Good luck in the exams!

success baby

 

The interviews are over and I will be taking a break till the Autumn. Good luck -you can do it and get those grades!

 

 

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Ethical Scenario -Whistleblowing.

whistleblowers-cartoon

The Whistleblower’s dilemma

 

You have a great job with a well known accountancy firm in the city. The accountancy firm sponsored your degree. You are working on the tax returns of an important client and you notice there are discrepancies in the accounts. You have brought them to the attention of your boss who tells you to ignore them and not to ever mention this matter again. What issues arise here?

Fraud occurring within an organisation is known as corporate fraud.  This involves deliberate dishonesty to deceive the public. This appears to be happening in this scenario. It may be helpful to see the scenario from all points of view:

The Company

Good companies should have a whistle-blowing policy. This allows employees to raise concerns about malpractice within the organisation which may be leading to loss of income or may lead to substantial fines if the company or company workers were found to be engaging in malpractice. It would work to the advantage of the employers in preventing employees engaging in external whistle-blowing which, if it happened, could undermine the credibility of the organisation. Action may pre-empt further abuses and lead to greater transparency within the organisation. PIDA [Public Interest Disclosure Act]-is an employment law act that protects workers from detrimental treatment or victimisation from their employer if, in the public interest, they blow the whistle on wrongdoing.

The Boss

It is very hard to approach your boss and effectively accuse them of dishonesty. Most whistle-blowers sacrifice their career and end up being slandered and victimised despite PIDA which [see above] is supposed to protect them. It would be best to make your concerns to him in writing [email] and avoid ‘discussions’ for which you will have no solid proof.

You – the new employee

You must report your concerns first to your boss and if you feel you have not got a satisfactory response you need to notify those further up the chain of command.

If this is also not successful then it should be reported to a third party such as The Serious Fraud Office. You could contact your Union if a member. Whistle-blowing can lead to alienation at work and termination from the job. Co-workers sometimes perceive whistle-blowing as “snitching” or as a betrayal of the organisation and its members. Four out of five workers end up being sacked or leaving [often with a gagging clause inserted in a termination agreement]   and only 1 in 5 whistle-blowing claims are apparently successful.

Society

The major ethical principle of Justice invokes fairness. Fraud is not fair. If as in this case someone is not paying their taxes as they should, then society loses out as there is less money for public services. It has been said that the economic crisis in Greece is partly due to the fact that so many, particularly the wealthy, avoid tax.

The diagram below is ‘the whistle-blower’s cross’. Being a whistleblower often leads to the hardships described in figure2

whistleblowers cross

 

Gene editing is here.

genetic engineering

Two year old Layla was declared free of leukaemia last week. She was saved after researchers took ‘scissors’ to a donor’s immune cells, in June 2015 and added new genes that would help her fight the cancer that was seemingly unstoppable even in the face of maximum chemotherapy.

layla richards

Last  week scientists in the USA started  gene editing in sperm, eggs and embryos to prevent inherited disorders such as cystic fibrosis and Huntingdons.

Gene editing has become cheap and easy by CRISPR – an exciting  biological system for altering DNA. Prof Dupre of the Nuffield Council describes CRISPR as “satnav with scissors”, because it uses proteins to cut DNA at a precise, targeted location.Genome editing is the deliberate alteration of a selected DNA sequence in a living cell, A strand of DNA is cut at a specific point and then natural cellular repair mechanisms repair the broken strands.

There are 4,000 known inherited single gene conditions, such as cystic fibrosis. affecting about 1% of births worldwide. Genome editing leads to the possibility of such conditions being treated.In 2015 it was reported that a Chinese team of researchers had corrected disease-causing genetic mutations in non-viable embryos, so they were not allowed to develop. The UK’s Human Fertilisation and Embryology Authority (HFEA) also granted a licence in February 2016 to allow genome editing of embryos in the UK.

There are obvious concerns, such as the potential risks of unintended consequences of changing DNA and the implications for future generations. There is the worry  of ‘designer babies’ where gene editing is used to produce attractive characteristics rather than treat serious conditions

The Nuffield Council said discussing ethical issues now would aid public understanding of the new technology. Scientists were taken aback by public opposition to GM foods and needed to take the public along with them this time.

