Dr Maryanne Demasi responds to The Heart of the Matter

 (14/11/2013)

What was it about Catalyst’s screening of HEART OF THE MATTER that provoked such a fierce response from critics?

The suggestion that ‘people will die’ as a result of watching Catalyst is not sustainable. Any article or program about a medical treatment could potentially lead to an individual reconsidering their own situation. At no point did I suggest that patients throw away their medicine and potentially endanger their health. Instead, the program advised viewers to consult with their doctors before considering any change to their medical regime.

I questioned the widely held belief that saturated fat causes heart disease by raising cholesterol. Additionally, I highlighted some of the major studies undertaken to prove this hypothesis, which ultimately failed to do so. So, why did they fail? As stated by The National Heart Foundation of Australia in the Catalyst program, nutrition trials are complex and “to imagine creating a study that would prove that conclusively is virtually impossible”.

However, what really drew the ire of some doctors was when other doctors suggested that the benefits of cholesterol lowering medication have been exaggerated, and that they are likely being prescribed for people who don’t need them.

I believe this is a legitimate area of journalistic inquiry, and so it’s been disappointing to see some doctors and even some fellow journalists mis-characterise the program or question the integrity of the interviewees.

For example, Catalyst has been criticised for relying on the on-screen testimony of a few “fringe dwellers”. Over 3 years of research, I spoke to some of Australia’s most well known and distinguished cardiologists, along with dozens of other sources. Sadly, many of those interviewed did not want to comment on the record, or were concerned that it would jeopardise their funding opportunities.

Critics have pointed out that some of our interviewees had a conflict of interest through their commercial activities, but they remain oblivious to the conflicts of interest of those opposing our analysis.

The main medications which lower cholesterol, called statins, have been touted as ‘wonder drugs’ and are one of the most widely prescribed class of drugs in medical history. Indeed, many experts do believe that the widespread use of statins is justified. No one doubts their effectiveness at lowering cholesterol, but there are doubts about whether this translates into a worthwhile benefit for all patients.

At first, these drugs were shown to delay death in high risk patients – those who’d suffered from heart attack or stroke. This strategy is called ‘secondary prevention’, because you’re preventing a second heart attack.

Drug companies then explored the benefits of expanding the use of statins into the wider population. Large clinical trials tested statins in those who did not have existing heart disease (so called ‘primary prevention’, to avoid a primary heart attack).

In Catalyst’s program we quoted a figure known as the “number needed to treat (NNT)” which is basically the number of people you need to treat to save one life. This is calculated on the existing clinical trials involving statins. In those at the highest risk, for example those who have suffered a previous heart attack, taking a statin is beneficial. This was stated in our program.

However, the numbers say that statins in these high risk patients will delay the death of 2 in every 100 people treated with a statin. As Prof Rita Redberg from the University of California San Francisco, pointed out to Catalyst, the other 98 people won’t live any longer by taking the drug. This is a fact according to TheNNT.com. However, it is rarely couched in those terms to the patients.

Why is this useful for a patient to know? Well, too often patients are made to feel that if they don’t take their medication they “will die”. However, if the patient is experiencing life altering side effects from the drug, then perhaps it may give them ease to know that they only have a 2/100 chance of living longer anyway (TheNNT.com).

For people without diagnosed heart disease (primary prevention) the statistical benefit of living longer is less convincing. The majority of people taking statins are in the primary prevention category. The data suggests that no lives will be saved by taking the drug (again, see TheNNT.com). In the opinion of some independent sources e.g. Therapeutics Initiative too few lives will be saved to justify giving statins to these people for the rest of their lives and so exposing them to the side effects of the medications. This is what is up for debate.

Perhaps there needs to be a shift in the debate from who should be on statins, to who should not be on statins?

These drugs can reduce the risk of cardiovascular disease, but they may promote other potentially life-shortening illnesses like diabetes. So, overall, it’s unlikely that people at lower risk will live any longer by taking a statin. As Harvard Lecturer, Dr Abramson said in the Catalyst program, if you have a particular fear of heart disease, but as yet no actual heart disease, then by all means, take a statin, but know that you will expose yourself to the potential risks of the drug and your overall lifespan probably won’t change.

The information I quoted from TheNNT.com, a group with no outside funding and no conflicts of interest, considered a range of studies, including the much talked about Cochrane Review of 2013, which some of our critics have quoted in an attempt to question Catalyst’s conclusions.

