Correspondence with the National Institute for Health and Clinical Excellence

This page lists correspondence with the National Institute for Health and Clinical Excellence. On 3 December 2012 BMJ editor in chief Dr Fiona Godlee wrote to NICE's chair, Professor Sir Michael Rawlins. In her letter she says: "Now that serious doubts have been raised about the evidence behind claims for oseltamivir’s effectiveness and safety, I am asking you to withdraw approval for oseltamivir until NICE has received and reviewed the full clinical trial data and those anonymised data are available for independent scrutiny."

 

All rapid responses

Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on bmj.com. Although a selection of rapid responses will be included as edited readers' letters in the weekly print issue of the BMJ, 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.

Dear Editor,


Ebola virus disease (EVD) has in a way been spreading scare around the globe. Now with this news of the WHO placing 15 countries at countries at risk, maybe it will help these countries to brace themselves up, god forbid, for possible fresh cases of EVD, and a resultant flare up in the number of cases. This outbreak has already killed nearly 4500 people. But the best news is that some patients are getting saved, and that Nigeria and Senegal have been declared Ebola-free by the WHO.


We believe that whatever best can be done, is already being done by the world and the nations afflicted by EVD. Maybe if the policy makers, administrators, and scientists concentrate for a while on another aspect as well, in addition to all that is being done, maybe it might help contain the spread of this virus. We don’t have any proof or evidence to prove what we are opining out here, but we do believe that insects, arthropods, bugs and beetles, mites, etc, and any other animals that might be digging into a grave to consume the remains of the dead, should also come up on the watch.


Maybe there is a need for the body-bags and burial containers to be given that extra protection so that they can remain safe, undisturbed, by insects as well as other animals that might dig out the body. Cemeteries should otherwise be placed out of bounds, once a burial is over. Until proved otherwise, we need to be wary of insects in and around a grave, and for all animals known for digging out the dead and using it in its food chain.


Fruit bats consumption, as also the consumption of sick or animals that are found dead in the bush or in game parks must be stopped. Such carcasses must be burnt and disposed off swiftly, while taking all the necessary precautions. Spitting, vomiting, coughing, urinating or defecating in the open should be stopped. Simple things like hand washing, avoidance of eating raw and uncooked food, climbing trees to catch fruit bats and thus avoiding the fruit bats as also the insects that might be on the tree and may come to bite or get lodged in the body, must be avoided.


Finally, before going to attend a burial ceremony, it may be prudent to smear your body with an insect repellant like eg the DMP oil (Dimethyl phthalate) that is cheap and quite effective as well for repelling insects. We are uploading three figures and a write up, that might help understand our points in a better manner. Although we are not sure that these points given by us will be helpful completely, but this is our small contribution to the efforts that are already in place by the world.


Best regards.

Competing interests: The views expressed are those of the authors, and do not reflect any official policy or position of any organization or association. Much of all this is part of our book that we are presently writing on Ebola.

21 October 2014
Dr (Lt Col) Rajesh Chauhan
Consultant Family Medicine
Dr. Shruti Chauhan; Dr. Ajay Kumar Singh Parihar; Shivendra Pratap Singh Chauhan
Honorary National Professor IMA CGP, India
154 Sector 6 - B (HIG), Avas Vikas Colony, Sikandra, AGRA -282007. INDIA.
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I agree with David Paintin that young teenagers can become pregnant due to sexual abuse from older men and an induced abortion is needed.1 However, must progestogen steroid abuse be added to sexual abuse? Any study of induced abortion with either breast cancer or depression is confounded by age of first use of progestogen-based hormonal contraceptives.

There is no doubt that breast cancer risks increase with longer use of oral contraceptives (OCs). Longer use relates to age of first pregnancy and first hormone use. The data from the UK National Case-control Study of breast cancer before age 36.2 Of women with young age breast cancer cases 80% had used OCs for more than 4 years if they started use before age 19 while only 30% of cases were longer users if they started after age 24. Figure1 In the USA breast cancer with distant metastatic involvement has increased by 78% in women aged 25 to 39 and their 5 year survival rate was 31%.3 Increases in breast cancer have matched increases in hormone use since 1962. Figure 2

Progesterone or progestins can cause depression by increasing monoamine oxidase levels in the late secretory phase of a normal cycle or during medication with a progestin.4 Monoamine oxidase inhibitor drugs are antidepressants.

A levonorgestrel containing Intra Uterine System is classified as a “newer” hormonal contraceptive but levonorgestrel is the active half of norgestrel. The highest doses of norgestrel tested in the 1960s caused depression and loss of libido when given with 50 micrograms of ethinyl oestradiol and also raised monoamine oxidase levels for most of the treated cycles.

