November 11, 2011 was a happy day for Big Pharma. That’s the day when The National Heart, Lung and Blood Institute issued new guidelines recommending that every child’s first cholesterol check should occur before the kid hits puberty, between the age of 9-11. As the Wall Street Journal reported at the time, the guidelines also come amid broad concern about growing numbers of children who are overweight or obese (as about 17% of the little darlings are, triple the level from three decades ago).
These children, say those who wrote these guidelines, are thus potentially on course for diabetes, high blood pressure, heart disease and other serious health problems as adults.
With all due respect to the very smart doctors who came up with what amounts to a resounding high-five victory for marketing-based medicine, I feel compelled to ask:
“What were you thinking?”
Even though the new guidelines contain a mandatory cautionary note (“Drugs? What drugs?”) the corporate pharmaceutical windfall that’s implicit in them is worth celebrating if you happen to own stock in Big Pharma. The WSJ explained:
“While broad screening could also increase the numbers of children prescribed cholesterol-lowering drugs called statins, doctors cautioned against reading the new guidelines as a call for using medication.”
Really? Seriously? Does anybody actually believe that many doctors are not going to reach for the prescription pad once these new guidelines for children are widely implemented?
Statin drugs for cholesterol management are already considered the rock stars of the pharmaceutical world. Consider Pfizer’s statin Lipitor, the planet’s biggest selling drug, accounting for $106 billion in sales over the last decade, or almost one-quarter of the company’s total sales. But the drug is about to lose its patent protection, opening up the market to generic versions of the drug – a potentially devastating blow to Pfizer’s bottom line. (See also: Lipitor and Nine Other Blockbuster Drugs That Are Falling Off the Patent Cliff).
And about one in three of us over the age of 40 are already taking a statin drug such as Lipitor, whether we’ve ever had a cardiac event or not.
Here in Canada, according to IMS Brogan (a company that tracks pharmaceutical marketing), we Canadians spent more than $2 billion on more than 30 million statin prescriptions last year. Those figures have risen steadily in just the past four years; in 2006, fewer than 21 million statin prescriptions were dispensed. Doctors – and the drug sales reps who help to educate doctors – are clearly in love with statins.
Statins represent a fantasy dream-come-true if you’re a drug company that makes them – a prescription drug that a reasonably healthy middle-aged person will take every single day for the rest of their lives! But imagine how much happier you and your Big Pharma shareholders would be if you could turn statins into commonly-accepted drugs for all chubby children.
I’ve heard cardiologists joke (at least, I think they were joking) that we ought to be putting statins into the drinking water. These guidelines just might be the next best thing.
A number of emerging studies, however, (like this one last year from the independent Cochrane Library) conclude that there is “no strong evidence” to suggest that statins reduce coronary heart disease deaths among those who have not already suffered a heart attack or other cardiovascular event in the past. (This essentially includes almost all children).
The Cochrane findings, by the way, also criticized industry-funded statin studies that included “selective reporting of outcomes, failure to report adverse events, and the inclusion of people with cardiovascular disease in published studies on low-risk patients”.
There are a number of serious concerns if doctors do start prescribing statin drugs to their younger patients based on these new cholesterol screening test results. Which, of course, they will.
Statins are FDA-approved for children and teens under age 18, but only if they have a genetic condition that causes extremely high levels of LDL (bad) cholesterol. Yet in 2009, pediatricians wrote American children at least 2.3 million prescriptions for statins. These 2.3 million prescriptions, by the way, do not include those prescriptions written by family doctors or other pediatric specialists.
Some critics are concerned about the unknown long-term potential side effect risks for children and adolescents who use these medications for years or even decades, particularly the effects on the developing central nervous system, hormone levels, immune function, and organs. Lipids play a role in brain development, and at least two statins, simvastatin (Zocor and generics) and lovastatin (Altoprev, Mevacor, and generics) can cross the blood-brain barrier and could have a direct and negative impact on such development, according to a 2008 editorial* in the Canadian Medical Association Journal. The editorial was summarized like this:
“The beguiling ease of prescribing a pill may be an ill-considered decision to commit our youngest patients indefinitely to an unknown balance between benefit and harm.”
