The Great Statin Scam – Time to Clean up the Mess

In October 2013, I published a peer-reviewed editorial in the BMJ entitled “Saturated fat is not the major issue.” The editorial made the front page of three British newspapers and was featured on CNN International and Fox News, among other outlets (1). After analyzing the research for two years and developing my own clinical experience managing thousands of patients with diet-related chronic disease, I concluded incorrect dietary advice was a root cause of the obesity epidemic. To summarize:

1. There was no good-quality and convincing evidence that saturated fat causes heart disease; dairy products high in saturated fat may actually be protective (2).
2. Diets low in refined carbohydrates appear to be most effective for weight loss and managing markers of the metabolic syndrome.
3. Sugar reduction should now be a public health priority to curb obesity and Type 2 diabetes (3).
4. A flawed model of lowering total cholesterol to curb heart disease had resulted in millions being over-medicated with statin drugs that would confer no net benefit. Meanwhile, unacceptable side effects affected about one in five patients taking the medication (4).

Subsequent research has supported the first three conclusions, and progress has been made. For instance, the U.K. government introduced a sugary drinks tax in 2016 following a meeting of myself and a small group of scientists with the Secretary of State for Health (5). However, as far as cholesterol and statins are concerned, we are still trapped in a flawed public policy model that aims to tackle the Western world’s biggest killer by using diet and drugs to get cholesterol as low as possible — all this despite the three-decade campaign failing to reduce population cardiovascular mortality with this approach.

THE SIR RORY COLLINS DISPUTE

A few months after the BMJ publication, British Heart Foundation Professor of Medicine Sir Rory Collins of Oxford University, arguably the most influential statin researcher, called for immediate retraction of my editorial (6). An analysis from John Abramson and colleagues from Harvard appeared in the same issue, wherein Abramson et al. had reanalyzed published data and concluded those at low risk of heart disease received no mortality benefit from taking statins. Although Collins did not challenge this claim, he felt that one in five suffering side effects (which Abramson and I both claimed) was a gross exaggeration. In fact, Collins told The Guardian his own research revealed serious side effects from statins affected only one in 10,000 and there was a small risk of getting diabetes. Collins’ view was that because of media scaremongering, patients at high risk would stop taking the pill, leading to many deaths.

Significantly, The Guardian failed to acknowledge in its reporting of the story that Collins’ department has received well in excess of £100 million from companies that manufacture statin drugs (7).

The editor of the BMJ sent my and Abramson’s articles for an independent review, and a unanimous panel of six concluded there were no grounds for retraction.

Collins, unhappy with this verdict, then reported the editor of the BMJ, Dr. Fiona Godlee, to the Committee on Publication Ethics (COPE) for editorial misconduct, which many inside the BMJ believed was an attempt to get her sacked. Again he was unsuccessful.

Over the next few years, I contributed to a number of well-publicized medical journal articles reinforcing the point that statin benefits are marginal at best and the original trials could not be relied upon to determine the true incidence of side effects.

The true rate of side effects is unknown. In my own clinical experience treating thousands of patients, up to half of them will report a debilitating (although usually reversible) side effect from the medication at some point. This is supported by real-world data that indicates more than half of those patients prescribed statins will stop taking them within a few years, citing side effects as the main reason (8).

To try and settle the debate, Collins reanalyzed his own confidential data in a 2016 Lancet publication, this time concluding the benefits of statins significantly outweigh any potential harms (9).

Weeks later, a quite extraordinary investigation by the Sunday Times newspaper revealed Collins was co-inventor of a genetic test that indicated susceptibility to muscle pain from taking statins (10). This test, branded as “Statin Smart,” was marketed and sold directly to the consumer in the United States under a claim that “29% of all users will experience muscle pain, weakness or cramps.” Although Collins said this figure was misleading, Boston Heart Diagnostics stood by its claims, making the point that clinical trials such as the ones Collins had conducted were unreliable because patients experiencing side effects were often excluded in the final published results. Collins filed the patent for the test in 2009, and a subsequent Freedom of Information request from the Sunday Times revealed Oxford University received in excess of £300,000 for its sale.

A CALL FOR PARLIAMENTARY INQUIRY

After the Mail On Sunday newspaper launched an error-riddled, distorted, defamatory front-page article accusing me, along with Dr. Malcolm Kendrick and obesity researcher Dr. Zoe Harcombe, of spreading “deadly propaganda” on statins, I decided we needed a full public parliamentary inquiry. In order to clear up statin misinformation, we needed to further expose the national scandal developing from the mass prescription of the drugs and push for access to the raw data for independent analysis.