There are a number of ethical issues but advances in genetics have created an unstoppable push to use such technologies in humans. Despite the UK parliament passing a law to allow manipulation of mitochondrial DNA to created 3 parent babies the US beat the UK and a baby boy containing genetic information from 3 parents was born last week. https://www.newscientist.com/article/2107219-exclusive-worlds-first-baby-born-with-new-3-parent-technique/.

Measles and a very sad, true story by Roald Dahl about his daughter’s death.

Measles is back in the news again. The disgraced doctor, Andrew Wakefield who was struck off for fabricating research and concealing payments,was back at a secretive showing of the new film ‘Vaxxed’.  This anti vaccine film by a conspiracy theorist alleges that the CDC [Centre of Disease Control in the US]and the  government suppressed information showing that the measles vaccine causes autism. Unfortunately measles which had been eradicated in the US is now on the rise as fearful parents refuse to allow their children to be vaccinated and they have the sympathy of a scientifically inept President.

Donals Trump tweeted

‘Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!’

Donald Trump has also appointed Robert Kennedy Jr, a prominent vaccine conspiracy theorist, to chair a commission on “vaccination safety and scientific integrity”.

MEASLES: A dangerous illness by ROALD DAHL

roald dahl 1

Olivia, my eldest daughter, caught measles when she was seven years old. As the illness took its usual course I can remember reading to her often in bed and not feeling particularly alarmed about it. Then one morning, when she was well on the road to recovery, I was sitting on her bed showing her how to fashion little animals out of coloured pipe-cleaners, and when it came to her turn to make one herself, I noticed that her fingers and her mind were not working together and she couldn’t do anything.

“Are you feeling all right?” I asked her.

“I feel all sleepy,” she said.

In an hour, she was unconscious. In twelve hours she was dead.

The measles had turned into a terrible thing called measles encephalitis and there was nothing the doctors could do to save her.

That was twenty-four years ago in 1962, but even now, if a child with measles happens to develop the same deadly reaction from measles as Olivia did, there would still be nothing the doctors could do to help her.

On the other hand, there is today something that parents can do to make sure that this sort of tragedy does not happen to a child of theirs. They can insist that their child is immunised against measles. I was unable to do that for Olivia in 1962 because in those days a reliable measles vaccine had not been discovered. Today a good and safe vaccine is available to every family and all you have to do is to ask your doctor to administer it.

It is not yet generally accepted that measles can be a dangerous illness.

Believe me, it is. In my opinion parents who now refuse to have their children immunised are putting the lives of those children at risk.

In America, where measles immunisation is compulsory, measles like smallpox, has been virtually wiped out.

Here in Britain, because so many parents refuse, either out of obstinacy or ignorance or fear, to allow their children to be immunised, we still have a hundred thousand cases of measles every year.

Out of those, more than 10,000 will suffer side effects of one kind or another.

At least 10,000 will develop ear or chest infections.

About 20 will die.

LET THAT SINK IN.

Every year around 20 children will die in Britain from measles.

So what about the risks that your children will run from being immunised?

They are almost non-existent. Listen to this. In a district of around 300,000 people, there will be only one child every 250 years who will develop serious side effects from measles immunisation! That is about a million to one chance. I should think there would be more chance of your child choking to death on a chocolate bar than of becoming seriously ill from a measles immunisation.

So what on earth are you worrying about?

It really is almost a crime to allow your child to go unimmunised.

The ideal time to have it done is at 13 months, but it is never too late. All school-children who have not yet had a measles immunisation should beg their parents to arrange for them to have one as soon as possible.

Incidentally, I dedicated two of my books to Olivia, the first was James and the Giant Peach’. That was when she was still alive. The second was ‘The BFG’, dedicated to her memory after she had died from measles. You will see her name at the beginning of each of these books. And I know how happy she would be if only she could know that her death had helped to save a good deal of illness and death among other children

the-enormous-crocodile-by-roald-dahl

Ethical Dilemma of the week. A fifteen year old girl asks for the contraceptive pill.

