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  #1   ^
Old Sun, Mar-24-19, 01:34
Demi's Avatar
Demi Demi is offline
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Default Statins war of words

Quote:
From The Independent
London, UK
22 March, 2019

Statins war of words: Matt Hancock dragged into ongoing debate over cholesterol-lowering drug taken by millions of Britons

More than six million people in the UK take statins, but the arguments continue over whether everyone should be on them.


Few drugs polarise the academic and medical world like statins – the most commonly prescribed medicine in the UK with at least six million people taking the cholesterol-lowering drugs. In recent days, the debate surrounding statins has seen daggers drawn once more with even the Health Secretary dragged into the latest war of words.

Earlier this month a “devastating investigation” in the Mail on Sunday claimed to unmask a group of high profile “statin deniers” who were spreading “deadly propaganda” about the drug. Dr Aseem Malhotra, an honourary NHS consultant cardiologist at Lister Hospital Foundation trust in Stevenage, Hertfordshire, and in private practice, Dr Zoe Harcombe, an academic whose research focuses on food and nutrition, and Dr Malcolm Kendrick, a GP from Cheshire, who says people are “being conned” over statins in his recent book on the subject, were the focus.

The article said the “noisy group of sceptics” are responsible for putting people off taking statins who would otherwise benefit from them. Matt Hancock was approached for comment – the only problem was he was not told the article would be attacking Dr Malhotra, who met the Health Secretary in Westminster at last month’s All Party Parliamentary Group for Diabetes meeting, and Dr Harcombe.
Mr Hancock sent a direct message on Twitter to Dr Malhotra saying he had “no idea” the paper would link statins denial to the pair.

“I have never denied statins can be beneficial,” Dr Malhotra told i. “The key point about the statins is: will the benefits outweigh the side effects of the drugs for the patient? And in many cases they don’t. But most importantly is ensuring patients are fully aware of absolute benefits and risks so they can make an informed decision on whether to take or stop the drug. This is the ethical practice of true evidence based medicine.”

During a recent TalkRadio interview with Eammon Holmes, Dr Malhotra said it is “completely false” to refer to him as a statins denier. “What I advocate is lack of transparency in their prescriptions. This is about patient choice, good science and the ethical practice of medicine,” Dr Malhotra said.

The 59-year-old presenter revealed he had been taking statins for five years until recently. He said: “I woke up most days having taken my [statins] tablets and feel like crap. I feel fatigued. I continually forget things.” Having stopped taking statins two months ago, Holmes said he felt better “day by day”, adding: “I feel like the old me.”

‘Distorted and defamatory’

The media war of words goes back further. Under the headline “Butter nonsense: the rise of the cholesterol deniers”, a Guardian article in November targeted Dr Malhotra – a regular Guardian (and i) contributor – for his “strong views” of statins. For personal reasons Dr Malhotra was unable to respond at the time, but in a letter sent today to Guardian editor Kath Viner has called for a retraction calling the article “misleading, distorted, inaccurate and defamatory”.

He wrote: “And unless it is fully retracted online I believe it will continue to cause significant damage to public health with a negative effect on millions of people.”

Fiona Godlee, editor in chief of The BMJ, told i: “The debate about who should take statins is clearly still very much alive. The Guardian article seemed to be a blatant attempt to suppress that debate by attempting to discredit those who question the merits of statins in people at low risk of heart disease. The article was misleading and fell well short of the standards for accuracy or impartiality expected of a credible and trusted publication. I believe it needs at least very substantial correction.”

Oxford University’s Professor Rory Collins, who has published many papers on the benefits of statins, has accused Dr Malhotra and others of endangering lives by putting people off taking the drug.
In a 2016 review he carried out on statins analysing all the published trials on the drug over a 30-year period, published in the Lancet, Professor Collins said: “Our review shows that the numbers of people who avoid heart attacks and strokes by taking statin therapy are very much larger than the numbers who have side-effects with it.”

The review concluded that lowering cholesterol over five years with a cheap daily statin would prevent 1,000 heart attacks, strokes and coronary artery bypasses among 10,000 people who had already had one. It would also prevent 500 in people who were at increased risk, for instance because of high blood pressure or diabetes.

Following accusations that previous statins trials “hid” data on adverse side effects, Professor Collins and a colleague have now requested every single adverse event in all the major studies and plan to publish the first analyses of these data later this year.

Between 2006 and 2016 statins prescriptions increased 68.6 per cent, due in part to the substantial growth of generic prescribing as more drugs became available for cheaper on the NHS. Dr Malhotra said he has prescribed statins and managed “thousands of patients” on the drug over the course of his career so has a first hand experience of their effects.

“I know what they’re absolute benefits are,” he said. “If you have a low risk of heart disease, or are otherwise relatively healthy… statins will not prolong your life by one day. And most of the people in the world taking statins are in this category.”