The new guidelines’ lead author is Dr. Stephen R. Daniels of the University of Colorado School of Medicine, who chaired the task force that wrote them. His team hopes to identify those kids who are setting themselves up for an unhealthy future:
“We’ve learned that risk factors we’re used to thinking of as problems in adults are already at work in childhood.“
He added that strategies for addressing high cholesterol in children are similar to those for adults: “a strong emphasis on diet and increasing exercise”.
So if the guidelines are now recommending doctorly interventions to achieve these healthier lifestyle changes (without statin drugs), why aren’t doctors already aggressively promoting lifestyle changes to all of their young patients?
Despite what’s been called an ‘epidemic of obesity’ among our children, many doctors are somehow reluctant to incorporate fitness, nutrition and weight management instructions for high-risk patients in their practice. Researchers at UCLA’s Center for Human Nutrition, for example, reported in the journal Obesity:
“Most primary care physicians do not treat obesity, citing lack of time, resources, insurance reimbursement, and knowledge of effective interventions as significant barriers.”
Why would we now believe that these very same physicians are suddenly going to launch into proactive lifestyle counselling for at-risk children who are overweight, unfit or eating unhealthy food just because the doctors now know the kids’ LDL numbers? Wouldn’t they instead be far more likely to reach for that prescription pad?
Ironically, a different group of American government advisers, the U.S. Preventive Services Task Force, concluded in 2007 that there’s not enough known about the possible benefits and harms to recommend for or against cholesterol screening for children and teens. One of its leaders, Dr. Michael LeFevre at the University of Missouri, said that for the task force to declare screening beneficial there must be evidence that treatment improves health, such as preventing heart attacks, rather than just nudges down a number — the cholesterol score.
So, as in so much medical “news”, you have one group of brainiacs making claims that are disputed by another group of brainiacs. Which brainiacs should we now trust?
I am, it seems, not alone in my concerns about these new guidelines.
Consider the common-sense voice of reason from Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who is equally skeptical. She told the WSJ:
“I don’t know of any data that screening children ages 9 to 11 is of any benefit to them. We don’t need to do cholesterol tests to advise children to eat fruits and vegetables, watch their weight and get regular physical activity.”
And here’s another sane perspective from cardiologist Dr. Steven Nissen of the Cleveland Clinic, widely considered the top heart institute in North America. He slammed the new guidelines as “irrational” during a Heartwire interview, adding:
“Pediatricians have pushed widespread cholesterol screening forward in the absence of evidence supporting pharmacologic interventions if children are found to have elevated LDL-cholesterol levels. While the guidelines stress dietary and lifestyle intervention in kids with elevated cholesterol levels, the temptation to use the drugs in this population will be too high.
“Plus, what is the 20-year risk of cardiovascular disease in a patient who is 11 years old? It’s zero.”
On the other hand, his Cleveland Clinic colleague, pediatrician Dr. Ellen Rome said in a WebMD interview that parents should view the new cholesterol screening guidelines as “a wake-up call“ to make necessary lifestyle changes.
“Now, (parents) will be more likely to say, ‘Wow, we really do need to stop going to McDonald’s five nights a week and start eating meals at home!'”
(Earth to Dr. Rome: you don’t need cholesterol screening results in order to say something like that to your family!)
I asked the Canadian health policy analyst Alan Cassels here at the University of Victoria for his take on these new guidelines. Cassels, co-author of the book, Selling Sickness: How the World’s Biggest Pharmaceutical Companies are Turning Us All into Patients, was brutally blunt:
“I think that screening children for high cholesterol is unproven, dangerous, and disingenuous.
“Recommendations to expand cholesterol screening in kids is potentially very lucrative for drug companies but crass in its insistence that our doctors don’t have anything better to do than help expand markets for drugs designed to prevent heart disease in elderly people.