Understandably, public health advocates and cardiologists are focused on reducing your risk of heart disease because it comes with a significant health burden. But what matters to many patients is whether the drug will help them live longer, not shift the cause of death from one disease to another. It’s possible that many patients care less about what they die from, if it means not having to take a pill every day.

Why do we hear such dramatic reductions in risk of heart disease, like 30% reduction or 50% reduction? Well, it’s all in the way you express the percentage risk to the patient – absolute risk versus relative risk. A simple example is this: You might have a 2 in 100 chance of developing a disease, but then you take a drug and it reduces that risk to 1 in 100. That’s a relative reduction in risk of 50% (sounds impressive) but the absolute reduction is only 1% (not so impressive). When you hear about the benefits of medications, they often quote the relative percentages which sound a lot more impressive than absolute percentage reductions.

When we talk about ‘reducing a patient’s absolute risk’ in primary prevention, we’re often talking about only a few percentage points. That’s why, when medicating relatively healthy people with a drug that exposes them to side effects, you want to be confident you are achieving an overall benefit for the patient – not just focusing on heart disease and overlooking other problems that arise. When you consider the inherent issues of drug funded trials and bias in the medical literature, it’s reasonable for someone like Prof Redberg to be hesitant about medicating everyone over the age of 50, regardless of their cholesterol level.

She believes we’re not saving lives, or if we are, it may be that there are too few to warrant exposing so many more people to a lifelong medication that has side effects.

The argument is often raised that the duration of primary prevention trials have not been long enough to demonstrate a mortality benefit and that the benefits of taking a statin would accumulate over time. However, Ass Prof David Newman from Mount Sinai School of Medicine in New York says, this is an “imaginary benefit”. He explains, “Diabetes problems are likely to increase with increasing years, so the idea that [statin] benefits would accrue, but somehow the adverse effects would not, or that the benefits would suddenly start to outpace the harms, is exuberant projection”. Ass Prof Newman continues, “It is not rooted in fact and would not be an argument for treatment unless this was explicitly discussed and understood between patient and doctor.”

I still can’t fathom why this is such a difficult concept to grasp from the “opinion leaders” who’ve spoken out in criticism of the program. Even Dr Rob Grenfell from the Heart Foundation told Catalyst, “I would agree that there are people in Australia today who are being treated for cholesterol where their cardiovascular risk is not high. And you have to question whether they should in fact actually be on that.”

During the three years I was researching this story, I discovered many patients who are miserable on these drugs, but persist because they fear they will die. Many patients complained that some doctors dismissed the side effects of the drugs by saying “you’re getting older”, “it’s probably your imagination” or “it’s not the statins, it’s probably something else to blame”. Howeveer, Prof Redberg claimed that many of her patients report the side effects disappear once they cease their medication. Dr Beatrice Golomb says some patients take months to recover, others never recover from side effects.

I felt it was important to explore ways in which the side effects in some clinical trials are underestimated.

Catalyst doesn’t give medical advice but seeks to raise awareness of important issues that matter to people. Your doctor will always be the right source for personalised medical advice. I’ve presented the best, most independent evidence on statins available to date (TheNNT.com; Therapeutics Initiative).

I’ve explored the potential conflicts of interest when drug companies sponsor their own clinical trials and it’s now up to the patient to have a conversation with their doctor. The fact that patients are flocking to their GP’s to question their medications is good news as far as I am concerned.

One of Catalyst’s critics, the RACGP, has credited us with raising a list of some important issues to debate:

• inappropriate usage of statins in low and moderate risk groups

• the need for promotion of non drug interventions (non smoking, exercise, Mediterranean diet) in the management of cardiovascular disease

• the concern of drug company influence on clinical trials, and these companies withholding data from such trials

• doctors with ties to the pharmaceutical industry that have substantial influence in guideline groups, and the need for open disclosure standards

• the role of drug companies influencing prescribing of practitioners

• the dangers of changing ‘disease definitions’, specifically what level of cholesterol is considered ‘abnormal’, that results in more drug use

• over diagnosis becoming a significant issue in health.

It’s important to empower patients with the information they need to make the best decisions about their health in consultation with their trusted physician.

For more information refer to TheNNT.com.

Dr Maryanne Demasi, PhD. I have no conflicts of interest.