Quote:
What are statins?

Statins are a group of medicines that can help lower the level of low-density lipoprotein (LDL) cholesterol – so called “bad cholesterol” – in the blood. Statins reduce the production of LDL inside the liver.
Having a high level of LDL is potentially dangerous, as it can lead to a hardening and narrowing of the arteries (atherosclerosis) and cardiovascular disease (CVD), a general term that describes a disease of the heart or blood vessels. CVD is the most common cause of death in the UK and kills about 150,000 people in the UK each year.

The main types of CVD are coronary heart disease, angina, heart attacks and stroke. Your doctor may recommend taking statins if either you have been diagnosed with a form of CVD, or your personal and family medical history suggests you are likely to develop CVD at some point over the next 10 years and lifestyle measures have not reduced this risk.

The NHS says that the risks of any side effects, such as such as diarrhoea, headache, fatigue or feeling sick, also have to be balanced against the benefits of preventing serious problems. A review of scientific studies into the effectiveness of statins found that around 1 in every 50 people who take the medication for five years will avoid a serious event, such as a heart attack or stroke, as a result.

The NHS also says your doctor should discuss the risks and benefits of taking statins if they are offered to you. Doctors should also recommend lifestyle changes – such as changes to diet, exercise or reducing alcohol intake – to reduce the risk of developing CVD before they suggest that taking statins.


In 2014, the National Institute for Health and Care Excellence (NICE) recommended that preventative treatment for cardiovascular disease (CVD) should be halved from a 20 per cent risk of developing the disease over 10 years to a 10 per cent risk. A BMJ article in 2017 said that almost all men over 60 and all women over 75 in England – 12 million people – qualify for statin prescriptions under the updated guidelines.

Almost 20 articles have been written about statins across national print and web in the last week alone as research into the drug continues apace. An international study published this month said a new type of drug – called bempedoic acid – could offer another weapon in the fight against bad cholesterol. It suggested the pill lowers cholesterol in people who continue to have high levels despite taking other drugs such statins.

And scientists suggest the new therapy may also work as an alternative for people who are unable to take statins because of side-effects. Researchers, who published their findings in the New England Journal of Medicine, say they have asked UK and US drug regulators to consider whether to approve the pill.

Responding to the research Professor Sir Nilesh Samani, medical director at the British Heart Foundation, said: “Research has shown a clear link between cholesterol and heart disease. People with high cholesterol levels may need to combine medication along with a healthy lifestyle to bring these levels down.

“On the whole statins do a great job of lowering cholesterol. However, this new drug could provide real benefit for the few people who can’t take them or require additional treatments to get it to the right level. The research suggests that it has the potential to reduce risk of heart attacks and strokes without major side effects.”

Row rumbles on

What is certain is that the great statins debate shows no signs of going away.

Sir Richard Thompson, past president of the Royal College of Physicians, said: “Attacking doctors who genuinely hold opposite views , such as labelling them ‘cholesterol or statin deniers’, should be no part of this healthy debate; rather we must all try to move towards a scientific consensus for the benefit of patients.”

Professor Samani said: “While there may be some debate to be had about the level of risk a person should reach before being prescribed statins, there is overwhelming evidence to suggest that statins save lives of those at a relatively high risk of heart attack or stroke, especially people who have already suffered one of these events.

“There is a natural interest in statins as they are one of the most widely prescribed drugs in the UK. Although their benefit is largely invisible to the people taking them, there is a wealth of evidence that proves they save lives by reducing a person’s risk of a deadly or disabling heart attack or stroke.

“We know that negative and conflicting reports in the media can stop people from taking their prescribed statins. While recent headlines might lead people to question their statins prescription, the reality is the benefits of taking statins far outweigh any risks, especially in patients who have had a previous heart attack or suffer with coronary artery diseases.

“If you are taking statins and have any concerns, consult your doctor who will base their advice on objective interpretation of the best evidence available.”


Read more at: https://inews.co.uk/news/health/sta...a-rory-collins/
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  #2   ^
Old Sun, Mar-24-19, 07:38
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WereBear WereBear is offline
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There’s no science supporting what statins DO. They are screwing with a fundamental body process based on inadequate data.

Quote:
Responding to the research Professor Sir Nilesh Samani, medical director at the British Heart Foundation, said: “Research has shown a clear link between cholesterol and heart disease.
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  #3   ^
Old Sun, Mar-24-19, 08:35
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bevangel bevangel is offline
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If ONLY the underlying data regarding adverse statin"s effects were available for independent review.


Below is a relevant article from the BMJ website that discusses the problem. (This article is undated but at one point indicates that, as of February 2019, many of the investigator's requests for data from clinical study regulators were "still pending" which suggests that the article has at least been updated recently.)