“Let’s be clear about statins: these drugs aren’t tolerated by 20% of the people who take them, and they have never been adequately tested in children. Do we want to create a whole new cohort of ‘statin-damaged’ people on the wisps of hope that we’re helping them?
“Thankfully not all doctors are going to buy this latest recommendation, especially ones who can still access basic common sense. Yet the pediatricians involved in creating this recommendation are just providing another brick of proof that we can’t trust their drug-addled decisions anymore, that they’ve lost any vestiges of the Hippocratic oath promising not to harm the youngest and most vulnerable in society.
“As consumers, probably the best thing we can do is keep them away from our children.”
Find out what Alan really thinks of this topic in his Victoria Times Colonist article “Screening Kids For High Cholesterol Is Just Silly”.
Maybe some of us might be less cranky about these new guidelines if it weren’t for the fact that the lead author is Dr. Daniels.
Turns out that Dr. D’s admitted conflicts of interests include receiving grant money from the very drug companies that happen to make our best-selling cholesterol meds, and who thus stand to gain financially should these new screening guidelines for kids be widely implemented. These drug companies include Pfizer (Lipitor), AstraZeneca (Crestor), and Schering-Plough (Vytorin, Zetia). Daniels has also served as a hired consultant for Merck (Zocor) and Abbott Labs (non-statin anti-cholesterol drug TriLipix, which by the way, garnered an FDA safety warning this month due to “an increase in the risk for major adverse cardiac events in women” ).
At least three other members of his guidelines team (some have estimated that number to be closer to eight) have also disclosed financial conflicts of interest based on their known industry funding relationships.
Even more likely to make us cranky, a study called Conflicts of Interest in Cardiovascular Clinical Practice Guidelines published in the Archives of Internal Medicine this year found that the chairs of these medical guideline writing committees are significantly more likely (81%) than committee members (55%) to have a potential conflict of interest with the pharmaceutical industry.***
This fact is not unique to these cholesterol screening guideline authors. Again, cardiologist Dr. Stephen Nissen has observed:
“No conceivable logic can defend the practice of including promotional speakers and stockholders on clinical practice guideline writing committees. Physicians paid to serve on drug company speaker’s bureaus essentially become temporary employees of industry, whose duty is the promotion of the company’s products.”
.© 2011 Carolyn Thomas – The Ethical Nag: Marketing Ethics for the Easily Swayed
- * CMAJ December 2, 2008 vol. 179 no. 12. 1239 10.1503/cmaj.081718 )
- ** Pediatrics Vol. 122 No. 1 July 1, 2008, pp. 198 -208 (doi: 10.1542/peds.2008-1349)
- *** Arch Intern Med Vol. 171 No.6 March 28, 2011;171(6):577-584
- Clinical Practice Guidelines vs Routine Breast Screening Mammography
- Can Statin Drugs Really Save Your Life?
- When Medical Research is Funded to Favour the Drug, Not the Facts
- Your Health, Ball Possession and the World Cup
- Zetia & Vytorin: How Merck Got Patients to Spend $21 Billion on Drugs That Don’t Work
- Study: Statin Drugs Over-prescribed for Healthy Adults
- Women at Greater Risk for Side Effects When Taking Statin Drugs
Remember when our acceptable cholesterol levels were much higher than they are now? I do. Were we told that the acceptable level has been lowered because new science showed that it should—– or was it simply to market more drugs?
I know what I think.
The following is from an article at the Weston A. Price web site; a site I’d advise should be read with your critical-thinking hat on. But it does give some hints as to where to go for more reading.
“ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial), the largest North American cholesterol-lowering trial ever, showed that mortality of the treatment group and controls after three or six years was identical. Researchers used data from more than 10,000 participants given cholesterol-lowering drugs and followed them over a period of four years, comparing the use of a statin drug to “usual care,” namely maintaining proper body weight, no smoking, regular exercise, etc., in treating subjects with moderately high levels of LDL-cholesterol. Of the 5170 subjects in the group that received statin drugs, 28 percent lowered their LDL-cholesterol significantly. And of the 5185 usual-care subjects, about 11 percent had a similar drop in LDL. But both groups showed the same rates of death, heart attack and heart disease.”
