Have we Been Misled by the Evidence?
Dr. Maryanne Demasi
Webmaster Note: I’m reposting this article because I believe it is such an important topic and people need to understand what the science says. There are Nutritional approaches to cardiovascular health that have virtualy 100% chance of improving cardiovascular health without the risk of side effects statins impose. Please listen to Dr. Demasi’s analysis and discuss her information with your medical doctor before assuming statins are right for you. Pay close attention to this summary of an excerpt from Dr. Demasi’s transcript, and compare the 1.1% statin risk reduction with a nearly 100% side effect rate…
The talk then turns to how statistics can be used to exaggerate benefits, with Demasi dissecting a Lipitor advertisement claiming a 36 percent reduction in heart attack risk. In the underlying European Heart Journal trial, the placebo group’s heart attack risk was about 3.1 percent compared with 2.0 percent in the statin group—a relative risk reduction of roughly 36 percent but an absolute risk reduction of only 1.1 percent, a difference that looks far less impressive when presented honestly to patients weighing side effects against expected benefit.
Investigative medical journalist Dr. Maryanne Demasi examines whether the evidence backing widespread statin prescriptions truly supports their claimed life‑saving benefits, and what this means for patient choice and informed consent.
Dr. Maryanne Demasi, a former medical scientist and investigative health journalist, explains how statins became the world’s most prescribed cholesterol‑lowering drugs and why their use has expanded far beyond people at highest risk of heart disease. She walks through guideline changes, financial conflicts of interest, trial design biases, and secrecy around raw clinical trial data that may exaggerate statin benefits and underestimate side effects. Demasi also describes how critics of statin overuse have been discredited or censored, and she shares her own experience of professional backlash after questioning statin prescribing and industry influence on national television. Throughout, she argues for data transparency and honest communication of absolute benefit and risk so patients and doctors can make genuinely informed decisions about statin therapy.
Summary
- Statins are the most widely prescribed cholesterol‑lowering drugs globally, generating enormous revenues (projected to reach around one trillion US dollars by 2020) and driving what Demasi calls a “statin empire.”
- Indications for statins have progressively expanded from people with established heart disease to broader low‑risk populations, including proposals to medicate nearly everyone over 50, children with high cholesterol, and even suggestions such as statin‑fortified fast‑food condiments or adding statins to the water supply.
- Demasi details how guideline committees lowered the definition of “high cholesterol” and later shifted to risk calculators that significantly increased the number of people eligible for statins, often based on tools that appear to overestimate cardiovascular risk.
- She highlights serious concerns about industry influence: most statin trials are funded by manufacturers, raw trial data on side effects are held by a single Oxford‑based group with large industry funding, and independent researchers are contractually barred from examining the underlying data.
- The talk explains how trial designs (such as run‑in periods that remove patients who cannot tolerate statins) and the use of relative risk reduction instead of absolute risk reduction can minimize perceived harms and greatly magnify perceived benefits in both publications and drug advertising.
- Demasi describes powerful strategies used to silence dissent, including authoritative editorials, high‑profile meta‑analyses claiming to “end debate,” public accusations that critics are endangering lives, and professional attacks labeling skeptics as part of an “internet cult.”
- She recounts her own experience at ABC’s Catalyst program, where a two‑part series questioning saturated fat and statin over‑prescription triggered a coordinated backlash from heart foundations, drug companies, and some cardiologists, culminating in accusations that the program would cause thousands of deaths and in the eventual removal of the episodes and disbanding of the team.
- The talk closes with a French case study where media criticism of statins led to increased statin discontinuation; contrary to dire predictions, national statistics showed deaths decreased the following year, reinforcing Demasi’s call for real‑world data and transparency instead of speculative extrapolations.
Transcript Summary
Who Dr. Demasi Is
Dr. Maryanne Demasi introduces herself as a former scientist with a PhD in rheumatology whose research has been published in international medical journals and who later became an investigative journalist for the ABC Catalyst program. She explains that she now works with the Nordic Cochrane Collaboration, a consortium of scientists that conducts health and medical research without industry funding, and that her talk is based on her peer‑reviewed narrative review “Statin Wars: Have we been misled by the evidence?” published in the British Journal of Sports Medicine.
How Statins Became Big Business
Demasi outlines how statins have become the most widely prescribed cholesterol‑lowering drugs in the world and notes that Lipitor is the most profitable drug in medical history, with overall statin sales expected to reach about one trillion US dollars by 2020 despite patent expirations. She describes an exponential rise in prescribing, starting with high‑risk patients who already had heart attacks or strokes and then expanding via influential advocacy to include nearly everyone over 50, children screened for high cholesterol (with even grape‑flavored statins marketed), and provocative suggestions like offering statins as condiments at fast‑food outlets or adding them to public water supplies.
Expanding Indications by Redefining Risk
She argues that “following the money” helps explain why statin use spread so dramatically, pointing out that it is cheaper for companies to extend indications for existing drugs than to develop new ones. In the early 2000s, the U.S. National Cholesterol Education Program lowered the numerical threshold for “high cholesterol” without new science, instantly making millions more people eligible for statins and reinforcing the idea that “the lower the better,” even though most of the guideline authors had direct financial ties to statin manufacturers.
Risk Calculators and Overestimation
In 2013, U.S. guidelines shifted from focusing on cholesterol levels alone to using global cardiovascular risk calculators, such that anyone with a 7.5 percent ten‑year risk would qualify for a statin, far lower than the 20 percent threshold used in the UK. Demasi notes that this change added about 12.8 million more Americans to the statin‑eligible pool, largely older people without established heart disease who would gain minimal benefit, and that research found many risk calculators overestimated risk, some by up to 115 percent, fueling concerns about overdiagnosis and overtreatment.