Quote:
Statins - a call for transparent data

Do the benefits of routine use of statins to individuals at low risk of cardiovascular disease outweigh the harms? This debate has proceeded for 4 years despite a lack of transparency of the underlying evidence base. Independent review of underlying participant level data from all clinical trials should be a necessary first step to answering this important question. The BMJ remains committed to clarifying who has access to the participant level data and how these data might be made available for independent analysis.

The BMJ’s call for independent scrutiny of statins trial data emerged following a debate over two statins articles (Abramson et al. and Malhotra) the journal published in 2013. The articles were critical of proposals to extend the routine use of statins to individuals at low risk of cardiovascular disease (i.e. primary prevention), and argued that the benefits were less than has been claimed and risks greater.

The articles were most forcefully criticized by Professor Rory Collins, professor of medicine and epidemiology in Oxford and head of the CTT Collaboration, whose data had been reanalyzed by Abramson and colleagues. Collins alerted The BMJ to an error regarding a statistic that appeared in both papers on the frequency of adverse events and called for both articles to be retracted.

In May 2014, formal corrections were issued and editor in chief Fiona Godlee convened an independent panel to judge whether or not the articles should be retracted.

After a two-month review, the panel advised The BMJ that its handling of the two articles was appropriate and that its processes were timely and reasonable. (Read the full report of the independent statins review panel, and The BMJ's response to their recommendations.)

The panel called for anonymised individual patient data from the clinical trials of statins to be made available for independent scrutiny. Of particular interest was the extent of benefit from statins to people at low risk of heart disease, and whether the harms of statins have been characterised adequately in the trials.

In October 2014, Collins complained to the Committee on Publication Ethics (COPE). The BMJ has published documents relating to this complaint. The documents outline COPE’s deliberations on the concerns raised and The BMJ’s response, and come to a clear conclusion that The BMJ “acted appropriately” in its handling of the articles which questioned the use of statins in people at low risk of heart disease.

The controversy flared again in September 2016 following a review published by Collins and colleagues in The Lancet which concluded that trials demonstrate that the benefits of statin therapy in primary prevention of cardiovascular disease outweigh the harms.

Harlan Krumholz, Professor of Medicine at Yale University and member of the independent statins review panel, agrees on the strong case for the overall benefits of statins, but he wants more acknowledgment of the trials’ limitations and argues that “sharing the data is more likely to settle the debate than another review.”

Fiona Godlee concurs, arguing that independent scrutiny of the statins trial data remains an essential next step if the increasingly bitter and unproductive dispute is to be resolved.

Seeking the data, 2014-2016

There is little debate about the benefits of statins in those at high risk of cardiovascular disease. The debate is instead about the rates of less serious side effects (especially myalgia and low grade myopathy) in individuals with lower risk of cardiovascular disease receiving statin therapy for primary prevention. The Cholesterol Treatment Trialists’ (CTT) Collaboration estimates the frequency of myopathy at 5 cases per 10,000 statin users over 5 years. Others disagree, like Richard Lehman, retired GP and Senior Advisory Fellow in primary care at Cochrane UK, who says that adverse effects are much more common than the trials suggest. “Rather than discount a widely observed phenomenon, we should ask why there is such a mismatch with reporting in the trials,” he writes.

In August 2014, The BMJ committed to clarifying who has access to the patient level data and how these data might be made available for independent analysis.

We began by writing to Rory Collins (of the CTT Collaboration), asking him to clarify which data from the statin trials CTT has access to. The reply from Collins and colleagues confirms that the CTT Collaboration's access has been limited to patient level data on cause specific mortality, major vascular events, and site specific cancers. The collaboration had not analysed data on other adverse events as these were not part of the original CTT Collaboration agreement. Collins and colleagues explained, however, that the trialists agreed in 2013 to pool and analyse data on all adverse events. More details can be found in this editorial.

Godlee also wrote to the Cochrane review group on statins, asking whether it would be seeking access to the patient level data for its next update. The response from Mark Huffman and colleagues does not confirm this.

The BMJ also wrote to the principal investigators of the trials included in the CTT analysis, asking them whether they have the patient level data and under what circumstances they would be willing to share them. The BMJ's letter and the replies as we have received them are posted below, as is a record of the status and nature of responses for each trial.

By June 2016, eight researchers had responded. All said they were potentially willing to share their data with other researchers. Members of the journal’s expert advisory group (detailed below) contacted some authors of 183 statins trials, with the aim of characterising adverse outcomes from both published and unpublished information.

This is a substantial undertaking, in which The BMJ is grateful for guidance from its advisers. In the interests of transparency, the minutes of our discussions, and competing interests forms for each panel member, are publicly available.

We welcome comments and ideas from readers via rapid responses.