You are a GP and you see Millie, a fifteen year old who comes alone. She tells you that she would like to go on the pill. What issues does this raise? How would you handle this scenario? Answer

contraceptive-pill 

Millie should be asked why she wants to go on the pill. The pill is often used for other conditions, such as to regulate and control periods and treat acne but it is likely that she is requesting it because she wishes it to be used as a contraceptive.

Using the  4  ethical pillar framework [see P74-79 Medical School Interviews – The Knowledge ]

What does the law say? [Justice]

Millie is fifteen; younger than the age of consent [16yrs]. Her parents are almost certainly her legal guardians. If she is having sex with a man over the age of 18 that man can be accused for child abuse as she is still legally a child. However see the Fraser Ruling below on contraceptive prescribing.

Beneficence – A doctor should always act in the patient’s best interests.

Sex before the age of consent is common in this country and the rate of teenage pregnancies and sexually transmitted diseases in the UK is higher than in any other European country. Millie has shown that she can be responsible by seeing her doctor. It is important for the doctor to establish a good relationship with Millie, to be someone she feels she can trust. Millie is more likely to take the doctor’s advice regarding protecting herself against sexually transmitted disease by using condoms if she feels that she is not misunderstood and patronised. If Millie is going to have sex anyway it would be in her best interest that the risk of pregnancy and sexually transmitted diseases is minimised.

Maleficence [Harm]

There is no evidence that prescribing contraception increases teenage sexual intercourse levels – however this is contentious. Evidence exists to show that good contraceptive access decreases teenage pregnancies. The side effects of the pill are usually minor and serious side effects rare in most girls but risk factors need to be screened for by the doctor.

Autonomy

Under the Gillick Ruling and Fraser Rules if Millie can demonstrate that she understands the risks of sex at such a young age and the risks of treatment with the pill then she has competence and therefore autonomy.  The Fraser rules [see below] state that the doctor should question Millie to see if she has full understanding and try and persuade her to involve her parents. However if she is adamant that she does not want them to know then she has the right to confidentiality. If the doctor feels that there is a strong likelihood of sex occurring any way then he should prescribe her contraception.

Fraser Ruling and Gillick Competence

Mrs Gillick took her Health Authority to court because they were supplying contraceptives to under 16yr olds without informing parents. She had 5 daughters and felt that she had a right to know if they were being prescribed anything.

The case went to the House of Lords. The judges, chaired by Lord Fraser, ruled that if a child was competent and had autonomy then their confidentiality was to be respected [i.e. their parents did not need to be informed] if they fully understood all the risks. The doctor should try to persuade the child to talk to her parents but if the child insisted she did not want to, they did not need to be informed. In the case of contraception the doctor had to feel that there was a strong likelihood of sex occurring anyway. The doctor should always consider the possibility of sexual abuse [which should be always reported].

This case led to the term Fraser Rules and Gillick competence.

A child is ‘Gillick Competent’ if he/she is mature enough to have understanding of what is involved – there is no arbitrary age limit.

 These rules apply to all medical procedures not just contraception and abortions. A ‘Gillick competent’ child can give consent to have a procedure against the wishes of her/his parents and has the right to confidentiality.  (see earlier ethical scenario on  The Jehovah Witness Boy)

Under Pressure

A and E images 2

Ambulances  waiting outside A and Es which are full of patients waiting to be found beds on already full wards

It has not been a month since Jeremy Hunt and Theresa May rejected comments by the British Red cross that the UK was facing a ‘Humanitarian Crisis’ in health and social care. The Government cut back funds to councils who pay for social care for elderly/frail patients discharged from hospital.  As a result there are delays in discharging patients who are sometimes disparagingly referred to as bed blockers. Bed occupancy is now about 90% on average. A safe level is thought to be 85% .

A nursing home bed costs  between £800 – £1100 a week; an acute hospital bed three times that amount but it comes from the NHS budget.  Hunt and May announced that foreigners should be charged for using the NHS and GPs should open 7 days a week. However scapegoating GPs and foreigners will not make ‘beds appear’. Seriously ill patients still need to be admitted.