Industry‑Funded Trials and Data Secrecy
Demasi then focuses on industry bias, explaining that after cuts in U.S. public research funding during the Reagan era, drug companies began sponsoring their own large clinical trials, including virtually all important statin trials. She cites Cochrane evidence that industry‑funded trials tend to exaggerate benefits and downplay harms, and criticizes the CTT Collaboration at Oxford, led by Professor Rory Collins, which holds all the raw data on statin side effects under contracts with drug companies while receiving hundreds of millions of pounds from statin manufacturers, yet does not allow truly independent scrutiny of the data.
Why Transparency Matters
She argues that this lack of data sharing undermines the scientific process, because science depends on contestability, replication, and independent analysis to validate findings and quantify harms and benefits. According to Demasi, when companies and their closely allied groups control the data and refuse transparency, clinical evidence becomes a form of marketing rather than science, leaving both patients and prescribing doctors without balanced information needed for informed decision‑making.
Lessons from Tamiflu
To illustrate the need for full data access, Demasi recounts the Tamiflu story, where governments stockpiled the drug based on company claims that it shortened flu duration and reduced complications. She describes how persistent efforts by Cochrane researchers and the British Medical Journal eventually forced release of the clinical trial reports, revealing that Tamiflu was much less effective than claimed, had more side effects, and did not significantly reduce hospital complications, suggesting it performed little better than inexpensive paracetamol.
Trial Design That Minimizes Harms
Demasi explains how statin trials can be designed to minimize apparent side effects, focusing on the Heart Protection Study, which used a “run‑in period” where all participants were given the drug for several weeks before randomization. She notes that roughly 36 percent dropped out during this phase—often due to side effects—so only the tolerant remainder were randomized, meaning that final comparisons between statin and placebo groups inevitably underrepresent real‑world intolerance and produce side‑effect rates far lower than those seen in everyday practice.
Relative vs Absolute Risk
The talk then turns to how statistics can be used to exaggerate benefits, with Demasi dissecting a Lipitor advertisement claiming a 36 percent reduction in heart attack risk. In the underlying European Heart Journal trial, the placebo group’s heart attack risk was about 3.1 percent compared with 2.0 percent in the statin group—a relative risk reduction of roughly 36 percent but an absolute risk reduction of only 1.1 percent, a difference that looks far less impressive when presented honestly to patients weighing side effects against expected benefit.
Impact on Patient Decisions
Demasi emphasizes that patients often feel intense pressure to stay on statins out of fear of dying if they stop, yet many experience substantial muscle pain, brain fog, memory problems, and impaired functioning. She argues that clearly presenting absolute risk reduction, rather than only relative risk, can empower patients to decide whether a roughly 1 percent absolute reduction in events is worth potential side effects, instead of being frightened into unquestioning compliance.
Silencing Dissent in Journals and Media
Demasi describes how powerful publications and public statements are used to quell debate, citing a 30‑page Lancet review led by Rory Collins that claimed to end the statin debate and reassure the public that statins are safe and beneficial even for low‑risk people. This paper received extensive media coverage in the UK, US, and Australia, and critics who continued to question statin safety or benefit were accused of causing harm and of contributing to unnecessary deaths, which she views as an attempt to intimidate and discredit.
Labeling Critics as Dangerous or “Cult‑Like”
She notes that Collins publicly compared statin critics to those behind the infamous MMR vaccine scare, saying they may have killed more people, while another prominent cardiologist described opposition to statins as an “internet cult,” framing skeptics as irrational and dangerous. Demasi argues that such rhetoric discourages open scientific debate and helps shield industry‑friendly narratives from legitimate scrutiny.
The ABC Catalyst Controversy
The talk then moves to her own experience at ABC Catalyst, where she produced a two‑part series called “Heart of the Matter.” The first episode questioned the link between saturated fat, cholesterol, and heart disease, and the second, “Cholesterol Drug Wars,” examined statin over‑prescription and industry influence; together they attracted large audiences and widespread public support before drawing intense criticism from the Heart Foundation, drug companies, and some cardiologists.
Backlash, Accusations, and Censorship
Demasi recounts how ABC’s own health commentator claimed on national radio that people would die if they watched the program, while leading cardiologists publicly accused the network of having “blood on its hands” and encouraged patients to sue if they stopped statins and experienced heart attacks. A subsequent article in the Medical Journal of Australia predicted the programs would cause thousands of additional heart attacks and strokes, and under mounting pressure, the ABC removed the episodes from its website, disbanded the Catalyst team, and placed staff under a gag order so they could not defend their work.
French Case Study on Statin Discontinuation
Demasi concludes with a French case in which a cardiologist’s critical book on statins and consequent media coverage led to a significant increase in statin discontinuation. While commentators predicted that this would result in about 10,000 extra deaths, follow‑up analysis of national data showed that mortality actually decreased in the subsequent year, leading researchers to argue that claims about increased deaths from statin discontinuation were not evidence‑based and that future assessments should rely on real outcomes rather than speculative extrapolations.
Call for Transparency and Informed Choice
She ends by reiterating that statin science is clouded by secrecy, trial design issues, and conflicts of interest that distort both benefit and harm estimates. Demasi calls for open access to raw trial data, independent re‑analysis, and honest communication of absolute risk reduction so clinicians and patients can have informed, evidence‑based conversations rather than being driven by fear or marketing.