Seeking the data, 2018-present

The BMJ is also tracking the efforts of Tom Jefferson who has focused on obtaining clinical study reports from regulatory bodies that have approved statins in primary prevention as a first step necessary to evaluate the question of what trials can--and cannot--say about the debated harms.

Jefferson started with the EMA in 2016, but soon found that the EMA lacks any data holdings for many statins which came to market through European national regulators. Jefferson also found that no single national regulator holds the full set of data for all statins, and began seeking trial data from four European national regulators.

Many of his requests are still pending as of Feb 2019 (see table).

Table: Jefferson’s requests (with outcome) for clinical study reports from regulators (as of Feb 2019)

Regulator__________ Country__________ Date________ Outcome

EMA______________ European Union ___1 Dec 2016____ Some CSRs for Cholib, Pravafenix and Lipobay

FIMEA_____________ Finland__________ 27 July 2018__ Refusal to provide data

BfArM_____________ Germany_________ 21 June 2018__ Awaiting definitive answer regarding Lipitor, Mescol, and lovastatin despite numerous hasteners

MHRA_____________ United Kingdom____ 23 July 2018___ Documents for 2 pitavastatin trials delivered 17 August 2018

MEB______________ Netherlands_______ 29 June 2018__ Documents for 1 Crestor trial delivered 28 October 2018

Health Canada______ Canada___________ 26 July 2018___ Currently preparing release of all CSRs for 6 statins (as of Feb 2019)


Abbreviations BfArM: Federal Institute for Drugs and Medical Devices; CSR: clinical study report; EMA: European Medicines Agency; FIMEA: Finnish Medicines Agency; MEB: Medicines Evaluation Board; MHRA: Medicines & Healthcare products Regulatory Agency.

The advisory panel (2014-2015)
  • Peter Doshi, assistant professor at the University of Maryland, and associate editor at The BMJ;
  • Curt Furberg, professor emeritus of public health sciences at Wake Forest University School of Medicine;
  • Fiona Godlee (chair), editor in chief of The BMJ;
  • Peter Gřtzsche, director of the Nordic Cochrane Centre;
  • Carl Heneghan, director of the Centre of Evidence Based Medicine at the University of Oxford;
  • Harlan Krumholz, director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation;
  • Klim McPherson, visiting professor of public health epidemiology at the University of Oxford;
  • Emma Parish, editorial registrar at The BMJ; and
  • Huseyin Naci, assistant professor of health policy, London School of Economics and Political Science, London (joined 6 March 2015)The trials
  • † These trials have been included in CTT meta-analysis (either first cycle or second cycle). Outcome data shared with the CTT on individual patients are limited to cause specific mortality, major vascular events, and site specific cancer.





    Admin



    Minutes of the meetings held by the advisory panel.

https://www.bmj.com/campaign/statins-open-data


Until all data regarding ALL reported adverse effects is made available for independent review, all we (and doctors) have to go on is the manufacturers' word that adverse effects (like myopathy) are very rare.
Quote:
The Cholesterol Treatment Trialists’ (CTT) Collaboration estimates the frequency of myopathy at 5 cases per 10,000 statin users over 5 years.
That "estimate" strikes me as amazingly low given that I personally had HORRENDOUS myopathy (muscle pain) issues that struck within a month of starting taking a statin and I also personally know three other people who also quickly developed myopathy when they started taking statins... myopathy that then resolved when they quit the drug. Statistically speaking, if the CTT's estimates are correct, for me to personally KNOW 4 people (counting myself) that suffered adverse effects from statins, I'd need to personally know close to 8,000 statin users! I'm a friendly person but 8,000 people? I don't think so! :lol; You gotta hope that doctors, hearing from numerous patients that the statins they're prescribing are causing muscle pain, would also start wondering just how accurate those CTT "estimates" are. I know doctors can be horribly busy but I doubt ANY of them see anything approaching 2,000 to 4,000 patients... but I bet every doctor who regularly prescribes statins has had at least 1 or 2 of them complain about myopathy.
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  #4   ^
Old Sun, Mar-24-19, 11:05
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Meme#1 Meme#1 is offline
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What happened to "Do no Harm" ?
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Old Sun, Mar-24-19, 11:08
CityGirl8 CityGirl8 is offline
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I also heard Dr. Malhotra say in an interview that the study data isn't even 100% reflective of adverse effects even when they can get ahold of it--people drop out because of adverse effects and so they are reported as drop outs or not completing the study. Adverse effects are sometimes only reported for people who complete the study.
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Old Sun, Mar-24-19, 11:16
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WereBear WereBear is offline
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Out of 10 statin users I’ve talked to, there will be 3 at least telling me about their pain, and one who leans close and asks if I’ve ever heard of memory problems with it.
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Old Sun, Mar-24-19, 14:03
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mike_d mike_d is offline
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There is a clear link between open umbrellas and rain storms too.
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