 

Extract taken from ‘The Secret Doctor’ Blog  BMA

There were no beds.

I was in resus at 9pm with a young person who had been intubated and ventilated to keep him alive following an overdose. We’d been told the closest bed was forty miles away, but the sister on critical care phoned around the local units and eventually negotiated a bed somewhat closer.

The parents waited anxiously to be told where our NHS could manage to fit their son in, their son who had almost lost his life completely in the last hour. I watched the relief on their faces when they were finally told we only had to move him ten miles away.

Meanwhile, we had been alerted to another critical patient less than ten minutes out, so the daytime registrar, who had already finished his shift, stayed to do the transfer. Nobody else would be free.

I scanned down the line of resus bays and they were all full. I shot the A&E consultant a concerned look and he assured me they were moving one out. The health care assistant was just packing them up, so I helped her push the trolley around to major injuries.

We negotiated past the row of patients in the corridor. ‘Cubicle 10,’ the coordinator shouted, but when we got there is was already occupied. They were all occupied.

‘I’ll sort it out’ the coordinator assured me, so I hurried back around to resus.

The next patient was post cardiac arrest, but he had been shocked and stabilised, so we intubated him and got him ready for an urgent coronary angioplasty. That angioplasty would save his life, but when I handed him over to the anaesthetist I knew I would still have no bed for him when he came out the other side.

I moved on to the next resus bay; an elderly man was on 100 per cent oxygen and hypoxic. His family sat around him and he struggled still to breathe despite non-invasive ventilation assistance that had been started as a temporary holding measure. I was there to assess whether he stood to benefit from admission to intensive care. They tell you this assessment is always done independently, that it should not be tainted by capacity problems.

Question 1: Do they need admission?

Question 2: How can I facilitate it?

I believed that entirely, but the reality… there were no beds.

The consultant came and it was decided the patient would not benefit from escalation to intensive care.

I agreed it was the right decision for the patient but I was also genuinely relieved this was the decision, that he didn’t also need a bed I didn’t have.

The second patient returned from angioplasty and stayed in the theatre recovery area all night. An on-call anaesthetist took herself away from emergency theatres to stay with him.

Morning time came and there was still no bed, so we transferred him to another hospital too.

Pass the parcel… pass the patient, but this was not a game and I didn’t enjoy it.

The next evening I arrived for night shift number two. ‘I’m sorry,’ the charge nurse said, ‘the day SpR is in resus with an intubated patient and I just have no bed for him, I think you’re going to be there all night’.

And so it continued.

The drunk consultant scenario.

 

 

why-be-a-doctor

You are a junior doctor and your consultant [your boss, the head of your team] arrives for the morning ward round smelling of alcohol. You confront him and he confides in you that he was drinking because he was upset because his wife left him the day before and asks you not to tell anyone. How would you handle this situation?

It is important to consider this scenario from the view point of all involved.

Your consultant’s point of view: He is going through a difficult period in his personal life and now by coming to work in this fashion he is jeopardising is career and standing in the hospital. However it is much better that he takes sick leave, the stress as well as the drinking would make it hard to concentrate and mistakes which in medicine can have terrible consequences are almost bound to happen. He should not feel that it is a weakness to seek help, we are all vulnerable and there are services such as occupational health, BMA counselling services that are available free of charge to doctors. It is important that he has insight and does not worsen his situation by trying to ‘soldier on.’

The hospital/NHS point of view:  The hospital has a reputation to protect and will be sued for any mistakes made. If the consultant is off hand or rude this may lead to complaints. It certainly cannot have its staff coming to work intoxicated. However the consultant is a very skilled, experienced member of its workforce and has given many years of loyal service so be treated with empathy and compassion. He should be encouraged to use the counselling services available and given time off work but it should be made clear that coming to work in this manner is unacceptable.

The patient’s point of view: – the most important. Patients have the right to be treated safely and courteously by attentive staff  that have their full wits about them. Medicine has the potential to cause serious harm as well as good.