In a Swedish study of nearly a million women progestin-only takers had significant increased risks of antidepressant use with most risk for 16-19 year olds including for those using combined hormonal contraceptives.5

High dose long acting progestogen contraception encourages longer use, more risk of breast cancer and depression due to suppression of warning symptoms.

1 Paintin DB. Re Management of teenage pregnancy. BMJ 19 October 2014 http://www.bmj.com/content/349/bmj.g5887/rapid-responses

2 UK National case-control study. Oral contraceptive use and breast cancer risk in young women. Lancet 1989;i:973-82.

3 Johnson RH, Chien FL Bleyer A. Incidence of Breast Cancer With Distant Involvement Among Women in the United States, 1976 to 2009. JAMA 2013;309(8):800-805.

4 Grant ECG, Pryce Davies J. Effect of oral contraceptives on depressive mood changes and on endometrial monoamine oxidase and phosphatases. BMJ 1968;3:777-80.

5 Lindberg M, Foldemo A, Josefsson A, Wirehn AB. Differences in prescription rates and odds ratios of antidepressant drugs in relation to individual hormonal contraceptives: a nationwide population-based study with age-specific analyses. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception. 2012;17(2):106-18.

Competing interests: No competing interests

21 October 2014
Ellen CG Grant
Physician and medical gynaecologist
Retired
Kingston-upon-Thames, KT2 7JU, UK
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In ‘The management of teenage pregnancy’ I read much good advice to fight this problem. Teenage pregnancy, together with the abortion rate, is an indicator of the state of civilization in a population.

Accessibility to contraception as well as availability of contraceptives and last but not least acceptability of contraception are the three pivotal factors that may limit teenage pregnancy and abortion rate. How can we explain the difference in teenage pregnancy and abortion rate between the UK and the Netherlands, while accessibility to and availability of contraceptives in both countries are well organized and high standard? Can we identify a difference in the third factor, acceptability of contraception, between the two countries? Acceptability of contraceptives and our attitude towards sex are associated. Some years ago, I, as a Dutch gynaecologist, was requested by the English teacher of our son to discuss the subject ‘genetics’ in his international class with students of 9 years old. After consultation with the teacher, she admitted that the essence of the lesson was sex education.

Competing interests: No competing interests

21 October 2014
Frans M. Helmerhorst
gynaecologist
Leiden University Medical Center
Albinusdreef 1, Leiden, the Netherlands
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I don't think that the pharma industry would bias studies evaluating the effect of their products on LDL cholesterol.

Such studies can be easily checked with short term inexpensive studies.

All competitors will compare the products, trying to show that their own is the best.

The effect of the product is known in early phase II studies and the result is important for the dose ranging of phase III studies.

The impact of the products on the biological endpoint occurs early and there are data from studies with no attrition. These studies without attrition are harder to bias.

To conclude: these results do not contradict the industry sponsorship bias because the pharma industry is not that stupid.

Main sources of bias are probably attrition and the survival analysis allowing patients to drop out. An example here: http://www.ncbi.nlm.nih.gov/pubmed/23662092

Competing interests: No competing interests

21 October 2014
Alexis Clapin
Neurologist
Paris
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Your nose accumulates mucus, dust, bacteria, viruses, and fungi. So your nose is an ideal environment for germs and sickness. It's important to clean your nose daily. The only effective way to clean your nose is nasal irrigation. Here's the technique: Buy a package of 3-ounce disposable cups (not a neti pot, because it breeds germs) and a salt shaker with a snap lid. Put two or three small shakes of salt in the cup, fill the cup with warm water, and stir with your finger. Too much or too little salt in the water will burn your nose. Bend over the bathroom sink, put your nose in the cup, and sniff. Don't be afraid of drowning. If the water gets in your mouth, you can just spit it out. Then blow your nose forcefully several times. Make sure you get all the water out of your nose. You'll be amazed at what comes out of your nose, and at how much better you feel.

Competing interests: No competing interests

21 October 2014
Hugh Mann
Physician
Retired
New York, USA
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The IOTA-ADNEX model [1] can be a very useful tool to help general gynaecologists in the management of women with adnexal mass and will eventually contribute to improve the outcomes of ovarian malignancies. Although the model is well designed and validated, the parameter “Oncology centre (referral centre for gyn-oncol)?” lacks clinical meaning. The authors stated, “We included the variable ‘type of centre’ because the risk of a malignant tumor is likely to be higher in oncology centres than in other centres, even after adjustments for the characteristics of patients and tumors”. The affirmation is statistically correct; the prevalence and distribution of malignant tumors were different comparing oncology centres with other hospitals. However, the reasons behind the differences were not explored.