I coordinated a letter with a number of eminent doctors. The BMJ’s Godlee, UCSF Medical Center Cardiologist Rita Redberg, and the Queen of England’s former personal physician and former president of the Royal College of Physicians, Sir Richard Thompson, were all signatories. The letter stated our belief that there was an “urgent need” for a full independent parliamentary investigation into statins (12). We defined “independent” in this context as a review of the complete trial data by experts who have no ties to industry and have not previously undertaken or meta-analyzed clinical trials of statins. To convey the urgency of the investigation, we noted:

• Statins are a class of drug prescribed to millions in the U.K. and tens of millions across the world.
• Based on the publications available, the benefits of statins have been subjected to significant positive spin, especially among people at low risk of cardiovascular disease. Meanwhile, the drugs’ potential adverse effects have been downplayed.

We concluded that all signatories “are strongly of the view that such confusion, doubt and lack of transparency about the effects of a class of drug that is so widely prescribed is truly shocking and must be a matter of major public concern.”

The letter was supported by the chair of the U.K. Parliament’s Science and Technology Committee, Sir Norman Lamb MP, who wrote to the chief medical officer of the country that there was “compelling evidence” such an inquiry was needed (13).

A BETTER UNDERSTANDING OF RISKS AND BENEFITS

A gross injustice continues to be committed against tens of millions of patients around the world who are not given the truth about a pill they are prescribed. We cannot be naïve to the fact that fear of cholesterol is a multibillion-dollar industry and total statin revenues are estimated to reach $ 1 trillion by next year.

Evidence-based medicine dictates that in order to produce the best outcomes for the patient, we use a combination of individual clinical expertise and the best available evidence while considering patient values and preferences (14).

This requires having a conversation with patients that includes transparent communication of risks and benefits in absolute terms. I now ensure my heart attack patients know that if they do not suffer side effects, there is a one in 83 chance taking a statin will prolong their life and a one in 39 chance it will prevent a non-fatal heart attack. But such discussion is not part of routine practice where doctors are instructed to follow guidelines in order to hit “targets” to get cholesterol as low as possible without any transparent rigorous evidence.

For years I prescribed statins, telling patients statins are wonder drugs, that they need to take them religiously every day, and that side effects were rare. I now realize nothing could be further from the truth. If the published data is to be completely trusted, many would find statins’ effects very underwhelming. For example, if you do not have heart disease and have not suffered a heart attack, there is no mortality benefit and approximately a one in 100 chance statins will prevent a minor heart attack or non-disabling stroke (15).

So why is such straightforward information not easily and readily available to both doctors and patients in the consultation room? It is most likely because the majority of patients would choose not to take the pill given that information, and that is not good news for the drug companies. But who can blame the pharmaceutical industry? It has a fiduciary obligation to provide profit to shareholders, not to give patients the best treatment. The real scandal is that many of those with a responsibility to patients — doctors, medical journals, and academic institutions — collude with industry for financial gain.

Dr. Aseem Malhotra is an honorary consultant cardiologist at Lister Hospital in Stevenage, U.K., and visiting Professor of Evidence-Based Medicine at the Bahiana School of Medicine and Public Health in Salvador, Brazil. He is a founding member of Action on Sugar and has led work highlighting the harm caused by excess sugar consumption in the U.K., particularly its role in Type 2 diabetes and obesity. He has also been prominent in challenging mainstream advice on the role of saturated fat and cholesterol in the development of cardiovascular disease. In 2015, he coordinated the Choosing Wisely campaign by the Academy of Medical Royal Colleges (AoMRC) as lead author in a BMJ paper highlighting the risks of overuse of medical treatments. In the same year, he became the youngest member to be appointed to the board of trustees of U.K. health think tank the King’s Fund, which advises the government on health policy. Malhotra is a frequent expert commentator in print and broadcast media and has written for a number of publications including the BMJ, The Guardian, Observer, BBC online, Huffington Post, The Daily Mirror, Daily Mail, The Daily Telegraph, and The Washington Post.

Notes

1. “Saturated fat is not the major issue”
2. “Association of dairy intake with cardiovascular disease and mortality in 21 countries from five continents (PURE): a prospective cohort study”
3. “Dietary carbohydrate restriction as the first approach in diabetes management: Critical review and evidence base”
4. “Risks of statin therapy in older adults”
5. “UK to charge soda tax on sugary drinks”
6. “Note on the reasons why the BMJ papers by Abramson et al and by Malhotra, along with their subsequent correspondence, should be retracted” 
7. “Doctors’ fears over statins may cost lives, says top medical researcher, Professor who sparked statins row says government should intervene”
8. “Nearly half of older patients stop taking statins within a year, study finds”
9. “Interpretation of the evidence for the efficacy and safety of statin therapy”
10. “Statins expert in row over level of risk to patients”
11. “The deadly propaganda of statin deniers”
12. “Review of statins needed, Statins review ‘urgently needed’ to find out if millions are benefiting from cholesterol drug”
13. Ibid.
14. “Clinical expertise in the era of evidence-based medicine and patient choice”
15. “Beyond confusion and controversy, can we evaluate the real efficacy and safety of cholesterol-lowering with statins?”