Your view point: As a junior doctor your consultant is your team leader, mentor and teacher. He will also be the person who will give you a reference for future jobs. It is therefore important to still treat him with respect and courtesy. He as a person going through a difficult time deserves sympathy and empathy. However you have a duty to your patients and patient care and safety trumps all – ‘make the patient your first concern.’ It would be going against the GMC rules and probably hospital policy if you tried to cover up, even if no one came to harm. It may be the first time you have seen him like this but other occasions may have occurred and there may be a repeating pattern.

You should ensure that your consultant stops working, that he goes home [by taxi, does not drive]. That all patients he has seen have their notes reviewed, that you inform the relevant authority and seek help with that day’s work.

Abortion.

trump-abortion

President Trump signing papers restricting abortion.Where  are the women?

The topic of abortion has been in the news this week. It is the 50th anniversary of the Abortion Act  in the UK and President Trump bought in legislation a few days ago to  stop Government funds going to any organisation that provides counselling for abortion. This would stop funds going to most NGO s all over the world that are involved in women’s health and provide contraception, pregnancy and obstetric services and HIV aid for women. Changes in the funding of US health care agencies such as Planned Parenthood will also make obtaining contraception and legal abortion harder in the USA, particularly for the poor.

The  Rebuplicans won both houses of Congress and Trump has said that he would nominate ‘pro-life justices’ [there are likely to be as many as three vacancies] to the Supreme Court. Even one pro-life justice appointment may change the present balance and lead to the over throw of  the court’s landmark 1972 Roe v Wade decision that established a woman’s right to an abortion in the US.

We know that bans on abortion do not work.  Paradoxically countries that have strict bans on abortion tend to have the highest abortion rates because of widespread illegal abortions and often poorer access to contraception.  Western Europe has the world’s lowest abortion rates despite having better access to abortion. In countries with bans, women who can afford to pay still manage to find doctors willing to carry out abortions, usually for large sums of money and the poor resort to dangerous ‘back street’ abortions. When the Steel Bill that established the Abortion Act in the UK was bought in, the number one cause of maternal mortality [women dying in pregnancy] was illegal abortions.

abortion

Abortion is a very emotional subject. It is the only procedure that a doctor can opt out off in the UK. When taking about abortion remember that your personal beliefs should not affect your treatment of a patient. Even if you disagree with a patient who requests an abortion the GMC makes it clear that patient should be treated with consideration and empathy. It may be reasonable to ask her to consider other options if she does not seem completely sure  but she has the freedom to make her own mind up and there should not result in any significant delay.The patient should be quickly referred to a colleague who is willing to help her.

The Abortion Act 1967 [UK] makes abortion legal if the following criteria are agreed by 2 doctors.

1 If the pregnancy has not  reached 24 weeks  and there is  greater physical or mental risk of harm to the mother or her existing children and family by continuing the pregnancy.

2. At any stage if there is serious risk to the health of the mother

3. At any stage if the foetus is likely to be born with severe physical or mental abnormalities.

Pregnancy and delivery are more dangerous than a termination so reason number one suggests that provided the pregnancy has not gone far there is effectively abortion on demand. However late terminations, beyond 12 weeks are rare. 90% are before 12 weeks in the UK.

The major organs are formed by 12 weeks. We think that the foetus may begin to feel pain at 20 weeks when the nervous system begins to mature. When recognisably human life truly begins is very controversial.

President Trump. His first few days.

make-america-kind-again

100,000 of us went on the anti Trump rally on Saturday in London!

Obamacare

One of President Donald Trump’s first actions was an executive order aimed at trying to roll  back Obamacare. Obamacare resulted in healthcare for 20 million Americans who had been previously uninsured and without access to healthcare. About 200 million Americans are also possibly going to lose benefits because  many  benefited indirectly by forcing their insurance companies to cover them for all conditions and the Trump administration has announced that  1 trillion dollars will be wiped off the Medicare [the scheme for the elderly] and Medicaid budget.

