Junkfood Science: When evidence-based clinical guidelines aren’t

June 27, 2007

When evidence-based clinical guidelines aren’t

There’s been a lot of talk lately that our health might be more ideally managed by the government. Some trust the government to know what’s best for us. While it might be a comforting thought to believe an omnipotent entity will take care of everything on our behalf, how many of us have investigated for ourselves the reality of that?

Today’s news from England provides a glimpse. New clinical guidelines under the national healthcare system will direct doctors to identify people whose health risk numbers fall outside ideal ranges, and track them down for blood testing and prescribed medications.

This morning, the Telegraph announced that new government guidelines for cholesterol management for the primary and secondary prevention of cardiovascular disease had just been drafted. According to the Telegraph, they would mandate:

GPs...to draw up a “systematic strategy" to identify which patients on their books are most at risk of developing heart disease. These patients will then be called to their local clinic or health centre for blood tests to measure their cholesterol levels, the guidance from the National Institute for Health and Clinical Excellence (NICE) will say. People who are found to have a 20 percent or greater chance of developing cardiovascular disease over the next decade will be prescribed statins to try to reduce their cholesterol.

These go further than the national screening programs already in place for breast and cervical cancer, for example. The article said:

[T]he NICE plans for heart disease will ask GPs to use information they already have on patients — including whether they smoke, their weight and family history — to identify those most at risk of developing heart problems. It would then be up to GPs to arrange for these patients to have their cholesterol measured to see if they should be prescribed statins. Sources stressed that there was no age limit on who would be covered by the guidelines...

“Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease”

This NICE guideline states it is “based on the best available evidence.” Far from being evidence-based, however, determinations of those at risk for cardiovascular disease, and hence, to be prescribed statins, are to be made using the Framingham risk score. In actuality, as we’ve seen, those popular heart disease risk factors don’t predict disease or premature death for most people, nor is the evidence in support of statins for the primary prevention of cardiovascular disease nearly as conclusive as popularly believed. The evidence for cholesterol and statin guidelines for children and adolescents is even more lacking.

Yet, for the primary prevention of cardiovascular disease, for instance, the guidelines call for identifying patients through electronic medical records which will calculate their risks using their BMI, age, gender, smoking status, blood pressure and cholesterol test results. All those with a Framingham risk score of 20% are recommended for statins.

This new NICE guideline will result in an estimated 14 million people in the UK being put on statins and about 28 million new consultations with GPs, equivalent to the entire workload of 14,000 GPs, according to Dr. Malcolm Kendrick, author of the Great Cholesterol Con. As he told the Daily Mail: “This programme is a complete waste of time. The cost will be about £3billion [nearly $6 billion in U.S. dollars] a year, for very little benefit.”

The guideline also includes “healthy” lifestyle modifications for the primary prevention of heart disease — nearly identical to those just reviewed and issued by the American Heart Association here. They include a low-fat diet, with saturated fats 10% or less, dietary cholesterol less than 300 mg/day, five daily servings of produce, and two weekly servings of fish. Stop smoking. And the guideline states that people who are overweight or obese should “achieve and maintain a healthy weight in line with the NICE guideline ‘Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children.’”

To support these brazen interventions, the NICE guideline (draft here) states that there’s an epidemic of cardiovascular disease that has been “socially generated” by people eating diets high in fat and salt, being sedentary and smoking. Yet in the very next sentence they admit that death rates have halved since the 1970s and 1980s!

NHS practice guidelines

This is just one of a multitude of “evidence-based” clinical practice guidelines that have been developed by NICE to be followed by doctors in the British National Health Services (NHS). Their national contracts call for them to follow NICE best practices and these are increasingly viewed in a regulatory light rather than advice. The NICE guidelines cover a vast array of conditions and can be viewed here.

It’s all in the name of wellness and keeping people healthy, which sounds well and good except for the fact that “health” is defined by the government. Their definition of health, and beliefs of how to achieve it, however, don’t enjoy especially sound evidence and may not be what you or your doctor believe appropriate for you, either. But under a national healthcare system, you can’t change healthcare systems.

Like here, many NICE preventive health measures are largely based upon maintaining idealized health risk indices — from BMI, blood pressure, blood sugars, bone densities, to cholesterol — which are believed to prevent chronic diseases of aging and premature death. Except, these indices have been shown to be largely genetic and related to aging, and not significantly malleable with “healthful” lifestyles. The ideal health indices have also been redefined over the years, despite considerable controversy about the soundness of the evidence behind those changes, so that most adults now fall outside of ideal ranges. The end result is a fair amount of compulsory interventions and medications.

Many of the NICE preventive health guidelines are strikingly similar to the employer-insurer wellness and weight management programs and pay-for-performance measures being proposed by insurers here in the United States.

The NHS has been incentizing compliance by rewarding doctors since 2004 with bonuses for complying with these quality measures and by the greater number of healthy patients they have. The NHS is making it irresistibly lucrative for GPs — compliance with all of the new clinical measures equates to 50% of their total compensation. According to the Information Centre for Health and Social Care, salaries rose by 30% during 2004-2005 when contracts were radically changed to begin to reward those performing more screenings and services, and improving patient outcomes. The average GP salary is now about $215,000 (in U.S. dollars), with those attached to pharmacies averaging even more. But salary figures from the Association of Independent Specialist Medical Accountants suggest some are earning up to $500,000 (U.S. dollars). The Quality and Outcomes Framework provides 1050 points for doctors who meet all of the clinical targets and each point is worth an additional 120 pounds pay ($239 in U.S. dollars).