“While the evidence relating elevated cholesterol levels to CHD is strong and consistent, clinical trials have not demonstrated that cholesterol-lowering reduces total mortality. Moreover, observational studies show a U-shaped relationship of cholesterol and mortality, with higher mortality rates for persons with cholesterol levels less than 160 mg/dl and greater than 240 mg/dl compared to those in the range 160-240 mg/dl”
Thanks for pointing out that anything published on the Weston Price site should be read with one’s critical thinking hat on. But ALLHAT is a good example of cherry-picking study results (i.e. showed that LDL numbers went down in the group treated with pravastatin – intermediate endpoints – but only a ‘nonsignificant’ difference in disease/mortality rates between the two groups). ALLHAT was also criticized because 30% of its ‘usual care/non-statin’ group actually WERE prescribed statins during the course of the study. (How can you call these people non-statin users when they were taking statins?) Some experts at the time also theorized that the lack of a significant effect of pravastatin on clinical outcomes was because the trial was performed in patients with high blood pressure. And ALLHAT’s questionable conclusions:
“The ALLHAT lipid-lowering treatment study found only a small (nonsignificant) decrease in cardiovascular event rates for pravastatin compared to usual care, and no difference in mortality. But THESE RESULTS DO NOT ALTER CURRENT CHOLESTEROL TREATMENT GUIDELINES, which are based on a series of other clinical trials with larger cholesterol reductions than that observed in ALLHAT.”
In other words, pay no attention to the man behind the curtain . . .
I must have missed the ‘cherry-picking’ aspect of that ALLHAT article—- thank you. I should know that ALL studies should be analysed more carefully.
****THESE RESULTS DO NOT ALTER CURRENT CHOLESTEROL TREATMENT GUIDELINES, which are based on a series of other clinical trials with larger cholesterol reductions than that observed in ALLHAT.”
I took that sentence in the study as a CYA statement. That it wasn’t going to step-on ‘someone’s’ toes. What do you think?
Also this sentence: “But both groups showed the same rates of death, heart attack and heart disease.”
Is that based on shoddy statistics? I’m not questioning to be argumentative—– I really want to know, since statistics are definitely not my forte!
I’m not a statistician either, merely a dull-witted heart attack survivor who three years ago started questioning the fistful of cardiac meds prescribed for me. But if you google ALLHAT criticism, you’ll find a small avalanche of reports questioning this study’s conclusions, too. For example, this from the Canadian Medical Association Journal. “Questioning the Benefits of Statins”:
“What is the point of decreasing the number of “cardiac events” without decreasing overall mortality, when the harm caused by the side effects of statin therapy is factored in? The failure of statins to reduce all-cause mortality clearly supports the call for more effective approaches. Guidelines should reflect this finding, certainly in their recommendations for women.”
Apparently, the ALLHAT research teams were not quite so honest in their conclusions, given the clearly stated outcomes of their study.
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This is all about opening up a new market for statins at a time when the biggest selling one is losing its patent.
Yes it is – and, sadly for all these children, it will likely succeed.
Petr Skrabanek wrote in his book “The death of human medicine” a priceless passage which masterfully illustrated how we torment with the hammer of cholesterol lowering “evidences”, to the point of losing our head.
“Food faddism is not only an affection of the simple-minded. In a piece-of-mind article in the Journal of the American Medical Association, a cardiologist wrote touchingly about seeing his four-year-old daughter Ariel sneaking to the fridge in order to have some of the ice-cream that her granny had bought. ‘From conversation around the house she knew what foods were high in saturated fat and cholesterol and that they should be avoided’. She felt guilty and her daddy felt guilty about her guilt. He also felt guilty that he had not yet measured her cholesterol, but he consoled himself that ‘there is no uniform agreement among all experts on when to start screening small children’. Poor Ariel!”
Finally they’ve reached a consensus. Non sensus consensus, of course. Consensus, like most of them, harmful.
Poor Ariel, poor children!