As yet there has been no disclosure about what may replace it. Tax hikes on the very wealthy [those that earn over $250,000] which were used to pay for it will be abolished. The  Obamacare pushed up ‘skinny’ premiums; those for fit, males without preexisting illnesses. It effectively involved significant transfers — from the rich to the poor, the healthy to the sick, the young to the old. As a result some people lost out and resented higher premiums. However universal health care is considered normal in all other health care systems in developed nations and such transfers are part of these systems. I would consider this an essential part of a civilised society

Vaccination

Donals Trump tweeted

‘Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!’

Donald Trump has appointed Robert Kennedy Jr, a prominent vaccine conspiracy theorist, to chair a commission on “vaccination safety and scientific integrity”.

As a doctor I know how devastatingly  effective an easy it is is to sow seeds  of doubt in anxious parents’ minds. NO link between Autism and vaccination has ever been found. I doubt whether Donald Trump could even be bothered to read  [certainly not understand] the results of a Cochrane review of trials. Vaccines have been said to have saved as many lives as antibiotics. Some of the most feared diseases such as smallpox, measles, whooping cough, diptheria, tetanus, polio, meningitis [- I could go on and on] have been stopped in their tracks by vaccinations. Vaccinations are even more important now that we have increasing antibiotic resistance!

Planned Parenthood

It is rumoured that Trump plans to defund Planned Parenthood on the anniversary of Roe v Wade  [the controversial Supreme court judgement that made abortion legal in the USA ]. Millions of mostly low-income people who rely on Planned Parenthood for essential health care such as birth control, cancer screenings, STI testing and treatment, well woman examinations and more would no longer have access  And people who already face  barriers to getting care, especially people of colour and people in rural communities, would face additional hurdles. At present Planned Parenthood relies on the Government for 40% of its funding, the rest comes from donations. This is a further attack on women, particularly poor women. It is impossible to plan careers, independent lives without control of your fertility.

Trump’s appointments  Tom Price, Trump’s chosen health minister avoided straight answers when asked about the cuts to Medicaid and Medicare.He bought shares in the tobacco industry and then bought in a bill a week later to stop measures that would negatively affect the tobacco industry. Since being chosen he  bought shares in a hip replacement company 6 days before he bought in a bill that would strongly benefit the company.https://www.youtube.com/watch?v=UY33w3dNU04https://www.youtube.com/watch?v=epxst1Uo8YAhttps://www.youtube.com/watch?v=UY33w3dNU04

girls-just-wanna-have-fun

It is worse than I feared. President Trump is a disaster for all of us who want to improve the health and lives of people around the world. He is racist, misogynistic and has no sense of public duty [boasts that  he pays no taxes.] Within the first couple of days he has introduced changes that have increased the wealth of the super rich and made it so much worse for the needy in society. He has not backed down on his racist rhetoric His team has justified a register of Muslims because a register of Japanese existed during WW2. They  For this reason I joined the Women’s March on Saturday and marched with 100,000 women and men against Trump and what he stands for. [I recommend  watching Ashley Judd’s brilliant speech https://www.youtube.com/watch?v=EXSN-HHowhc ] Does marching have any effect? I agree that Trump will not listen but others might. A few months ago the right wing Polish majority government were about to bring in the most stringent anti abortion laws ever [abortion were not to be allowed even in cases of rape or when the mother’s life was in jeopardy] 6 million women marched – and the law abandoned.  A lot of us are angry. We can’t  take achievements in racism and sexism for granted. Last week the Russian Government repealed laws against domestic violence in order to make violence within the home legal again. Sexism also blights the lives of men [ I recommend http://www.channel4.com/programmes/grayson-perry-allman  http://www.heforshe.org/en]  and stops men having deep more meaningful, loving relationships with women and  deprives them of close involvement in the lives of children.men-of-quality-do-not-fear-equality

There is a lot to do. Trump is the result of a selfish ‘me first’ attitude that is becoming more prevalent in our world. I refuse to allow him and R wing politicians in Europe represent us.  Anger is often viewed negatively but it is a useful emotion if channeled correctly; it gets you up off the ground and energises you but it is just the start of action.  I have since increased  my donations to certain charities I support. I even thought about donating to Planned Parenthood – donating money to the health care system of one of the richest countries of the world – how crazy is that ! I also plan to increase my political involvement. Please do the same -make sure you voice is heard – write,’like’ you tube videos and  posts so they go viral, just get out there, physically or on the internet. Be counted!