No one has mentioned, however, how these incentives bode for people who are sick, who don’t agree to undergo tests and take medications, and whose health indices are outside ideal ranges — i.e. are older, fat, genetically predisposed, or among minority and discriminated groups.

While the guidelines say that patients may choose to not go along with the NICE guidelines and may refuse the interventions, just imagine how popular that will make you with your doctor!

“Obesity: prevention, identification, assessment and management of overweight and obesity in adults and children”

What may be of special interest to readers here are the NICE guidelines for obesity that were issued last December. They define what GPs should do to assess people’s weight status, help people lose weight, and make sure they and their children stay at a “healthy weight.” These wide-ranging recommendations aren’t just for the NHS, but also state what actions must be taken by local authorities, employers, town planners, communities, childcare providers and schools to stop the epidemic of obesity claimed to be threatening the health of the country. There is also a guideline for patients.

The clinical practice guidelines open by saying: “The recommendations are based on the best available evidence of effectiveness, including cost effectiveness. The prevention and management of obesity should be a priority for all, because of the considerable health benefits of maintaining a healthy weight — as defined as a BMI of 18.5-24.9 — and the health risks associated with overweight and obesity.” [There’s no need to explain the fallacies for readers here.]

These guidelines were developed by a long list of NHS staff, local authorities and other public bodies in the Guidance Development Group, chaired by Professor James McEwen of the University of Glasgow and chair of PharmacyHealthLink. It worked along with about 250 stakeholder organizations which included the major pharmaceutical companies, Atkins Nutritional, Inc., various obesity and bariatric trade associations, International Obesity Taskforce of the International Association for the Study of Obesity, Slim-Fast Foods Ltd, Weight Watchers UK, etc. Like here, it’s naive to believe that government public health guidelines are immune from powerful marketing and political influences.

These obesity guidelines bear a striking resemblance to those recently proposed by the AMA, HHS and CDC here. The clinical management includes the assessments of patient’s BMI and lifestyles; referral of overweight children and adults to specialists; weight loss programs that encourage healthy low-fat, low-calorie diets and exercise and expect weight loss of 1-2 pounds a week; counseling for behavioral changes; obese adults who have reached a plateau in weight loss may be put on very low calorie diets of less than 1,000 kcal/day for 3 months; clinical tests for both children and adults to identify comorbidities (cholesterol, blood pressure, insulin and glucose, liver and endocrine function, etc.); drugs should be considered for those failing to reach their target weight (orlistat or sibutramine are also recommended for children 12 years and older with comorbidities) and may be used indefinitely to maintain weight loss after consultation with providers; and bariatric surgery is recommended for adults with BMIs of 40 or more, or 35 with healthrisks “who have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months” and should be the “first-line option for adults with a BMI of 50 or more” who can undergo surgery. Families are expected to eat regular meals together without television, including breakfast, encourage active play and discourage sedentary activities in children.

Public health officials in the UK have been doing their part in promoting their government’s health program with various lifestyle initiatives, too. We’ve already heard about their recent bans against advertising of such “unhealthy” foods as milk and eggs. Spiked-online recently discussed the NHS’s alcohol strategy to discourage even responsible drinking at home.

Monday, the media reported on new research by Lloydspharmacy finding that nearly 2,1000 GPs and 54,600 nurses still haven’t quit smoking and the smoking ban across England is due to go into effect in just two weeks. It found there were about 13 million smokers in the UK who will be affected by these new smoking bans.

Last week, a new white paper was released to reform its National Health Services. At the heart was “a new public health act and efforts to fight obesity.” Financial Times reported:

People would be asked to take more responsibility for their lifestyle with a focus on tackling drugs and obesity and cutting tobacco and alcohol consumption. The report will propose “a new partnership with the professions” that gives staff a bigger say in decision-making and addresses “failures of employment practice.”

The BBC describes in more detail the heightened coercion the public may feel from government-paid healthcare providers to comply with government’s healthy lifestyles:

More emphasis should be put on tackling public health issues like obesity, drugs, smoking and alcohol, says a Conservative health policy review. It proposes measures to strengthen the Chief Medical Officer's office, with a separate budget for public health - and all government departments involved. It also seeks to cut NHS red tape and proposes more powers for patients....The policy review group says people should take individual “responsibility" for their health, with the government informing people of potential dangers of their lifestyle choices... They should also help establish a set of “outcome measurements" to show how individual trusts and hospitals are performing. A “health watch" body should be set up to monitor local health services on behalf of local communities.

Reading all of this leaves us with a better understanding of the challenges faced daily by those who may choose to enjoy a lifestyle different from one their government approves of or who have bodies that don’t fit the mold, and for healthcare providers who work to provide the quality care best for their patients. Most of all, it reminds us of the value of looking beyond what sounds good to what might actually be good.

© 2007 Sandy Szwarc

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