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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: David Oliver: What GPs told me about how they see the future David Oliver. 358:doi 10.1136/bmj.j3976

I thank Dr Begg for his response

In my 500 word column i did no more than signpost and distil what a whole range of GPs had told me in response to my soliciting their views. That is not "coming to reductionist conclusions" it's merely taking a conversational wander through the responses i received, not an attempt to produce a systematic review.

With regard to GPs being as diverse in range of roles and skills as hospital doctor, i could not have been clearer in my column that this was the case and GPs and Practices, settings and populations as heterogenous.

With regard to the House of Lords Committee on NHS sustainability i very explicitly referenced this in my column and was equally clear that many GPs felt that the kind of conclusions it came too were politically motivated and not endorsed by GPs themselves. And i am well aware that the committee was heavily crtiicised for taking little evidence from GPs whilst at the same time coming to what appeared to be a predetermined condemnation of General Practice

If he has the time and inclination, i would commend Dr Begg to read the range of eloquent and persuasive rapid responses all written by GPs themselves which i tried to distil in writing this column.

David Oliver

Competing interests: No competing interests

16 September 2017
David Oliver
Physician
NHS
Re: Estimates of burden and consequences of infants born small for gestational age in low and middle income countries with INTERGROWTH-21st standard: analysis of CHERG datasets Hannah Blencowe, Mariangela F Silveira, Ayesha Sania, Heather E Rosen, et al. 358:doi 10.1136/bmj.j3677

Huge disparity in SGA detection rates

We compliment the researchers for their effort and analysis of this massive CHERG datasets. We would like to comment from our experience about the reported small for gestational age (SGA) rates for India of 36%, and the 2012 neonatal mortality rates of 30/1000 live births.

Neonatal mortality in SGA is dependent on multiple factors, most important being antenatal identification, intrapartum monitoring and neonatal care available. Many public institutionsin India may not have resources for recommended fetal growth assessment, intrapartum monitoring facilities and availability of professional neonatal team to take care after birth. Stillbirths in SGA is a direct end point and a better marker to assess the performance of a centile chart. Over diagnosis of SGA may lead to over interventions which is currently a worrying problem for India. Both customised centiles and our hospital centiles for the newborn give an SGA incidence of 10.3% for our institute with a stillbirth rate of 6/1000 and neonatal mortality rate of 4.6/1000 for the year 2016 (for more than 28 weeks, total of 8642 births).

Gestational age assessment was correlated by ultrasound in six out of 14 data cohorts only. Clinical methods and neonatal examination based gestational age assignment are not known to be very reliable. It would have been more interesting if this analysis was limited to those with ultrasound confirmed gestational age. Low birth weight definition of less than 2500 gm is dependent on the gestational age and not a good marker for fetal growth restriction in comparision to SGA.

The SGA rates of China has been mentioned as 4.6% which may be an underdiagnosis for that population. The scope of prevention of neonatal deaths definitely exists in low / middle income countries, and has to be targetted at SGA detection, management with an appropriately timed delivery and good neonatal care facilities. The extent of decrease would depend on the scale used to differentiate normality from abnormality. Any scale which demarkates 36% of the population as abnormal has to have a rethink.

Competing interests: No competing interests

16 September 2017
NUZHAT AZIZ
Consultant obstetrician
Re: Margaret McCartney: Nuclear weapons do harm, even if never used Margaret McCartney. 358:doi 10.1136/bmj.j3978