Clinical data have long been used by general gynaecologists to classify adnexal mass as suspicious of malignancy and to refer patients to oncological centres for diagnostic and treatment [2]. Depending on the extent of clinical data available, it would be very interesting to know if “Oncology centre” is a surrogate for clinical signs of malignancy. Complete symptom index [3] requires prospective data collection, however, even if complete clinical data is not available, a simple parameter like mode of detection (image method or symptoms) [4] would sound more meaningful for generalist users.

1. Van Calster B, Van Hoorde K, Valentin L, et al. Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study. BMJ 2014;349:g5920 doi: 10.1136/bmj.g5920[published Online First: Epub Date]|.
2. The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer. Gynecol Oncol 2002;87(3):237-9
3. Goff BA, Mandel LS, Drescher CW, et al. Development of an ovarian cancer symptom index: possibilities for earlier detection. Cancer 2007;109(2):221-7 doi: 10.1002/cncr.22371[published Online First: Epub Date]|.
4. Wishart GC, Azzato EM, Greenberg DC, et al. PREDICT: a new UK prognostic model that predicts survival following surgery for invasive breast cancer. Breast Cancer Res 2010;12(1):R1 doi: bcr2464 [pii] 10.1186/bcr2464[published Online First: Epub Date]|.

Competing interests: No competing interests

20 October 2014
Francisco J. Candido-dos-Reis
Associate Professor of Gynecologic Oncology
Ribeirao Preto Medical School - University of Sao Paulo
Avenida Bandeeirantes 3900, 8o andar, Ribeirao Preto, Brazil. 14049-900
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Whether one chooses to walk blindfolded across a motorway at rush hour, invest in a financial scheme that seems too good to be true, or have unprotected sexual intercourse with a complete stranger, one might sensibly predict that engaging in such actions has the potential to lead to problems.

But human beings have an enormous capacity to deny the existence of the inevitable, let alone the probable or possible. Yet bad things can, and will, happen.

It has been abundantly clear for eons to anyone that cared to stand back and think for a moment that not just new epidemics of infectious diseases, but also other similar existential challenges to humanity, will inevitably come along. Ebola Virus Disease (EVD) is simply the latest such challenge, and it will most certainly not be the last.

Indeed, the emergence of EVD as a “cross-border security issue” reminds us that there exist major intersections between health and international relations, and provides some evidence that we may have been guilty all around the world of not planning appropriately for, and investing adequately in, dealing with something that was, in one form or another, inevitably going to come along one day.

Engaging seriously with “horizon scanning” for potential problems is therefore vital, and while humanity is now at last planning for and investing in dealing with EVD – however adequately or inadequately – we must not lose sight of the fact that other serious challenges will be coming along presently.

Wherever possible, whatever new we put in place – both in individual countries and worldwide - for dealing with EVD, it should surely be designed in such a way as to be able to help us maximally with dealing with those challenges that are yet to come.

For example, the emergence of XDRTB, MRSA, drug resistant HIV, and MERS has already shown us that there is a ghastly life beyond treatable TB, treatable Staphylococcus aureus, treatable HIV and SARS. Does anyone really believe that such developments represent the end of the story? Just what is coming next?

Equally, we in the early 21st century live under the shadow of a “deadly tide” of terrorism activity (http://www.un.org/en/globalissues/terrorism/), and a number of years ago the serious potential for pandemics arising out of bioterrorism was clearly pointed out (http://news.stanford.edu/news/2001/january17/bioterror-117.html). Importantly, at least some of this variety of human-initiated trouble might be preventable.

Greek mythology tells us of Cassandra, who was initially granted the gift of accurately seeing the future but was then cursed so that no one would ever believe her. We must avoid falling into such a “Cassandra Conundrum”, and somehow find the individual and collective professional and political will, imagination and energy to scan the horizons and take seriously and respond to what we observe.

EVD simply must be dealt with, but we should not then turn it into an excuse that lets us all off the hook with respect to other existential challenges. There is a clear need to consider and develop in advance the means to be able to face up to them. Furthermore, the absolute necessity to engage in effective planning is not something to be left to healthcare services but is also a matter for the wider political community, which must not only look inwards towards the state itself for remedies but also into the arena of international relations.

Competing interests: No competing interests

20 October 2014
Stephen T Green
Consultant Physician in Infectious Diseases & Tropical Medicine, and Honorary Professor of International Health
Paul E Morris, Academic Clinical Fellow in Infectious Diseases at the University of Sheffield, UK, & Lorenzo Cladi, Lecturer in International Relations at the University of Birmingham, UK
Sheffield Hallam University
Department of Infection & Tropical Medicine, Royal Hallamshire Hospital, Sheffield S10 2JF, UK
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Whatever happened to medical common sense?

