351/bmj.h4901

Competing interests: No competing interests

20 June 2017
Stavros Saripanidis
Consultant in Obstetrics and Gynaecology
Kalamaria, Thessaloniki, Greece
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Re: Public’s distrust of medicines needs urgent action, says academy Nigel Hawkes. 357:doi 10.1136/bmj.j2974

Public is correct in distrusting medicines, according to mainstream academic research data.
FDA approves and allows marketing drugs often based on weak evidence. [1]
"Indispensable flu medication" in eventually downgraded by WHO. [2]
Flawed research conclusions induced US opioid addiction crisis. [3]
Widely prescribed statins in older people are useless for primary prevention. [4]
Cheap chondroitin sulfate is as effective as the widely prescribed expensive non-steroidal anti-inflammatory drug (NSAID) celecoxib for treating painful knee osteoarthritis. [5]
Corticosteroid injections for painful knee osteoarthritis produce no benefit and might even be harmful to cartilage. [6]
Levothyroxine should no longer be prescribed in elderly patients with subclinical hypothyroidism. [7]
These referenced conclusions arose after reviewing clinical publications on the BMJ appeared online only during the last 2 months.
Who can accuse patients of being skeptical about commonly prescribed pharmaceuticals, after this?
References
[1] http://www.bmj.com/content/357/bmj.j2905
[2] http://www.bmj.com/content/357/bmj.j2841
[3] http://www.bmj.com/content/357/bmj.j2741
[4] http://www.bmj.com/content/357/bmj.j2486
[5] http://www.bmj.com/content/357/bmj.j2515
[6] http://www.bmj.com/content/357/bmj.j2386
[7] http://www.bmj.com/content/357/bmj.j1754

Competing interests: No competing interests

20 June 2017
Stavros Saripanidis
Consultant in Obstetrics and Gynecology
Kalamaria, Thessaloniki, Greece
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Re: Do doctors have a duty to take part in pragmatic randomised trials? Marion K Campbell, Charles Weijer, Cory E Goldstein, Sarah J L Edwards. 357:doi 10.1136/bmj.j2817

Charles Weijer and his colleagues are correct to assert that people should be able to choose how they help others when there is uncertainty about the effects of treatments (1); but a flawed ethical analysis prompts them to take too narrow a view of how this should be done. I offer here some principles for guiding choices in publicly-funded health services, noting that principles may differ in health services that reject shared risk, shared benefit, and shared cost.

When there are uncertainties about the effects of alternative treatments already in use, patients should be made aware of these uncertainties and declare any preferences they have for (i) choosing any of the existing treatment alternatives; or (ii) choosing to participate in randomized trials to reduce uncertainties about their relative merits.

If the uncertainties relate to the relative merits of new treatments compared with treatments already in use, patients should be offered the choice of existing treatments, or the choice to participate in randomized trials comparing the inadequately evaluated new treatments, so helping to generate the evidence needed to assess whether the new treatment is more likely than existing treatments to do good than harm, at acceptable cost.

None of the above options exposes patients to “risks primarily for the benefit of other people”, as suggested by Weijer et al. Indeed, for the high proportion of patients with chronic health conditions, reducing uncertainties can be expected to improve the evidence base for their future health choices (2).

The continued promotion of flawed and narrow ethical analyses has resulted in the avoidable suffering of millions of people, the vast majority of whom have not been the participants in research to whom Weijer and colleagues have inappropriately restricted their attention (3).

References
1. Weijer C, Goldstein CE, Edwards SJL. Do doctors have a duty to take part in pragmatic randomised trials?: No. BMJ 2017;37:j2817.
2. Chalmers I. What do I want from health research and researchers when I am a patient? BMJ 1995;310:1315-1318.
3. Chalmers I. Regulation of therapeutic research is compromising the interests of patients. International Journal of Pharmaceutical Medicine 2007;21:395-404.

Competing interests: No competing interests

20 June 2017
Iain Chalmers
Coordinator
James Lind Initiative
Summertown Pavilion, Middle Way, Oxford OX2 7LG
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Re: Margaret McCartney: Remember that doctors are more trusted than journalists Margaret McCartney. 357:doi 10.1136/bmj.j2608

Re Margaret McCartney's piece on what to do in response to the Daily Mail's incessant doctor bashing, the answer is, nothing. If there is one thing that we have learned from the recent general election it is that the influence of the Daily Mail on political discourse is waning. We should rejoice in this fact and learn to ignore their more outlandish positions on matters pertaining to health care. Jeremy Corbyn refused to take their bait in his election campaign, and it seems to have done him no harm.

Competing interests: No competing interests

20 June 2017
Robert Bennett
General Practitioner
Oxford
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