Most weeks Margaret McCartney cites the importance of evidence in her campaigns to avoid change by such iniquities as medical innovation. What a surprise to see her ditch her normal evidential discipline to promote faith in her political preconceptions.
Historical evidence shows that no nations with nuclear weapons have engaged in war (the practice of putting young men at risk to support the aspirations of older politicians) since Nagasaki. Are her opinions, formed as a medical student in the late 1980's, based on evidence or opinion? By the time she indulged her own freedom of speech I had served in hospital ships in a non-nuclear war in the South Atlantic and cared for "soldiers" including Argentinian schoolboys for the benefit of the freedom of Falkland Islanders. At the time I rationalised (and I still do) that it is worthwhile to die for the freedom of one's fellow man: I volunteered to put myself into the face of danger eight thousand miles from home. Later I served in Submarines for three months at a time and thought long and hard about the ethics of nuclear deterrence: historical evidence convinced me of the benefit of deterrence.
When she next cycles along Loch Long, perhaps Dr McCartney might consider the evidence that shows beyond reasonable doubt that, in the conventional warfare she apparently prefers, it is young men who die and are maimed while in nuclear exchanges, the politicians would also pay the price (hence no weapon has been used). Brave young American, British And Russian men serve in the depths of the oceans to ensure that she can peddle her myths of monolateral joint and cataract treatment.
Banning nuclear weapons from those who dare not use them would simply permit rogue states like North Korea to cause mayhem. Is it not irresponsible to to take any other view or should we also support the "freedom fighters" who leave bombs on tube trains and buses to maim our patients indiscriminately?
To consider nuclear weapons as "never used" is to misrepresent the philosophy of deterrence so eloquently described as Mutual Assured Destruction (MAD) by Robert McNamara whose grave lies largely unnoticed in Arlington Cemetery about 100 yards from that of JFK. Every moment a deterrent (of East of West) is deployed and not fired it is being used to keep the peace in preventing bullets from disrupting the chests of soldiers and front-line civilians who are human beings, just like Dr McCartney and her patients.
Isn't it time the Editor of the BMJ started editing her journal? She might start by seeking evidence from Dr McCartney on monolaterality of joint replacement and cataract treatment in Scotland which is not the experience of my (Scottish) patients. If the evidence is not produced, perhaps Dr McCartney's contract might be reviewed on the basis that my former military constituents are BMA members and therefore shareholders of the company that pays the Editor's wages and whose contributions are belittled by uninformed political posturing.
If this rapid response is published, Dr McCartney should immediately cite the evidence (not simply her report) that pensioners are told "there's only enough money to take out one cataract"; otherwise the Editor should fulfil her duty to BMA members to ensure that the BMJ is "Evidence Based".

Competing interests: I am a former Armed Forces Doctors Representative on BMA Council. I have served in conventional conflict and in the Cold War. I have been a member of the BMA Armed Forces Committee

15 September 2017
Andrew J Ashworth
GP
Re: David Oliver: What GPs told me about how they see the future David Oliver. 358:doi 10.1136/bmj.j3976

Dear David
Thank you for trying to explore how GPs see the future. Something those of us who seek to represent GPs grapple with regularly.
Your question is as useful as asking 'how do hospital doctors see their future'. Not useless but of limited use. A geriatrician and an intensive care doctor may have differing views but they will be valid in the context that they work.. Those providing primary care to different populations need their specific views heard and heeded. Reductionist analysis leads to a number of erroneous over-simplistic conclusions in your piece. You are in good company though - a House of Lords committee managed this too!!
On a positive note you got one thing right - 'a one size fits all model' is pointless. As pointless as it would be to put all surgeons/physicians/anaesthetists/obstetricians/paediatricians/etc in the same basket simply because they typically work in a hospital.

Competing interests: No competing interests

15 September 2017
A. Drummond Begg
gp
NONE
Re: Risk of relapse after antidepressant discontinuation in anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder: systematic review and meta-analysis of relapse prevention trials Klaas M Huijbregts, Anton J L M van Balkom, et al. 358:doi 10.1136/bmj.j3927

I would like to thank the authors for trying to help clinicians who are responsible for long term prescribing of drugs. Whenever a drug is prescribed both patient and doctor should ask the question what are the long term benefits and harms. Deprescribing is as important as prescribing to reduce the risks of unnecessary polypharmacy.
Unfortunately the meta-analysis doesn't appear to analyse long term all cause harms. People (formerly known as patients) would rather have a single n1000 trial looking at all cause harm vs benefit over a much longer period. Trial should not be performed by a drug company with a vested interest in outcomes. We then need better data on the long term benefits and all cause harms of non-drug treatments to provide people with more meaningful choices. Better primary research rather than more meta-analysis please.