Four new oral anticoagulants (NOAC) are available in Japan: Pradaxa (Prazaxa in Japan, anti-thrombin inhibitor, Dabigatran, Boehringer Ingelheim) and three anti-factor Xa inhibitor, Xarelto (Rivaroxaban, Bayer), Eliquis (Apixaban, Pfizer) and Lixiana (Edoxaban, Daiichi Sankyo).

NOAC is used instead of warfarin for the prevention of stroke in atrial fibrillation. Selling point of them is “one dose fits all approach” without monitoring and the titration like warfarin.

However a simple question arises; when hypertensive patients were given only one fixed dose drug and drug companies ensured that blood pressure would be normalized without monitoring blood pressure or diabetic patients were told that blood glucose level could surely be well controlled by the fixed dose oral glucose lowering agent without the adjustment by the monitoring of the glucose level or hemoglobin A1c, few believe these advertisements that appear too good to be true. Why did doctors, patients and regulators believe these drugs to be used without monitoring?

If the blood concentration of the drug varies in a considerable way like Dabigatran, there is a good likelihood of extremely higher and lower concentration, which lead to the bleeding and ischemic stroke. The pharmaceutical company should not sell NOAC and the authorities should not approve until the monitoring of the concentration and the activity can be easily estimated in the hospital.

In the Dabigatran case, DTT assay (the Hemoclot test) is available in EU. Thus, also in both US and Japan, the company should have started selling dabigatran after having prepared the assay kit of Dabigatran. The kit now should be equipped as rapidly as possible. The (pretreatment) guideline is useful for patients’ selection, however once Dabigatran treatment begins, there is no other way to prevent patients other than the monitoring. In addition, there is no available antidote, a neutralizing agent. Moreover, verapamil, which is frequently used drug for atrial fibrillation, increases the concentration.

All NOACs at first in the real clinical world should be monitored by the blood concentration or the activity. It should be mandatory at least for high risk patients (elderly patients, patients with impaired renal function or low body weight). After a while, if the monitoring is scientifically proven to be unnecessary, the drug without monitoring should be recommended. If this doesn’t happen, the reputation of drugs, which actually may do much good, will be jeopardized. In reality, what I feared the most may be happening.

Competing interests: No competing interests

20 October 2014
Yoshiki Yui
Cardiology Doctor
Deaprtment of Cardiovascular Medicine
6068397, Shogoin, Sakyoku, Kyoto City
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Non-Contact Infrared Thermometers (NCITs) are being used widely in West Africa as a way to screen for fever and check temperatures without physically contacting the patient, hopefully thus reducing risk transmission of the Ebola virus during the current epidemic. This is especially important as many healthcare workers have become infected and patients also risk spreading the virus to other patients. I have two questions that I think are relevant to this discussion.

1. While I was working in Monrovia, Liberia, recently with local healthcare facilities, we received by donation some NCIT thermometers that were made for industrial use, with a large range of temperatures (BAFX Products, with listed temp range of -50 to 500C). In using them, it seemed that they are registering much lower than others, consistently 30C for example when checking on the forehead or temple of healthy people. I could not find anything in the package insert or on line that says they whether these should or should not be used on people. Do you know if they might be less accurate?

2. What might be the best brand(s) as far as accuracy, and durability, for the NCITs (very important in the hot, humid environment there, where they are often needed outdoors for screening and triage)?

Thank you.

Competing interests: No competing interests

20 October 2014
Paul Bunge
Physician
Medical Teams International
2033 14th Ave SW, Olympia, WA 98502
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We too, are aghast at the developing culture of medical excess. A quest to seek perfection is noble. Yet we have to accept that perfection can rarely, if ever be achieved. Were that the case, intrapartum related still births would never occur and no child would be born with cerebral palsy caused by intrapartum events. However, in human affairs, accidents are normal.

In the aftermath of the melt down of the nuclear reactor at Three Mile Island, the official report commented that “our ability to organise does not match the inherent hazards of some of our organised activities” The worst disaster in the cold war was when a B-52 carrying 4 Hydrogen bombs in 1968 set its self on fire. It crashed into the ice of Greenland and scattered plutonium over three square miles. The cause of the crash? A pilot had placed an extra cushion on the seat. This in turn blocked a heating vent that caused the fire.

In 1785 Robert Burns wrote “The best laid plans of mice and men often go awry”. 229 years later, we still cannot accept this immutable fact. Until we do so, we will find ever increasing medical excess. Hoffman and Kanzaria suggest that changing the culture of medicine and wider culture is required. We believe that there is no need. We live in a capitalist society. When the larger world understands the cost of medical excess, then we believe common sense will prevail.

Competing interests: No competing interests

20 October 2014
Malcolm John Dickson
Consultant Obsyeytician & Gynaecologist
Rizwana Yakub, Sarah Abul-Ainine
Wayside Cottage, Eccups Lane, Morley Green, Cheshire, SK9 5NZ
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