Evidenced based medicine rests on shaky ground according to BMJ.

drug trials

Research published today in the BMJ showed that when scientists have financial ties  to a company that make a drug the results of trials are more likely to show the drug to be effective. This is particularly worrying because 58% of ‘principal investigators’ had financial links to the drug company. EBP [evidenced base practice] or EBM [evidenced based medicine] involves looking at trials to decide what are the most effective treatments. It is therefore worrying to think that decisions may be made on such skewed data.

The recent scandal regarding Tamiflu is a very costly example. The Government spent £500 million stockpiling Tamiflu [a treatment for flu] in order to be prepared for a Bird-flu epidemic. Yet as far as we know Tamiflu may be no better than a paracetamol at reducing symptoms. Roche the company who makes it refuses to make information available to doctors from the Cochrane centre. The Cochrane centre was set up by Archie Cochrane who served as a doctor in World War 2 and wrote that he believed that much accepted medical practice had no evidence to support their use. He went further and stated that ‘I was afraid that I shortened the lives of some of my friends by their use.’ He promoted evidence based medicine and set up the Cochrane Library of systematic reviews. It has now become the International Cochrane collaboration and involves over 100 countries [see my book  Medical School Interviews The Knowledge P69 -71 for further information on Cochrane and Evidence Based Medicine]. Researchers looked at the published trials and began to spot discrepancies. Roche seemed unable to answer the simplest questions, such as how many trials had been conducted. Regulators and agencies around the world appeared to have different information on the same drug. One trial was only published ten years after it was completed. The names of those conducting trials seemed to change arbitrarily. There were also concerns about the design of the trials. Some summaries said patients received a dummy placebo sugar pill, when in fact those pills contained an active ingredient. Other research was done on specially selected patients who would be more likely to recover from flu when given Tamiflu than other patients who were given a placebo. But this is no isolated case. Overall, about half of all clinical trials never get published. What’s more, trials with positive results are twice as likely to be shared as trials with negative ones.

The same is true of trials of other treatments such as certain surgical treatments – for example does removing lymph nodes as well as a melanoma reduce the recurrence of melanoma cancer? Lymph node removal can lead to significant swelling of the arms and may not be beneficial. The Halstead operation for breast cancer was one of the great medical scandals.  Halsted developed the radical mastectomy in the 1890s; this procedure removed the breast, skin, nipple, areola, pectoral muscles, and all the axillary lymph nodes on the same side. Even more radical procedures were sometimes used, removing part of the breastbone and ribs to get the internal mammary nodes. These operations would lead to permanent pain, swelling and disfigurement. Trials began to show that recurrence rates were no greater for more limited operations. More was not better! Despite this most surgeons in the USA continued to use the Halstead operation till 1985. Informed consent relies on a patient receiving accurate information and freely making a decision based on that information. If trial information is partially withheld we do not have that information! It is known that about half of all trials are never published These are often the smaller trials with negative outcomes for a drug that a company wishes to promote. A funnel plot can indicate bias. Most results in a systematic review of multiple trials show a normal distribution. However in a funnel plot showing bias the smaller negative trials ‘are missing’

funnel-plot

funnel-plot-2

Many of you will be having medical school interviews in the next few weeks. A common question asked is ‘What would you do to save money in the NHS?’ Well, ensuring all treatments funded by the NHS were evidenced based and preventing over treatment would save money and prevent iatrogenic harm [harm caused by medicine] – a win-win situation!

The BMJ is campaigning and calls on ethics committees, funders [such as the NHS] and institutions not to give approval or host trials or fund subsequent drugs unless all trials are published in full and good time. It is also asking for public support so join in and sign the petition at alltrials.net!