Competing interests: No competing interests

15 September 2017
A. Drummond Begg
GP
NONE
Re: No overall increase in all cause mortality with HRT, study finds Jacqui Wise. 358:doi 10.1136/bmj.j4230

Epidemiological studies can seriously mislead if epidemiologists do not have clean never users of hormones for controls. Their resulting data can encourage false claims of benefit or no effect .1

How many deaths would there been if the Women's Health Initiative Studies, of either combined progestogen HRT or estrogen only HRT, had not been terminated prematurely? This was because of unacceptable increases in cancers and vascular diseases? Most women enrolled had previously used progestogens and oestrogens for either contraception or therapy but nevertheless, the WHI epidemiologists randomly divided the women into Takers or Never takers.

In reality, the world-wide fall in hormone use after the early WHI terminations resulted in decreases in breast and ovarian cancer incidence and mortality. 2-5

Use of HRT progestogens and oestrogens quickly increases the main causes of death. It is a shame to encourage use of carcinogenic, vasoactive, psychoactive and immune modulating hormones merely to suppress vasomotor symptoms. As a clinician, I have found avoiding smoking and alcohol, low allergy high protein diets, repletion of essential nutrients to be safe and basic .6,7 There are more details in my lectures at www.harmfromhormones.co.uk

1 No overall increase in all cause mortality with HRT, study finds. BMJ 2017;358:j4230

2 Grant ECG. Reduction in mortality from breast cancer: fall in use of hormones could have reduced breast cancer mortality. BMJ. 2005 Apr 30;330(7498):1024.

3 Colditz GA. Decline in breast cancer incidence due to removal of promoter: combination estrogen plus progestin. Breast Cancer Res. 2007;9:108.

4 Ravdin M, Cronin KA, Howlander N, Berg CD, Chlebowski RT, Feuer EJ, Edwards BK, Berry DA. The Decrease in Breast Cancer Incidence in 2003 in the United States.NEJM. Vol. 356, No.16. April 19, 2007

5 Grant Ellen C G. Endometrial cancer with progestagen and oestrogen oral contraceptives. The Lancet Oncology, 2015;16: 15,e527

6 Grant ECG. Food allergies and migraine. Lancet 1979;1:966-6.

7 Grant ECG. The pill, hormone replacement therapy, vascular and mood over-reactivity , and mineral imbalance .J Nutr Environ Med 1998;8:105-116.

Competing interests: No competing interests

15 September 2017
Ellen C Grant
Physician and medical gynaecologist
Retired
Kingston-upon-Thames, UK
Re: Substance misuse in older people Rahul Rao, Ann Roche. 358:doi 10.1136/bmj.j3885

Substance misuse is not simply a risk to the health of older people but a risk factor for elder abuse and neglect. The older person who may be unable to care for him/herself and reliant on others may become increasingly neglectful of their person, their relationships and surroundings, becoming 'easy prey' to those who take advantage of them. But so too can other people's substance misuse negatively affect older people - whether they are family members, care home residents or neighbours. In community and long-term care settings the misuse of substances by a minority of people 'caring' for older people has been shown to impact on their care and treatment, and ultimately on their wellbeing. For care services, the role of taking up references and checking on staff provides some valued monitoring. Health professionals can act as the 'eyes and ears' of safeguarding when meeting with older people who may be at risk of harm from their own or others' substance misuse.

Competing interests: No competing interests

15 September 2017
Jill T Manthorpe
Professor of Social Work
London
Re: Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study Sana R Mostaghim, Joshua J Gagne, Aaron S Kesselheim. 358:doi 10.1136/bmj.j3837

It is good to read the research article “Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study”.

Expedited approvals for new drugs include, “Accelerated approval pathway”, “Breakthrough therapy”, “Fast track designation”, and “Priority review”. The Food and Drug Administration (FDA) initiated “Accelerated approval regulations” in 1992, and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 2012 allowed the FDA "Accelerated approval for the drugs for serious conditions" with an unmet medical need, based on a surrogate marker or an intermediate clinical endpoint; it also included “Breakthrough therapy”[1,2]. FDA designed a “Fast track process” to facilitate the development, & a “priority review” for faster review within six months (compared to 10 months under standard review) [3,4].

Drug companies must conduct a “confirmatory trial” once the drug is on the market in an accelerated approval program and the FDA must take appropriate action regarding its approval if the drug’s safety or efficacy results are questionable [5].

Post-approval studies seldom cover the "deficit of knowledge" (orphan drugs) [6]. FDA in their letters generally do not approve applications for new drugs for reasons related to safety and efficacy deficiencies [7]. Fast-track drugs approval by the FDA is harmful and not good for the public at large, the reason being that drug companies are paying huge sums to fast-track FDA approval [8].

Evidence based medicine appears to be broken owing to corruption in clinical research and also to overdiagnosis harming the patients & healthy people [9,10].

Big pharma companies seem to increase the costs of drugs owing to commercial & professional vested interests and health system incentives favouring more tests and treatments [11].

It is not just the responsibility of regulatory bodies at a high level: responsibility starts with "Investgators who are involved in the study" and “Institutional Ethics Committees” /or “Institutional Review Boards”, which have a major role in approving the projects/RCTs. Responsibility also lies with "Sponsors/ Funders" of the projects/RCTs.

The FDA should take appropriate measures to prevent the misuse of "Expedited regulatory pathways" for the safety of patients at large. Thank you for an interesting and a relevant research article.

Regards,

References:
1. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm
2. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm
3. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
4. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm
5. BMJ 2015;351:h5260
6. http://www.bmj.com/content/353/bmj.i2978
7. http://www.bmj.com/content/350/bmj.h2758
8. http://fortune.com/2015/10/20/pharma-fda-vouchers-resale/
9. http://www.bmj.com/content/348/bmj.g22
10. http://www.bmj.com/content/344/bmj.e3502
11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4046551/

Competing interests: No competing interests

15 September 2017
Dr. Rajiv Kumar
Faculty
Dr. Sangeeta Bhanwra, Dr. Jagjit Singh, Faculty, Dept. of Pharmacology, Government Medical College & Hospital, Chandigarh, India.
Dept. of Pharmacology, Government Medical College & Hospital Chandigarh 160030. India.
Chandigarh, India
Re: Autopsy results confirm 4 year old Italian girl died from malaria Michael Day. 358:doi 10.1136/bmj.j4235

Malaria is re-established in many Regions in neighboring Greece. [1][2]
If this Italian girl had previously been for summer vacations in Greece she could have been infected there.
References
[1] http://www.bmj.com/content/344/bmj.e2935/rr
[2] http://www.bmj.com/content/344/bmj.e2935/rr/603727

Competing interests: No competing interests

15 September 2017
Stavros Saripanidis
Consultant in Obstetrics and Gynecology
Re: Should Google offer an online screening test for depression? Ken Duckworth, Simon Gilbody. 358:doi 10.1136/bmj.j4144

If online screening with the PHQ-9 test detects depressive traits, patients should be reminded that CBT or Behavioural Activation effectively treat clinical depression.
A meta-analysis published in the British Journal of Psychiatry has found that even patients with the most severe depression can expect to get as much benefit from cognitive behavioural therapy (CBT) as those with less severe symptoms. [1]
Even junior MHWs, trained for only 5 days, were able to deliver Behavioural Activation sessions against Depression, with equally effective outcomes, compared to CBT or second generation antidepressant pharmacotherapies, without side effects. [2][3]
Google (Alphabet Inc) could subsequently offer free peer-reviewed online computerized CBT AI sessions.
References
[1] http://bjp.rcpsych.org/content/210/3/190.long
[2] http://www.bmj.com/content/356/bmj.j914
[3] http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31140-0/fulltext

Competing interests: No competing interests

15 September 2017
Stavros Saripanidis
Consultant in Obstetrics and Gynecology

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